title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Intervention | hypoglycemic, diabetes | DIABETES, CLAP, DIABETES | All participants continued to receive standard therapy for diabetes as they received before the study began. The control group continued the standard therapy and the intervention group received the standard therapy plus the laughter yoga program. Standard therapy included taking oral hypoglycemic medications, receiving... | PMC10102335 |
Outcomes | The primary outcome was changes in HbA1c levels from the baseline to the 12-week follow-up measurement. Exploratory outcomes included changes in body weight, waist circumference, body mass index (BMI), positive affect, negative affect, subjective stress, and sleep duration from baseline to the 12-week follow-up. Physic... | PMC10102335 | ||
Sample size calculation | diabetes | DIABETES | A previous study reporting that laughter can decrease HbA1c levels in older adults without diabetes ( | PMC10102335 |
Randomization | After baseline measurements were completed, the participants were stratified according to sex and randomly allocated to either the intervention (laughter yoga program and standard therapy) or control (standard therapy only) group in a 1:1 ratio according to a computer-generated sequence. All randomization was carried o... | PMC10102335 | ||
Statistical analysis | Data were analyzed according to an intention to treat principle, with the baseline value carried forward for missing data. The differences in baseline characteristics between the two groups were tested using independent samples | PMC10102335 | ||
Results | Forty-five eligible participants were enrolled in the study, and 42 agreed to participate in this study and underwent baseline measurements. Twenty-one participants were assigned to the laughter yoga group and 21 participants were assigned to the control group (Consolidated Standards of Reporting Trials (CONSORT) diagr... | PMC10102335 | ||
Discussion | diabetes-related complications, glucose intolerance, insomnia, diabetes | GLUCOSE INTOLERANCE, TYPE 2 DIABETES, DIABETES | The results of this study showed that laughter yoga program for 12 weeks decreased HbA1c levels in individuals with type 2 diabetes. Additionally, the high attendance rate suggests that the program is feasible for the participants. To the best of our knowledge, this is the first randomized controlled trial that has eva... | PMC10102335 |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10102335 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Scientific Ethics Committee of Fukushima Medical University. The patients/participants provided their written informed consent to participate in this study. | PMC10102335 | ||
Author contributions | MH, HIs | MH analyzed and interpreted data, and wrote the manuscript. MH, TO, and YW conducted the study and contributed to data acquisition. TO, EE, KS, HIm, NF, HN, NK, IS, and HIs contributed to the concept and design of the study and participated in critical revision of the manuscript. HN, NK and IS recruited participants an... | PMC10102335 | |
Acknowledgments | The authors are grateful to Ms. Yoshiko Takada (chairperson of the Japanese Laughter Yoga organization), Ms. Seiko Ikegawa, and all other staff for their continuous support of the laughter yoga program. Also, we thank all participants involved and staff at Osaka University Hospital and Osaka University for their assist... | PMC10102335 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10102335 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10102335 | ||
References | PMC10102335 | |||
Background | The Large-scale Assessment of the Key health-promoting Activities of two New mass drug administration regimens with Azithromycin (LAKANA) trial in Mali aims to evaluate the efficacy and safety of azithromycin (AZI) mass drug administration (MDA) to 1–11-month-old infants as well as the impact of the intervention on ant... | PMC10648361 | ||
Methods/design | malaria | MALARIA, SECONDARY | LAKANA is a cluster randomized trial that aims to address the mortality and health impacts of biannual and quarterly AZI MDA. AZI is given to 1–11-month-old infants in a high-mortality setting where a seasonal malaria chemoprevention (SMC) program is in place. The participating villages are randomly assigned to placebo... | PMC10648361 |
Conclusion | SECONDARY | The SAP written prior to data collection completion will help avoid reporting bias and data-driven analysis for the primary and secondary aims of the trial. If there are deviations from the analysis methods described here, they will be described and justified in the publications of the trial results. | PMC10648361 | |
Trial registration | ClinicalTrials.gov ID | PMC10648361 | ||
Keywords | Open access funding provided by Tampere University (including Tampere University Hospital). | PMC10648361 | ||
