Heart Failure With Reduced Ejection Fraction Polypill Implementation Strategy in Sri Lanka

May 7, 2025 updated by: Washington University School of Medicine

Heart Failure With Reduced Ejection Fraction Polypill Implementation Strategy in Sri Lanka: A Pilot Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sri Lanka
      • Colombo, Sri Lanka, 10350
        • Colombo South Teaching Hospital
      • Colombo 10, Sri Lanka, 00700
        • National Hospital of Sri Lanka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Known contraindication to any of the HFrEF polypill components (e.g., advanced renal disease, bradycardia, allergy, amongst others).
  • Significant renal impairment (estimated glomerular filtration rate <=30 mL/min/1.73 m2 or creatinine clearance <=30mL/min).
  • Raised serum potassium >5 mEq/L.
  • Symptomatic hypotension or systolic BP <100 mmHg as per the average of last 2 of the 3 measurements at visit 1.
  • Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1.
  • Cardiogenic shock and/or current use of inotropes.
  • Myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrollment.
  • 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).
  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Comparator (control) arm
Participants in the comparator control arm will receive usual care, as per their physician's discretion.
Other: Comparator Arm
Participants in the comparator control group will receive usual care by their healthcare providers. Providers will be encouraged to treat all participants according to international and local clinical practice guidelines.
Experimental: Study Intervention arm
Participants in the intervention group will be provided the HFrEF polypill by the study.
Drug: HFrEF Polypill

The heart failure with reduced ejection fraction (HFrEF) polypill will include 4 guideline recommended medications used to treat HFrEF patients. The dose of initiation and titration will be at the investigator's discretion.

HFrEF polypill strength 1: bisoprolol 2.5 mg + losartan 25 mg + eplerenone 25 mg + dapagliflozin 10 mg; HFrEF polypill strength 2: bisoprolol 5 mg + losartan 50 mg + eplerenone 25 mg + dapagliflozin 10 mg; HFrEF polypill strength 3: bisoprolol 10 mg + losartan 100 + eplerenone 50 mg + dapagliflozin 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of recruitment
Time Frame: 0 - 10 weeks, start of enrollment to completion of participant enrollment
Feasibility of recruitment based on completion of the following: recruitment of up to 40 participants at a rate of 4 participants per week.
0 - 10 weeks, start of enrollment to completion of participant enrollment
Adherence to study procedures
Time Frame: 0 - 14 weeks, baseline to study end
Adherence to study procedures based on completion of the following: completion of study-related procedures (screening, randomization, study drug allocation, follow-up procedures, retention, and outpatient transition).
0 - 14 weeks, baseline to study end

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to overall and individual components of GDMT
Time Frame: 4 weeks
The secondary outcome is the proportion of individuals with adherence to overall and individual components of GDMT (ACE-I or ARB or ARNi, BB, MRA, and SGLT2i use at any dose in the absence of contraindications) at 4 weeks measured by 1) pill count, and 2) the self-report tool Medication Adherence Report Scale (MARS-5).
4 weeks
Withdrawals due to Adverse Events
Time Frame: From enrollment to the end of treatment at 4 weeks
Proportion of withdrawals due to adverse events.
From enrollment to the end of treatment at 4 weeks
Serious Adverse Events
Time Frame: From enrollment to the end of treatment at 4 weeks
Proportion of participants with any serious adverse events (SAEs) according to the Good Clinical Practice (GCP) definition.
From enrollment to the end of treatment at 4 weeks
Adverse Events of Special Interest
Time Frame: From enrollment to the end of treatment at 4 weeks
Proportion of participants with adverse events of special interest (diabetic ketoacidosis, volume depletion [hypotension, syncope, orthostatic hypotension or dehydration all defined clinically], severe hypoglycemic event, lower limb amputation, hyperkalemia, worsening renal function)
From enrollment to the end of treatment at 4 weeks
Mean Change in Serum Potassium
Time Frame: 4 weeks
Mean change (from baseline) in continuous serum potassium, controlling for baseline value.
4 weeks
Change in Serum Creatinine
Time Frame: 4 weeks
Mean change (from baseline) in serum creatinine, controlling for baseline value.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Centre for Chronic Disease Control, India
The George Institute for Global Health, India
RemediumOne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2025

Primary Completion (Actual)

May 5, 2025

Study Completion (Actual)

May 5, 2025

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202306038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

When the study is over, research findings will be available at www.ClinicalTrials.gov and Sri Lanka Clinical Trials Registry. Laboratory results will be shared with participants and their health care providers. The research findings will also be published in the form of research articles or presented at scientific meetings.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe