Brief 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.

Conditions

• Heart Failure
• Valvulopathy
• Aortic Stenosis
• Aortic Regurgitation Disease
• Mitral Regurgitation
• Tricuspid Regurgitation
• Brain Natriuretic Peptide
• Mitraclip
• TAVI(Transcatheter Aortic Valve Implantation)

Intervention / Treatment

• Other: Rapid Uptitration of Guideline-Directed Medical Therapy
• Diagnostic Test: Elecsys® NT-proBNP - Roche Diagnostics
• Other: Rapid Up-Titration GDMT Group with Hospital Monitoring

Primary Outcome Measures

• Composite Hierarchical Outcome for Mortality, Heart Failure Hospitalization, and NT-proBNP Response (From enrollment to the end of treatment (up to 6 months).)
  Hierarchical composite endpoint composed of (1) all-cause death, (2) number of HF hospitalization, (3) improvement of NT-proBNP (with an improvement defined as a decrease of at least 30% from baseline).

Countries

Italy

Locations and Investigators

• IRCCS Ospedale San Raffaele, Milan, Italy
  • Cosmo Godino, Co-PI

Study Officials

• Francesco Maisano, Head of Cardiac Surgery (Principal Investigator) — IRCCS Ospedale San Raffaele