Background | infection | ADVERSE EVENTS, INFECTION, SECONDARY, INFLAMMATION | Mass drug administration (MDA) of azithromycin (AZI) is a promising strategy for improving child survival in settings with high under five mortality rates (U5MR) [LAKANA stands for Large-scale Assessment of the Key health-promoting Activities of two New mass drug administration regimens with Azithromycin. The primary a... | PMC10648361 |
Trial design | malaria | MALARIA, SECONDARY, STAGGERED | The study is a three-arm cluster randomized, placebo-controlled, double-blinded, parallel-group clinical trial. The trial was designed to estimate the impact of azithromycin on 1–11-month-old infant mortality in Mali, Western Africa, with a sample size of 1151 villages (clusters). The area is covered by a national seas... | PMC10648361 |
Current status of trial | Enrollment for LAKANA began on October 15, 2020, and ended in December 2022. Data collection is ongoing and the last follow-up for the final participants is currently planned to take place in the second half of 2024. We estimate the interim analysis to take place in August 2023. | PMC10648361 | ||
Study objectives | PMC10648361 | |||
Main objective | The main objective of this trial is to determine the impact of a public health intervention program of two-dose (given twice a year, between January and June) or four-dose (given every 3 months) AZI MDA to 1–11-month-old infants on their mortality, when provided in a context of a national SMC program. | PMC10648361 | ||
Secondary objectives | acute infection symptoms, weight gain, malaria | MALARIA, SECONDARY, INTESTINAL INFLAMMATION, MALNUTRITION | In addition to the primary aim, the trial has secondary aims in assessing other health effects of AZI on the treated population. The secondary aims are as follows:To evaluate the effect of receiving two-dose and four-dose AZI MDA on AMR.To evaluate the impact of AZI MDA to 1–11-month-old infants on their period prevale... | PMC10648361 |
Outcomes | PMC10648361 | |||
Primary outcome | death | The primary outcome of the trial will be 1–14-month-old mortality following the 3-month interval after the village has received the AZI MDA or placebo. We record the vital status of village residents as categorical variable with four options: “alive”, “dead”, “moved”, and “unknown”. In the mortality analysis, the numer... | PMC10648361 | |
Secondary outcomes | PMC10648361 | |||
Antimicrobial resistance | We will express AMR as the proportion of The nasopharyngeal and rectal samples will be collected from 4–14-month-old and 49–59-month-old children at the first visit to the village, at 12 months (MDA 5), at 24 months (visit 9), and at 36 months, i.e., 1 year after the last MDA for the villages. We will primarily calcula... | PMC10648361 | ||
Growth and nutritional status | Length-for-age Z-score (LAZ), weight-for-age Z-score (WAZ), weight-for-length Z-score (WLZ), and mid-upper arm circumference Z-score (MUAC-Z) will be calculated using the WHO Child Growth Standards [ | PMC10648361 | ||
Morbidity | malaria, ARI, diarrhea, fever | MALARIA, ACUTE RESPIRATORY INFECTION | Fourteen-day period prevalence of fever with acute respiratory infection (ARI), fever without respiratory symptoms (potential sign of malaria), and diarrhea prior to the visit in children aged 4–14 months will be assessed in each participating cluster (village) from the 59-village subset on each MDA. | PMC10648361 |
Hypotheses | PMC10648361 | |||
Mortality effect | deaths | The hypotheses in terms of mortality effect are as follows:There are fewer deaths per 1000 PYRs among 4–14-month-old infants in clusters where 1–11-month-old-infants are treated with two-dose AZI MDA than in villages where 1–11-month infants are treated with respective placebo.There are fewer deaths per 1000 PYRs among... | PMC10648361 | |
AMR | To evaluate the effect of different MDA frequencies on AMR, we will test 12 hypotheses:Among 4–14-month-old children, the prevalence of AZI-resistant Among 4–14-month-old children, the prevalence of AZI-resistant Among 4–14-month-old children, the prevalence of AZI-resistant Among 4–14-month-old children, the proportio... | PMC10648361 | ||
Morbidity | cough, diarrhea, fever | The specific hypotheses regarding morbidity are the following:Four to 14-month-old children in villages receiving two- or four-dose AZI regimen have lower prevalence of diarrhea within the last 14 days before MDA than same-aged children living in villages receiving placebo.Four to 14-month-old children in villages rece... | PMC10648361 | |
Growth and nutritional status | MUAC-Z | The specific hypotheses regarding growth and nutritional status are as follows:Mean LAZ, WAZ, WLZ, and MUAC-Z measured at 15, 18, 21, and 24 months after village enrollment are higher among 6–8- and 12–14-month-old children in villages that receive two-dose AZI regimen than among same-aged children in villages that rec... | PMC10648361 | |
