Heart Failure With Reduced Ejection Fraction Polypill Implementation Strategy in Sri Lanka
1 other identifier
interventional
40
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2025
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2024
CompletedStudy Start
First participant enrolled
February 15, 2025
CompletedFirst Posted
Study publicly available on registry
February 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2025
CompletedMay 8, 2025
May 1, 2025
3 months
April 10, 2024
May 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility of recruitment
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
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 Outcomes (6)
Adherence to overall and individual components of GDMT
4 weeks
Withdrawals due to Adverse Events
From enrollment to the end of treatment at 4 weeks
Serious Adverse Events
From enrollment to the end of treatment at 4 weeks
Adverse Events of Special Interest
From enrollment to the end of treatment at 4 weeks
Mean Change in Serum Potassium
4 weeks
- +1 more secondary outcomes
Study Arms (2)
Comparator (control) arm
OTHERParticipants in the comparator control arm will receive usual care, as per their physician's discretion.
Study Intervention arm
EXPERIMENTALParticipants in the intervention group will be provided the HFrEF polypill by the study.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- The George Institutecollaborator
- RemediumOnecollaborator
- Centre for Chronic Disease Control, Indiacollaborator
Study Sites (2)
National Hospital of Sri Lanka
Colombo, 00700, Sri Lanka
Colombo South Teaching Hospital
Colombo, 10350, Sri Lanka
Related Publications (1)
Agarwal A, de Silva A, Agarwal M, Ajanthan S, Dahanayaka A, Dhurjati R, Fernando C, Galappatthy G, Goss CW, Hively A, Jayagopal PB, Mohanan PP, Patel A, Prabhakaran D, Rahuman M, Rodgers A, Roberts K, Salwa H, Huffman MD, Salam A. Heart failure with reduced ejection fraction polypill implementation strategy in Sri Lanka: design and protocol of a pilot type I hybrid randomised clinical trial. BMJ Open. 2025 Jul 15;15(7):e100952. doi: 10.1136/bmjopen-2025-100952.
PMID: 40664424DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2024
First Posted
February 18, 2025
Study Start
February 15, 2025
Primary Completion
May 5, 2025
Study Completion
May 5, 2025
Last Updated
May 8, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
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.