Home » Trials » SLCTR/2024/003
Heart Failure with Reduced Ejection Fraction Polypill Implementation Strategy in South Asia: A Pilot Randomized Trial
-
SLCTR Registration Number
SLCTR/2024/003
Date of Registration
The date of last modification
Feb 14, 2024
Scientific Title of Trial
Heart Failure with Reduced Ejection Fraction Polypill Implementation Strategy in South Asia: A Pilot Randomized Trial
Public Title of Trial
A Pilot Randomized Trial Evaluating the Feasibility and Safety of a Polypill Implementation Strategy in Patients with Heart Failure with Reduced Ejection Fraction in South Asia
Disease or Health Condition(s) Studied
Heart failure with reduced ejection fraction
Scientific Acronym
None
Public Acronym
HFrEF polypill trial
Brief title
None
Universal Trial Number
U1111-1298-9994
Any other number(s) assigned to the trial and issuing authority
P/111/08/2023; Faculty of Medicine, University of Kelaniya
What is the research question being addressed?
Is the study design feasible to assess the efficacy, safety and enhance adherence to guideline-directed medical therapy (GDMT) of the HFrEF polypill strategy, compared to standard of care for HFrEF patients in South Asia?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study sites: The National Hospital of Sri Lanka and Colombo South Teaching Hospital.
Intervention: The study intervention will be a HFrEF polypill consisting of a Beta Blocker (BB), an Angiotensin receptor blocker (ARB), an mineralocorticoid receptor antagonist (MRA), and a Sodium-glucose cotransporter-2 inhibitor (SGLT2i) manufactured using the over-encapsulation method. The HFrEF polypill will be manufactured in 3 strengths to facilitate initiation with half-dose to prioritize clinical tolerability and laboratory safety and titration to a full-dose and double-dose HFrEF polypill. The dose of initiation and titration will be at the investigator’s discretion based on the clinical history and laboratory assessments.
Proposed HFrEF polypill combination, initiation, and titration schedule:
HFrEF polypill 1 (half-dose): bisoprolol 1.25 mg + losartan 50 mg + eplerenone 25 mg + dapagliflozin 10 mg
HFrEF polypill 2 (Full-dose): bisoprolol 5 mg + losartan 100 mg + eplerenone 25 mg + dapagliflozin 10 mg
HFrEF polypill 3 (Double-dose): bisoprolol 10 mg + losartan 150 + eplerenone 50 mg + dapagliflozin 10 mg
Randomization will be done through a randomization list for equal allocation (1:1) to intervention arm and comparator arm through the electronic data capturing system REDCap. Participants in the control arm will receive the standard of care by their healthcare providers. Healthcare providers will be encouraged to treat all participants according to international and local clinical practice guidelines. Participants in the intervention arm will be provided the HFrEF polypill by the study. One week after starting study medication, participants’ clinical symptoms, vital signs, medication adherence, laboratory measures, and need for medication adjustment/up-titration will be evaluated.
Four weeks after starting study medication, participants’ clinical symptoms, vital signs, laboratory measures, health related quality of life and need for medication adjustment (including transitioning back to original HFrEF outpatient medication regimen) will be evaluated.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
1.Feasibility of recruitment and adherence to study protocols based on completion of Recruitment of up to 80 participants at a rate of 4 participants per week. |
[ At end of participant recruitment for the study ] |
2.
2.Feasibility of recruitment and adherence to study protocols based on completion of study related procedures (screening, randomization, study drug allocation, follow-up procedures, retention, and outpatient transition) |
[ Week 4 ] |
3.
3.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) measured by pill count and self-report using structured questionnaire [in-house] |
[ Week 4 ] |
Secondary outcome(s)
1.
Proportion of participants with any serious adverse events (SAEs) according to the Good Clinical Practice (GCP) definition |
[ Week 1, Week 4 ] |
2.
Proportion of participants with adverse events of special interest (AESIs) which are hyperkalemia, worsening renal function, and hypotension. |
[ Week 1, Week 4 ] |
3.
Proportion of withdrawals due to adverse events |
[ Week 4 ] |
4.
Mean change (from baseline) in continuous serum potassium (mEq/L), controlling for baseline value |
[ Baseline, Week 1, Week 4 ] |
5.
Mean change (from baseline) in continuous serum creatinine (mg/dL), controlling for baseline value |
[ Baseline, Week 1, Week 4 ] |
6.
Change in B-type natriuretic peptide (BNP) |
[ Baseline, Week 4 ] |
7.
Change in physician reported New York Heart Association (NYHA) functional class |
[ Baseline, Week 1, Week 4 ] |
8.
Change in health-related quality of life |
[ Baseline, Week 4 ] |
9.
Rate of HF hospitalization |
[ Baseline, Week 1, Week 4 ] |
10.
Rate of cardiovascular disease mortality |
[ Baseline, Week 1, Week 4 ] |
Target number/sample size
40 (20 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2024-04-01
Anticipated end date
2024-07-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Washington University in St. Louis 1 Brookings Drive, St. Louis, MO 63130 United States
Regulatory approvals
Approved
Status
Approved
Date of Approval
2023-09-29
Approval number
P/111/08/2023
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
Institutional Address: | P.O Box 6, Thalagolla Road, Ragama, Sri Lanka |
Telephone: | +94 11 2961267 |
Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr. Gotabhaya Ranasinghe
General and Interventional Cardiologist
Institute of Cardiology, National Hospital of Sri Lanka, Colombo 10
+94 112 691 111
+94 77 731 9143
gotabhayar@gmail.com
Contact Person for Public Queries
Dr. Gotabhaya Ranasinghe
General and Interventional Cardiologist
Institute of Cardiology, National Hospital of Sri Lanka, Colombo 10
+94 112 691 111
gotabhayar@gmail.com
Primary study sponsor/organization
Washington University in St. Louis
1 Brookings Drive, St. Louis, MO 63130
United States
https://wustl.edu.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results