Mechanisms | malaria, PCR-diagnosed malaria infections | MALARIA | As the investigation into the mechanisms of action of azithromycin centers on the dose-dependent impact at an individual level, specifically the underlying mechanisms of azithromycin’s function following administration, the two treatment arms may be consolidated for analysis. The mechanisms of azithromycin’s action sha... | PMC10648361 |
Statistical methods | PMC10648361 | |||
General principles | SECONDARY | We will analyze the mortality outcome data by the intention-to-treat (ITT) principle, where the ITT population will include all infants of the eligible age at the time of the MDA visit from all the randomized villages according to the treatment the villages were randomized to receive. That is, if the household gives co... | PMC10648361 | |
Analysis of the primary outcome | PMC10648361 | |||
Azithromycin treatment effect on mortality among 1–11-month-old infants | IRD | We will tabulate the mortality (deaths/1000 PYR and absolute numbers) per arm and per 3-month intervals preceding the second to ninth visit. To investigate if azithromycin treatment reduces mortality among 1–11-month-old infants, we will estimate incidence rate ratio (IRR) and its 95% CI to compare the treatment regime... | PMC10648361 | |
Analysis of the secondary outcomes | PMC10648361 | |||
The effect of MDA regimes on AMR | We will present the proportions of children with resistant isolates in at baseline (i.e., MDA 1) and at visit 9 for all the trial arms. We will also produce a table with proportions of resistant isolates from all isolates in the same manner as for children with resistant isolates. To estimate the impact of two- or four... | PMC10648361 | ||
The effect of MDA regimens on morbidity | ARI, diarrhea, fever | REGRESSION | For morbidity analyses, we will calculate the 14-day period prevalence of fever with ARI, fever without respiratory symptoms, and diarrhea in the three intervention arms and perform a three-group comparison using likelihood ratio tests. The latter will be obtained from mixed-effects logistic regression models, with ran... | PMC10648361 |
The effect of MDA regimens on growth and nutritional status | stunting or wasting, wasting, MUAC-Z, stunting | REGRESSION, WASTED, WASTING | We will tabulate the descriptive summaries (mean, SD, min, max) on LAZ, WAZ, WHZ, and MUAC-Z score for each treatment arm. We will analyze the impact of AZI MDA on growth and nutritional status using mixed-effects regression model with identity link and random intercepts for clusters and for children.In addition, we wi... | PMC10648361 |
The effect of MDA regimens on mechanisms of action of azithromycin | malaria, inflammation, parasitemia, parasitaemia, intestinal inflammation | MALARIA, INFLAMMATION, PARASITEMIA, INTESTINAL INFLAMMATION, REGRESSION | Outcomes related to study questions on mechanisms of action of azithromycin are measured twice: at day 0, i.e., before the treatment on the day of fourth MDA visit (9 months after village enrolment), and 14 days after. The two intervention groups will be combined in the analysis. For each endpoint in the mechanistic st... | PMC10648361 |
Subgroup analyses | To examine the effect modification, we will construct different models to test for interaction with pre-defined set of baseline variables. Hypothesis test of difference between groups within each stratum will be performed only if the interaction test gives statistically significant results ( | PMC10648361 | ||
Loss to follow-up and missing data | A participant will be deemed lost to follow-up, if vital status cannot be ascertained in any of the subsequent MDAs. We will present the numbers of loss to follow-up between the three trial arms in the trial flow diagram (Fig. Trial profile | PMC10648361 | ||
Interim analysis | An interim analysis will be conducted when approximately 60% of the target PYR is available. This interim analysis will focus on mortality and SAEs. For this analysis, statistical significance is defined as two-sided If the interim analysis reveals statistically significant mortality difference between the quarterly az... | PMC10648361 | ||
Safety analysis | Written reports of any SAEs will be prepared during the duration of the trial and AEs will be reported as part of the data collection. Types, severity, and relatedness to intervention of the SAEs will be reported. We will not conduct formal group comparisons or statistical inference for the SAEs. | PMC10648361 | ||
Sample size considerations | PMC10648361 | |||
Power-by-simulation approach | STAGGERED | Simulations were conducted to determine the appropriate sample size to achieve target level of power for the main objectives as well as to confirm that the procedures related to the interim analysis will not compromise type I error rate [Mortality among 1–11-month-(29–364 days)-old children in control group of 20 death... | PMC10648361 | |
