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NOT YET RECRUITING
NCT06667128
NA

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

View on ClinicalTrials.gov

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

Interventions

OTHER

Rapid Uptitration of Guideline-Directed Medical Therapy

Rapid up-titration of GDMT guided by protocol-specific guideline.

DIAGNOSTIC_TEST

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.

OTHER

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