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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)

NCT06667128 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-11-04

No results posted yet for this study

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)

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.

Sponsors & Collaborators

Principal Investigators

  • Francesco Maisano, Head of Cardiac Surgery · IRCCS Ospedale San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-02-01
Completion
2026-02-01

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06667128 on ClinicalTrials.gov