AMR | The following assumptions were used for the AMR sub-sample size calculations:The AMR sub-sample size is based on the following assumptions.95% AMR prevalence of 12% in the control group for Non-inferiority margin of 10 percent-points in AMR prevalence.80% power, one-sided 2.5% type 1 error rate for each pairwise compar... | PMC10648361 | ||
Statistical software | The analyses will be conducted using Stata statistical software. R programming language will be used for data pre-processing and other analyses if necessary. The used packages and version numbers will be included in the final report. | PMC10648361 | ||
Data management | Data management is described in detail in separate standardized operating procedure (SOP) document as mentioned in the protocol article [ | PMC10648361 | ||
Conclusion | LAKANA will provide valuable information on effect of different MDA strategies on 1–11-month-old mortality and health outcomes in Mali. This article provides details of the statistical analysis strategies planned for the trial data, aiming to reduce the risk of data driven results, as well as reporting bias. Large clus... | PMC10648361 | ||
Acknowledgements | The LAKANA Trial team would like to thank all national and local leaders in Mali who are facilitating trial activities and the children and their families who have participated in the trial to date. The authors gratefully acknowledge the work and dedication of all study staff at all participating sites. The authors tha... | PMC10648361 | ||
Authors’ contributions | All authors adhere to the authorship guidelines of Trials. All authors have agreed to publication. | PMC10648361 | ||
Funding | subawards | Open access funding provided by Tampere University (including Tampere University Hospital). Tampere University has received funding for the proposed trial from the Bill & Melinda Gates Foundation (Seattle, WA, USA). For implementation, Tampere University will issue subawards to CVD-Mali, UCL, and Tro Da Ltd. | PMC10648361 | |
Availability of data and materials | Not applicable. Upon completion of the trial, de-identified data will be made publicly available per the funder, the Bill and Melinda Gates Foundation, policy. | PMC10648361 | ||
Declarations | PMC10648361 | |||
Ethics approval and consent to participate | The trial is conducted in accordance with the International Conference on Harmonization Good Clinical Practice (ICH-GCP) and adheres to the principles of the Helsinki declaration and regulatory guidelines in Mali. LAKANA has received approval from the Mali IRB, the Comité d'Éthique de la Faculté de Médecine, de Pharmac... | PMC10648361 | ||
Consent for publication | Not applicable. | PMC10648361 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10648361 | ||
References | PMC10648361 | |||
Background: | traumas, high disability | DISEASES | Severe multiple traumas are one of the most common diseases and carry a significant financial burden with high disability and mortality. There are no effective drugs in the clinical management of severe multiple traumas, and there is an absence of evidence-based medicine concerning the treatment of severe multiple trau... | PMC9935977 |
Methods: | traumas, infection, UTIs, trauma | MULTIPLE ORGAN DYSFUNCTION SYNDROME, ADVERSE EFFECTS, INFECTION, UTI, INFLAMMATORY RESPONSE | The present study explored whether ulinastatin (UTI) can improve the outcome of severe multiple traumas. The present research included patients who were hospitalized in intensive care units after being diagnosed with severe multiple trauma. Patients received UTIs (400,000 IU) or placebos utilizing computer-based random... | PMC9935977 |
Results: | coagulation dysfunction, infection, UTI, multiple organ dysfunction syndrome, hyperinflammation | INFECTION, MULTIPLE ORGAN DYSFUNCTION SYNDROME, UTI | A total of 239 individuals were classified into 2 groups, namely, the placebo group (n = 120) and the UTI group (n = 119). There were no statistically significant differences in baseline clinical data between the 2 groups. The 30-day mortality and multiple organ dysfunction syndrome in the UTI group were remarkably imp... | PMC9935977 |
Conclusion: | traumas, UTIs | ADVERSE REACTIONS | The findings from the present research indicated that UTIs can improve the clinical outcomes of patients with severe multiple traumas and have fewer adverse reactions. | PMC9935977 |
1. Introduction | death, traumatic brain injury, traumas, posttraumatic hyperinflammation, trauma | UTI | Injuries caused by trauma remain one of the most common causes of death in the world, especially emergency severe multiple traumas combined with traumatic brain injury.Ulinastatin (UTI) is a serine protease inhibitor with a molecular weight of 67,000 that is purified from human urine. The primary pharmacological activi... | PMC9935977 |
2. Methods | PMC9935977 | |||
