Optimization of Heart Failure (HF) Medical Therapy After Transcatheter Valve Intervention (TVI) in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)

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

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorIRCCS Ospedale San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hospital admission for severe symptomatic valve disease (aortic stenosis, mitral regurgitation, or tricuspid regurgitation) effectively treated with transcatheter valve intervention (TVI) during hospitalization.

Chronic heart failure with reduced ejection fraction (HFrEF)

NT-proBNP > 900 pg/mL.

Systolic blood pressure ≥ 100 mmHg.

Disqualifiers

Age < 18 or > 85 years.

Clearly documented intolerance to ACEi/ARB/ARNI, or beta-blockers, or MRA, or SGLT2i.

Residual severe valve disease of the valve treated with TVI (i.e. severe aortic stenosis or severe paravalvular leak after TAVR, severe mitral stenosis or severe residual mitral regurgitation after mitral valve intervention, or severe tricuspid stenosis or severe residual tricuspid regurgitation after tricuspid valve intervention).

Presence at the time of randomization (1-2 days prior to discharge) of any severe valve disease.

Trial design

Design model

Parallel

Treatments tested in this trial

Rapid Uptitration of Guideline-Directed Medical Therapy
Other intervention
Rapid up-titration of GDMT guided by protocol-specific guideline.
Elecsys® NT-proBNP - Roche Diagnostics
Diagnostic test
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
Other intervention
Rapid Up-Titration GDMT Group guided by protocol-specific guideline and hospital monitoring.

Treatment groups

160 Participants

are divided into 3 treatment groups

Group A: Standard Care GroupNo intervention 0 interventions

Group B: Rapid Up-Titration GDMT Group with Point-of-Care (PoC) MonitoringExperimental treatment 2 interventions

Group C: Rapid Up-Titration GDMT Group with Hospital MonitoringExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Composite Hierarchical Outcome for Mortality, Heart Failure Hospitalization, and NT-proBNP Response

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).

Time frame