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Completed

NCT Number: NCT06831864

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

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.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Colombo South Teaching Hospital, Colombo, Sri Lanka

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HFrEF Polypill

Drug

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

Comparator arm

Other

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.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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).

  2. Withdrawals due to Adverse Events

    Time frame: From enrollment to the end of treatment at 4 weeks

    Proportion of withdrawals due to adverse events.

  3. 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.

  4. 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)

  5. Mean Change in Serum Potassium

    Time frame: 4 weeks

    Mean change (from baseline) in continuous serum potassium, controlling for baseline value.

  6. Change in Serum Creatinine

    Time frame: 4 weeks

    Mean change (from baseline) in serum creatinine, controlling for baseline value.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Centre for Chronic Disease Control, India
  • RemediumOne
  • The George Institute

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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