Clinical Trial

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

Not Yet Recruiting

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.

Summary

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.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2024-10-29.

Trial Details

NCT Number	NCT06667128
Lead Sponsor	IRCCS Ospedale San Raffaele Collaborators: Hoffmann-La Roche
Conditions	Heart Failure, Valvulopathy, Aortic Stenosis, Aortic Regurgitation Disease, Mitral Regurgitation, Tricuspid Regurgitation, Brain Natriuretic Peptide, Mitraclip +1 more
Enrollment	160 participants
Start Date	2025-02-01
Primary Completion	2026-02-01 (estimated)
Study Completion	2026-02-01 (estimated)
Updated on ClinicalTrials.gov	2024-11-04