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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)
Sponsor: IRCCS Ospedale San Raffaele
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.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-02-01
Completion Date
2026-02-01
Last Updated
2024-11-04
Healthy Volunteers
No
Conditions
Interventions
Rapid Uptitration of Guideline-Directed Medical Therapy
Rapid up-titration of GDMT guided by protocol-specific guideline.
Elecsys® NT-proBNP - Roche Diagnostics
An assay provided by Roche (Elecsys® NT-proBNP - Roche Diagnostics) will be used to assess NT-proBNP levels in the Rapid Up-Titration GDMT Group with Point-of-Care (PoC) Monitoring, with the purpose of evaluating any differences in marker dosage between the indicated method and the monitoring by the hospital laboratory analysis.
Rapid Up-Titration GDMT Group with Hospital Monitoring
Rapid Up-Titration GDMT Group guided by protocol-specific guideline and hospital monitoring.
Locations (1)
IRCCS Ospedale San Raffaele
Milan, Italy