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Optimal PharmacoTherapy and Invasive Management of Atrial Fibrillation in Patients With Heart Failure

Study acronym: OPTIMal AF-HF
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Notable Primary endpoint(s) modified Show 8 more changesShow less
    • Phase changed: Phase 4 → Phase 3
    • Start date: Dec 1, 2025 to Nov 1, 2026
    • Interventions modified
    • Trial arms changed: 3 → 2
    • Enrollment target: 1056 to 1050
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints: 12 to 14
    • Study title shortened, about 3 words
  2. Minor Study title expanded, about 6 wordsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Atrial Fibrillation (AF) and Heart Failure (HF) are colliding global cardiovascular epidemics, individually impairing quality of life and cardiac performance, as well as increasing the risk of hospitalisation and mortality. When AF and HF co-exist, disease progression accelerates and the adverse outcomes are magnified, leading to incrementally higher morbidity, mortality, and healthcare expenditure. The management of AF is dichotomised into the restoration and maintenance of sinus rhythm ("Rhythm control") or acceptance of AF with control of the ventricular response ("Rate control"). Previous studies suggested that pharmacologic rhythm control and pharmacologic rate control confer similar survival and morbidity outcomes in patients with significant left ventricular dysfunction. Recognising the limitations of pharmacotherapy, more recent studies have examined the utility of catheter ablation procedures designed to restore and maintain sinus rhythm (e.g., catheter-based pulmonary vein isolation). Studies have suggested that catheter ablation procedures may provide sustained improvements in quality of life, decreased hospitalisation and, potentially, improved survival for patients with co-existing AF and HF, when compared to pharmacotherapy. However, significant limitations in these small trials have limited their impact on clinical practice. We propose a randomised controlled trial to definitively answer the question regarding the optimal treatment of AF in patients with heart failure with reduced ejection fraction (HFrEF), specifically aiming to determine if catheter ablation can reduce death, stroke, and heart failure events.
Trial Details
NCT Number NCT07238452
Lead Sponsor University of British Columbia
Conditions
(from sponsor)
Heart Failure With Reduced Ejection Fraction, Atrial Fibrillation (AF)
Related terms Atrial Fibrillation, Cardiomyopathies, Heart Failure
Enrollment 1,050 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov