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Optimization of Heart Failure (HF) Medical Therapy After Transcatheter Valve Intervention (TVI) in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)

Study acronym: OPTIMAV
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated November 4, 2024 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Secondary endpoints revised (6)
    • Site details revised
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This trial is a single-center, open-label, randomized study designed to assess the impact of a rapid up-titration of Guideline-Directed Medical Therapy (GDMT) on heart failure with reduced ejection fraction (HFrEF) patients following transcatheter valve interventions. The study focuses on the efficacy of intensive treatment in decreasing NT-proBNP levels and improving patient outcomes, including survival rates and quality of life over a six-month period. Patients are closely monitored using both Point-of-Care technology and hospital-based assessments, with the goal of enhancing GDMT adjustments. This approach is compared to standard care to determine its potential benefits in the management of HFrEF post-valve intervention.
Trial Details
NCT Number NCT06667128
Lead Sponsor IRCCS Ospedale San Raffaele
Collaborators: Hoffmann-La Roche
Conditions
(from sponsor)		 Heart Failure, Valvulopathy, Aortic Stenosis, Aortic Regurgitation Disease, Mitral Regurgitation, Tricuspid Regurgitation, Brain Natriuretic Peptide, Mitraclip +1 more
Related terms Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure, Heart Valve Diseases, Mitral Valve Insufficiency, Tricuspid Valve Insufficiency
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov