NCT06831864CompletedPhase 1
Heart Failure With Reduced Ejection Fraction Polypill Implementation Strategy in Sri Lanka
Heart Failure With Reduced Ejection Fraction Polypill Implementation Strategy in Sri Lanka: A Pilot Randomized Trial
Source: ClinicalTrials.gov · Last updated 8 May 2025
Brief summary (registry, in English)
The primary objective of this trial is to see if the research team can successfully recruit participants and carry out study related procedures in Sri Lanka. This will help the research team plan and execute a future large-scale trial in Sri Lanka. The secondary objective is to assess whether a polypill for patients with heart failure with reduced ejection fraction (a type of heart condition) may help patients adhere to medications without an increase in serious adverse events. An exploratory objective is to understand the process of implementation. Participants will be randomly assigned to one of two groups, intervention or usual care. The intervention group will be given four guideline-recommended medications for heart failure with reduced ejection fraction, combined in one over-encapsulated pill, with three dose strength options (at the discretion of their treating physician). Both groups will be observed over 4-weeks of follow-up to assess their medication adherence, clinical symptoms, laboratory measures, health related quality of life, and need for medication adjustment amongst other measures.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 10 Apr 2024
- Start date
- 15 Feb 2025
- Primary completion date
- 5 May 2025
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Heart failure
- NCT number
- NCT06831864
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 40
- From 15 Feb 2025 to the primary completion date, 5 May 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrollment.
- Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary physician could interfere with the conduct of the study including outcome assessment.
- Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.
Other illness
- Known contraindication to any of the HFrEF polypill components (e.g., advanced renal disease, bradycardia, allergy, amongst others).
- Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1.
Lab values
- Significant renal impairment (estimated glomerular filtration rate \<=30 mL/min/1.73 m2 or creatinine clearance \<=30mL/min).
- Raised serum potassium \>5 mEq/L.
Other
- Symptomatic hypotension or systolic BP \<100 mmHg as per the average of last 2 of the 3 measurements at visit 1.
- Cardiogenic shock and/or current use of inotropes.
- Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).
- Participant's responsible physician believes it is not appropriate for participant to participate in the study.
- Inability or unwillingness to provide written informed consent.
- Involvement in the planning and/or conduct of the study.
- Unable to complete study procedures and/or plan to move out of the study site area in the next 2 months.
Who the study is looking for
- Adults (age ≥18 years old)
- Diagnosis of heart failure with reduced ejection fraction (HFrEF) including clinical symptoms or clinical signs or natriuretic peptide elevation AND echocardiographic or other evidence of reduced ejection fraction (EF 40%)
- New York Heart Association Class II, III, or IV symptoms
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Colombo South Teaching Hospital Coordinator of this site? Confirm its status | Colombo | Sri Lanka | Unknown status |
| National Hospital of Sri Lanka Coordinator of this site? Confirm its status | Colombo | Sri Lanka | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.