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HFrEF Polypill in Sri Lanka RCT

14 maggio 2026 aggiornato da: Washington University School of Medicine

Heart Failure With Reduced Ejection Fraction Polypill in Sri Lanka: A Multi-Center Type I Hybrid Randomized Controlled Trial

Primary Outcome:

Composite of cardiovascular death or recurrent heart failure hospitalization over study duration

Secondary Outcomes:

Cardiovascular death over study duration Recurrent heart failure hospitalizations over study duration All-cause mortality over study duration Change in left ventricular ejection fraction from baseline to 12 months by echocardiogram.

Change in natriuretic peptide levels from baseline to 12 months. Change in health-related quality of life from baseline to 12 months using the Kansas City Cardiomyopathy Questionnaire.

Change in New York Heart Association functional class from baseline to 12 months.

Adherence to heart failure medications assessed by pill count and questionnaire, medication persistence assessed as continuation of assigned therapy after initiation, and dose optimization assessed as proportion achieving final/target doses over study duration

Safety Outcomes:

Proportion of participants with serious adverse events or sudden unexpected serious adverse reaction over study duration Proportion with adverse events of special interest (symptomatic hypotension, diabetic ketoacidosis, severe hypoglycemia, lower limb amputation, hyperkalemia, or worsening kidney function) over study duration Proportion of participants who stop study drug because of adverse events over study duration Change in serum potassium over study duration Change in serum creatinine over study duration

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 a minimum of 12-months 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study intervention will be a heart failure with reduced ejection fraction (HFrEF) polypill consisting of bisoprolol (beta-blocker), losartan (ARB), eplerenone (MRA), and dapagliflozin (SGLT2i) manufactured using the over-encapsulation method and will undergo extensive stability testing to ensure quality. There will be 3 strengths of the HFrEF polypill available to facilitate initiation with low dose to prioritize clinical tolerability and laboratory safety and titration to higher doses of the HFrEF polypill. The dose of initiation and titration will be at the investigator's discretion. The HFrEF polypill will be delivered by licensed physicians responsible for managing heart failure at participating sites. Eligible providers must have formal medical qualifications in Sri Lanka and be actively involved in the care of patients with HFrEF. This includes cardiologists, internists, or general practitioners with experience in heart failure management. All participating physicians will receive standardized training on the study protocol including titration protocol, HFrEF polypill composition, and guidance for patient counseling prior to trial initiation to ensure consistent and accurate delivery of the intervention. Participants receiving the HFrEF polypill will also receive a "HFrEF polypill card" that delineates the drugs and doses included in the HFrEF polypill combination and contact information for the local study team in case of hospitalization at another facility.

HFrEF polypill combinations by strength:

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 from their healthcare providers. Providers will be encouraged to treat all participants according to international and local clinical practice guidelines. Participants in the intervention group will be provided with the HFrEF polypill by the study, and participants in the control group will be provided HFrEF medications through the pharmacy at the public hospital site(s) in Sri Lanka where they are generally free of cost.

Tipo di studio

Interventistico

Iscrizione (Stimato)

1656

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Anubha Agarwal, MD MSc
  • Numero di telefono: 314-362-1291
  • Email: anubha@wustl.edu

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Adults (≥18 years old)
  2. 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%)
  3. New York Heart Association Class II, III, or IV symptoms

Exclusion Criteria:

  1. Known contraindication to any of the HFrEF polypill components (e.g., advanced renal disease, bradycardia, allergy, amongst others).
  2. Significant renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m2)
  3. Raised serum potassium >5 mEq/L.
  4. Symptomatic hypotension or systolic BP <100 mmHg as per the average of last 2 of the 3 measurements at visit 1.
  5. Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1.
  6. History of type 1 diabetes mellitus.
  7. 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).
  8. 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.
  9. 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.
  10. Participant's responsible physician believes it is not appropriate for participant to participate in the study.
  11. Inability or unwillingness to provide written informed consent.
  12. Involvement in the planning and/or conduct of the study.
  13. Unable to complete study procedures and/or plan to move out of the study site area in the next 2 months.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Braccio di intervento di studio
Ai partecipanti al gruppo di intervento verrà fornito dall'HFREF Polypill dallo studio.
Droga: Hfref Polypill

L'insufficienza cardiaca con il polipill di frazione di eiezione ridotta (HFREF) includerà 4 linee guida per il trattamento dei pazienti HFREF. La dose di iniziazione e titolazione sarà a discrezione dell'investigatore.

Hfref Polypill Restendtion 1: bisoprololo 2,5 mg + losartan 25 mg + eplerenone 25 mg + dapagliflozin 10 mg; Hfref Polypill Restendtion 2: bisoprololo 5 mg + losartan 50 mg + eplerenone 25 mg + dapagliflozin 10 mg; Hfref Polypill Restendtion 3: bisoprololo 10 mg + losartan 100 + eplerenone 50 mg + dapagliflozin 10 mg
Comparatore attivo: Control arm
Participants in the comparator control arm will receive usual care, as per their physician's discretion.
Altro: Braccio comparatore
I partecipanti al gruppo di controllo del comparatore riceveranno cure abituali dai loro operatori sanitari. I fornitori saranno incoraggiati a trattare tutti i partecipanti in base alle linee guida di pratica clinica internazionale e locale.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Composite rate of cardiovascular disease mortality and recurrent HF hospitalizations
Lasso di tempo: 1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.

