Comparing LVAD and medical therapy for advanced heart failure patients

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

This study tests whether the HeartMate 3 device can help people with severe heart failure feel better and live healthier lives compared to standard medical treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospices Civils de Lyon (other)
• Locations: 8 sites (Besançon and 7 other locations)
• Trial ID: NCT04768322 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the HeartMate 3 Left Ventricular Assist Device (LVAD) compared to guideline-directed medical therapy (GDMT) in patients with advanced heart failure. It targets individuals with severe symptoms and limited treatment options, assessing outcomes related to heart function and quality of life. Participants will be randomly assigned to receive either the LVAD or continue with optimized medical management. The study aims to provide insights into the benefits and risks associated with LVAD implantation in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with end-stage heart failure who have not responded adequately to optimal medical therapy.

Not a fit: Patients who are not in the advanced stages of heart failure or those who are inotrope-dependent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that significantly improves survival and quality of life for patients with end-stage heart failure.

How similar studies have performed: Previous studies have shown promising results with LVADs in heart failure management, indicating that this approach has potential based on existing evidence.

Eligibility criteria

Inclusion Criteria:

1. All patients ≥18 years,
2. End-stage heart failure, evaluated by the local Heart Team, defined as:

   * Left ventricular ejection fraction ≤ 35% within 1 week prior to randomization and
   * Cardiac Index \< 2.2 L/min/m² by hemodynamic use within 1 month prior to randomization or VO2 max \< 14 ml/kg/min (or \<50% of predicted VO2max) within 1 month prior to randomization OR low 6-min walking test (\< 420 m) within 1 month prior to randomization or ≥ 2 hospitalizations for heart failure in the past year and
   * NYHA III-IV (INTERMACS profile 4-6) and and
   * Receiving medical management with optimal doses of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible) and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors for at least 45 days if tolerated according to guideline at maximal tolerated dose (if maximal HF drug dosage is not reached the investigators will have to explain reason behind not maximal dosage).
   * Receiving Cardiac Resynchronization Therapy and or Implantable Cardioverter Defibrillators if indicated for at least 45 days and
   * No mechanical circulatory support or inotrope therapy since \> 30 days,
3. Having a health coverage,
4. Signed written informed consent,
5. Patient without any legal protection measure.

Exclusion Criteria:

1. Inotrope dependent patients or existence of ongoing mechanical circulatory support (MCS) in the last 30 days,
2. Right ventricular dysfunction (heart team consensus) with the expected need of Bi-VAD support,
3. Female patients currently pregnant or women of childbearing age who were not using contraception,
4. Active infection,
5. Irreversible end-organ dysfunction prior to LVAD implantation,
6. Contraindication to anti-coagulant or anti-platelet therapies,
7. History of any organ transplant prior to inclusion,
8. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues likely to impair compliance,
9. Frailty according to heart team,
10. Platelet count \< 100,000 x 103/liter (\<100,000/ml)
11. Body Surface Area (BSA) \< 1.2 m2,
12. Any condition other than heart failure that could limit survival to less than 24 months,
13. Chronic renal insufficiency (GFR definitely \<30 ml/min) or hepatic cirrhosis,
14. Participation in any other interventional clinical investigation.

Where this trial is running

Besançon and 7 other locations

• CHU Besançon — Besançon, France (RECRUITING)
• Hôpital Pneumologique et Cardiovasculaire Louis Pradel — Bron, France (RECRUITING)
• CHU Caen — Caen, France (RECRUITING)
• La Tronche Hospital / CHU Grenoble — La Tronche, France (RECRUITING)
• Arnaud de Villeneuve Hospital / CHU Montpellier — Montpellier, France (RECRUITING)
• CHU Rouen — Rouen, France (RECRUITING)
• CHU Tours — Tours, France (RECRUITING)
• CHRU, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu — Vandœuvre-lès-Nancy, France (RECRUITING)

Study contacts

• Principal investigator: Guillaume BAUDRY, Dr — CHRU Nancy
• Study coordinator: Guillaume BAUDRY, Dr

Conditions: End-stage Heart Failure, Heart Failure, End-stage, Not inotrope-dependent, Left Ventricular Assist Device, HeartMate 3 system, Heart Surgery, Guideline Directed Medical Therapy