Health Trials

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

ConditionsHeart FailureValvulopathyAortic StenosisAortic Regurgitation DiseaseMitral RegurgitationTricuspid RegurgitationBrain Natriuretic PeptideMitraclipTAVI(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

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

Treatments tested in this trial

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

Treatment groups

160 Participants
are divided into 3 treatment groups

Sponsors and collaborators

IRCCS Ospedale San Raffaele

Lead sponsor

Hoffmann-La Roche

Collaborator

Source ClinicalTrials.gov