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RECRUITING
NCT04768322
NA

LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

Heart failure is a severe disease affecting approximately 1-2% of the adult population in developed countries and around 26 million people worldwide. Up to 10% of these patients are in advanced stage heart failure, which is defined by a significant morbimortality and considerable medical expenses. Despite advances in its medical management, advanced (or end stage) heart failure is characterized by refractoriness to conventional therapies including guideline-directed pharmacological and non-surgical device treatments. These patients remain severely symptomatic (NYHA IV) and have objective signs of congestion or low cardiac output. Left ventricular assist devices (LVADs) have been used in patients with heart failure with reduced ejection fraction for almost 20 years either as an alternative or a bridge to heart transplantation. LVADs improve heart failure symptoms and survival at the cost of increased rates of infection, stroke and bleeding. Despite the lack of evidence, LVAD implantation in ambulatory patients is not rare, with INTERMACS profiles ≥4 patients representing 15.7% of the overall population implanted between 2012 and 2016. The aim of this study is to investigate the efficacy and safety of left ventricular assist devices compared to traditional HF medical treatment alone in a population of ambulatory advanced heart failure patients. Secondary objectives are to better identify subgroups of patients that would benefit the most from the implantation of an LVAD as well as to assess the optimal timing of intervention.

Official title: Left Ventricular Assist Device (LVAD) Versus Guideline Recommended Medical Therapy in Ambulatory Advanced Heart Failure Patients (GDMT)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2021-02-24

Completion Date

2029-02

Last Updated

2024-12-24

Healthy Volunteers

No

Interventions

DEVICE

HeartMate 3 TM Left Ventricular Assist System

The HeartMate 3 TM Left Ventricular Assist System will be implanted within 21 days of randomization.

OTHER

Guideline Directed Medical Therapy

Patients randomized in the control group will continue their guideline directed medical therapy which comprises the following stable combination at the maximal tolerated dose of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or Angiotensin receptor Neprilysin inhibitor and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors if tolerated.

Locations (8)

CHU Besançon

Besançon, France

Hôpital Pneumologique et Cardiovasculaire Louis Pradel

Bron, France

CHU Caen

Caen, France

La Tronche Hospital / CHU Grenoble

La Tronche, France

Arnaud de Villeneuve Hospital / CHU Montpellier

Montpellier, France

CHU Rouen

Rouen, France

CHU Tours

Tours, France

CHRU, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu

Vandœuvre-lès-Nancy, France