Cardiovascular disease mortality is defined as death due to acute myocardial infarction, worsening heart failure, stroke, sudden cardiac death, arrhythmia, pulmonary embolism, cardiovascular procedures, vascular causes, or any death of unknown cause unless a non-cardiovascular etiology is clearly established.

Recurrent HF hospitalizations is defined as any hospitalization in which the primary cause is worsening heart failure, accompanied by objective evidence of decompensation and requiring initiation or intensification of HF-specific therapy, occurring after a documented period of clinical stability of at least 12 hours since the prior HF event.

Adjudicated by the blinded Outcome Adjudication Committee.
1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rate of cardiovascular disease mortality
Lasso di tempo: 1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.

Cardiovascular disease mortality is defined as death due to acute myocardial infarction, worsening heart failure, stroke, sudden cardiac death, arrhythmia, pulmonary embolism, cardiovascular procedures, vascular causes, or any death of unknown cause unless a non-cardiovascular etiology is clearly established.

Adjudicated by the blinded Outcome Adjudication Committee.
1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
Rate of recurrent heart failure hospitalizations
Lasso di tempo: 1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.

Recurrent HF hospitalizations is defined as any hospitalization in which the primary cause is worsening heart failure, accompanied by objective evidence of decompensation and requiring initiation or intensification of HF-specific therapy, occurring after a documented period of clinical stability of at least 12 hours since the prior HF event.

Adjudicated by the blinded Outcome Adjudication Committee.
1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
Rate of all-cause mortality
Lasso di tempo: 1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
All-cause mortality is defined as death due to any cause.
1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
Change in left ventricular ejection fraction
Lasso di tempo: Baseline, 12 months
How much the heart's pumping ability changes over one year, measured using a heart ultrasound test (echocardiogram).
Baseline, 12 months
Natriuretic peptide levels change
Lasso di tempo: Baseline, 12 months
Change in a blood test that reflects heart stress using a validated commercially available immunoassay (i.e., BNP) from baseline to 12 months.
Baseline, 12 months
Change in overall and domain specific health-related quality of life
Lasso di tempo: Baseline, 12 months
Health-related quality of life (HRQoL) will be assessed using a validated, translated Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23). The KCCQ-23 measures overall and domain-specific HRQoL, including physical limitation, symptom frequency and impact, quality of life, and social limitation. Scores are transformed to a 0-100 scale, with higher scores indicating better health status; change from baseline to 12 months will be analyzed for overall and domain-specific scores. Overall summary score will be used as a secondary outcome. Domain-specific scores will be considered exploratory.
Baseline, 12 months
Physician-reported New York Heart Association class change
Lasso di tempo: Baseline, 12 months
Change in how severe heart failure symptoms are over 12 months, as rated by the doctor (New York Heart Association class).
Baseline, 12 months
Adherence to guideline-directed medical therapy
Lasso di tempo: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Medication adherence assessed by pill count.
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Adherence to Guideline-Directed Medical Therapy
Lasso di tempo: Baseline, 1 month, 3 month, 6 month, 9 month, 12 month
Medication adherence assessed by MARS-5 questionnaire
Baseline, 1 month, 3 month, 6 month, 9 month, 12 month
Persistence to Guideline-Directed Medical Therapy
Lasso di tempo: Baseline, 1 month, 3 month, 6 month, 9 month, 12 month
Medication persistence assessed as continuation of assigned therapy after initiation
Baseline, 1 month, 3 month, 6 month, 9 month, 12 month
Optimization of Guideline-Directed Medical Therapy
Lasso di tempo: 6 and 12 months
Dose optimization assessed as proportion achieving final/target doses
6 and 12 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Serious adverse events or sudden unexpected serious adverse reaction
Lasso di tempo: 1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
Proportion of participants with serious adverse events or sudden unexpected serious adverse reaction according to the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines (ICH E6 [R3]) over the study duration.
1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
Adverse Events of Special Interest
Lasso di tempo: 1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
Adverse events of special interest defined as: a) symptomatic hypotension defined as systolic blood pressure < 90 mmHg and associated symptoms of light-headedness, dizziness, or pre-syncope, b) diabetic ketoacidosis, c) severe hypoglycemic event, d) lower limb amputation, e) hyperkalemia defined as serum potassium greater than or equal to 5.5 mEq/L, and f) worsening renal function defined as ≥50% increase in serum creatinine or at a lower threshold per physician judgement.
1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
Adverse events leading to study drug discontinuation
Lasso di tempo: 1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
Number of participants who stop the study medication because of side effects during the study.
1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
Serum potassium (mEq/L) change
Lasso di tempo: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
Mean (average) change in serum potassium levels over study duration
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
Serum creatinine (mg/dL) change
Lasso di tempo: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.
Mean (average) change in a serum creatinine over study duration
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, through study completion, an average of 18 months.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Washington University School of Medicine

Collaboratori

National Heart, Lung, and Blood Institute (NHLBI)
Centre for Chronic Disease Control, India
The George Institute
RemediumOne

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 dicembre 2028

Completamento dello studio (Stimato)

1 marzo 2029

Date di iscrizione allo studio

Primo inviato

11 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 maggio 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 202605087

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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