AzTrials
AzTrials

Heart Failure With Reduced Ejection FractionPhase 1NCT06831864

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

A Phase 1 study testing HFrEF Polypill and Comparator Arm in people with Heart Failure With Reduced Ejection Fraction, run by Washington University School of Medicine at 2 sites in Sri Lanka.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HFrEF Polypill and Comparator Arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesSri Lanka
Study dates
15 Feb 2025to 5 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Sri Lanka2 sites

  • National Hospital of Sri Lanka

    Colombo, 00700

  • Colombo South Teaching Hospital

    Colombo, 10350

Other trials in Sri Lanka

About this study

Official title: 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.

Read more

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.

Being tested
HFrEF Polypill, Comparator Arm
Keywords
HFrEF, Heart Failure, Heart Failure with Reduced Ejection Fraction, Sri Lanka, Polypill
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HFrEF PolypillDrug

    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 ArmOther

    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.

Study groups in NCT06831864
Study groupRoleWhat they receive
Comparator (control) armOtherParticipants in the comparator control arm will receive usual care, as per their physician's discretion.
Receives: Other: Comparator Arm
Study Intervention armExperimentalParticipants in the intervention group will be provided the HFrEF polypill by the study.
Receives: Drug: HFrEF Polypill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0 - 10 weeks, start of enrollment to completion of participant enrollment

  2. 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).

    Measured: 0 - 14 weeks, baseline to study end

Secondary outcomes (6)

  1. Adherence to overall and individual components of GDMT

    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).

    Measured: 4 weeks

  2. Withdrawals due to Adverse Events

    Proportion of withdrawals due to adverse events.

    Measured: From enrollment to the end of treatment at 4 weeks

  3. Serious Adverse Events

    Proportion of participants with any serious adverse events (SAEs) according to the Good Clinical Practice (GCP) definition.

    Measured: From enrollment to the end of treatment at 4 weeks

  4. Adverse Events of Special Interest

    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)

    Measured: From enrollment to the end of treatment at 4 weeks

  5. Mean Change in Serum Potassium

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

    Measured: 4 weeks

  6. Change in Serum Creatinine

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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start15 Feb 2025
  3. Primary completion5 May 2025
  4. Study completion5 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06831864
Sponsor's protocol ID
202306038
Status last verified
May 2025
First submitted
10 Apr 2024
Last updated
8 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 40664424

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HFrEF Polypill and Comparator Arm in people with Heart Failure With Reduced Ejection Fraction, run by Washington University School of Medicine at 2 sites in Sri Lanka.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of recruitment (time frame: 0 - 10 weeks, start of enrollment to completion of participant enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06831864, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in