2.1. Study design | A placebo-controlled, parallel-arm, randomized experiment was carried out in Jiangsu from January 2019 to December 2021. A total of 267 patients were screened over this period, and 239 of these were initially enrolled in the study to form the intention-to-treat population. To determine if the intervention is superior, ... | PMC9935977 | ||
2.2. Patients enrolled in the study and sample selection procedures | allergic, organ dysfunction | MALIGNANT TUMORS, UTI | Patients were included in the present research in the emergency intensive care unit. The following were the criteria for inclusion: patients aged 25 to 70 years; >2 anatomical sites injured and injury severity score ≥ 16; time from injury to hospitalization <12 hours; estimated posttraumatic survival time >72 hours; an... | PMC9935977 |
2.3. Randomization and concealment | EVENT, ACUTE HEPATIC FAILURE | With the aid of SPSS software (version: 14.0) (SPSS Institute, Anhui Medical University, Hefei, China), permuted-block randomization was carried out based on a computer system that used an allotment list to produce random numbers (in a 1-to-1 ratio). This was carried out by a statistician who was not a member of the re... | PMC9935977 | |
2.4. Outcome assessment | MODS, tumor necrosis, infection | MODS, SECONDARY, TUMOR NECROSIS, INFECTION | All clinical and imaging data and treatment were subjected to assessment by a masked independent diagnostic and assessment committee. This committee included 2 researchers who were trained before the start of the present research and did not engage in the clinical care of patients. The primary endpoint of this study wa... | PMC9935977 |
2.5. Safety evaluation and complications | diarrhea, Abnormal liver enzymes, vomiting, abnormal liver, granulocytopenia, allergies, UTIs | ADVERSE EFFECTS, ALLERGIES, COMPLICATIONS, GRANULOCYTOPENIA | We kept track of the length of time spent in the intensive care unit, and the most prevalent adverse effects of UTIs included granulocytopenia and abnormal liver enzymes. Other rare complications include diarrhea, vomiting, and allergies. All complications were confirmed and recorded by physical examination after 2 doc... | PMC9935977 |
2.6. Postoperative hospital stays and hospitalization costs | traumas | As previously reported, severe multiple traumas or critical care patients have remarkably longer hospital stays and higher hospitalization expenses. Thus, the present research examined the difference in the overall duration of hospital stay and healthcare costs among patients belonging to the 2 groups. | PMC9935977 | |
2.7. Sample size estimates | In a previous study, | PMC9935977 | ||
2.8. Statistical analysis | Data from the baseline as well as outcome assessments were input into the database by a research nurse. The information was gathered on handwritten forms and stored in a digital database that was password secured. All continuous variables are presented as the mean ± SD. SPSS 19.0 statistical software (SPSS, Inc., Chica... | PMC9935977 | ||
3. Results | blindness | BLINDNESS, UTI | A total of 267 patients were evaluated between January 2019 and December 2021, and 239 of these were initially enrolled in the study to form the intention-to-treat population, which was given UTI (n = 120) or placebo (n = 119) treatment in a random manner. There were no cases of open blindness observed throughout the r... | PMC9935977 |
3.1. The primary endpoint and risk of MODS | MODS | MODS, MULTIPLE ORGAN DYSFUNCTION SYNDROME, UTI | After treatment, the total 30-day mortality was 16.74% (40/239), according to the findings. The 30-day mortality was 15.38% (14/120) in the UTI group and 28.89% (26/119) in the placebo control group. As opposed to the UTI group, the placebo group exhibited a remarkably greater 30-day mortality rate, with a significant ... | PMC9935977 |
3.2. The secondary endpoints | infection, tumor necrosis | PCT, TUMOR NECROSIS, INFECTION, SECONDARY, UTI | Before UTI or placebo treatment, there was no significant difference in the inflammatory cytokine levels, coagulation function, serum infection index levels, liver function index levels, or renal function index levels between the 2 groups (Comparison of the secondary end-points.ALT = alanine aminotransferase, APTT = ac... | PMC9935977 |
3.3. Safety evaluation | abnormal liver enzymes, abnormal liver, granulocytopenia | ADVERSE EFFECTS, GRANULOCYTOPENIA, UTI | The most prevalent adverse effects of UTI include granulocytopenia and abnormal liver enzymes. We found that 10 (8.33%) patients experienced granulocytopenia in the UTI group, while 6 (5.04%) patients experienced granulocytopenia in the placebo group, with no significant difference between the 2 groups. There were 21 (... | PMC9935977 |
3.4. Postoperative hospital stays and hospitalization costs | UTI | In the UTI group, the average duration of stay was 28.64 days, whereas the value for the placebo group was 29.41 days, with no statistically significant difference ( | PMC9935977 | |
4. Discussion | MODS, toxic shock, coagulation dysfunction, abnormal liver, infection, allergies, hyperinflammation, sepsis, trauma | TOXIC SHOCK, INFLAMMATORY DISORDER, MODS, INFECTION, ADVERSE EFFECTS, HEMORRHAGIC SHOCK, UTI, ALLERGIES, SEPSIS | According to the findings of the current investigation, UTI may greatly reduce the incidence of total 30-day mortality and MODS in emergency severe multiple trauma patients. Additionally, we also found that UTI can protect against hyperinflammation and improve coagulation dysfunction, infection, liver function, and ren... | PMC9935977 |
5. Conclusion | MODS, traumas, coagulation dysfunction, infection, hyperinflammation, UTIs, trauma | MODS, INFECTION, UTI | The findings of the present research suggest that UTI treatment may help to minimize the risk of mortality and MODS against hyperinflammation and improve coagulation dysfunction, infection, liver function, and renal function following severe multiple traumas. Furthermore, it resulted in a considerable reduction in hosp... | PMC9935977 |
Acknowledgments | We hereby express our gratitude to Jiangsu Brilliant Biological Technology Co., Ltd. for providing technical and linguistic help. | PMC9935977 | ||
Abbreviations: | fibrinogenmultiple organ dysfunction, trauma | fibrinogenmultiple organ dysfunction syndromemultiorgan failureulinastatinThe authors have no funding to disclose.The authors have no conflicts of interest to disclose.The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.How to cite thi... | PMC9935977 | |
References | PMC9935977 | |||
Supplementary Information | cardiovascular arrythmias | Plasma potassium (p-K) in the high-normal range has been suggested to reduce risk of cardiovascular arrythmias and mortality through electrophysiological and mechanical effects on the myocardium. In this study, it was to investigated if increasing p-K to high-normal levels improves systolic- and diastolic myocardial fu... | PMC10673982 | |
Keywords | Open access funding provided by Royal Library, Copenhagen University Library | PMC10673982 | ||
Introduction | heart failure, systolic dysfunction | HEART FAILURE, SYSTOLIC DYSFUNCTION | Low as well as high plasma-potassium (p-K) levels have been shown to be associated with reduced survival [Myocardial function at low p-K levels has been studied experimentally in dogs (n = 27) and in healthy human volunteers (n = 10) [2D-speckle tracking echocardiography has been demonstrated to be a sensitive and robu... | PMC10673982 |
Materials and methods | PMC10673982 | |||
Population | heart failure | MAY, EVENTS, HEART FAILURE | The current substudy was prespecified in the protocol for the For the present study, 50 consecutive patients from the POTCAST trial with LVEF between 35 and 55% were included between June 1, 2020 and May 31, 2021. Patients were excluded from the final analysis if any of the following criteria were present: echocardiogr... | PMC10673982 |
Ethics | The study was performed according to the declaration of Helsinki. All patients provided informed consent. The study was approved by regional Danish committee of health research ethics (Regional Videnskabsetisk komité) — Protocol approval no. H-18,044,908 and by the Danish Data Protection Agency — approval no. VD-2018-4... | PMC10673982 | ||
Intervention | Patients in the control group continued standard medical treatment. In addition to the standard treatment patients in the intervention group were educated in intake of a potassium rich diet and commenced oral potassium supplement and/or MRA (spironolactone or eplerenone) according to the POTCAST protocol [ | PMC10673982 | ||
Screening and follow-up | Transthoracic echocardiography was performed at enrollment after measurements of p-K | PMC10673982 | ||
Echocardiography | All echocardiographies were performed by a single investigator using the same ultrasound system (Vivid E9, GE healthcare), the same probe (M5S-D, GE) and the same analyzing software (EchoPac, version 203.66). Cine loops from 3 standard apical views (2-chamber, 4-chamber, and apical long-axis) were recorded using gray-s... | PMC10673982 | ||
Outcomes | The predefined outcomes were differences in changes from baseline to follow-up between the two groups in 2D-speckle tracking derived indices of systolic function: GLS, MD and for assessment of diastolic function: E/A, e´ and E/e´. | PMC10673982 | ||
Sensitivity analysis | A subgroup analysis was performed on patients in the intervention group that only received dietary guidance and potassium as a supplement to reach target p-K levels to test if the effects of increasing potassium levels on myocardial function was independent of the effects of MRA on loading conditions. | PMC10673982 |
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