Comparing LVAD and medical therapy for advanced heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Guillaume BAUDRY, Dr — CHRU Nancy
• Study coordinator: Guillaume BAUDRY, Dr
• Email: g.baudry@chru-nancy.fr
• Phone: 383157331

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Impact of Impella 5.5 on heart function in adults with end-stage heart failure

  This study tests whether the Impella 5.5 helps the heart’s two sides work better in adults with severe heart failure who need temporary support.

  Recruiting University of Rochester · Rochester, New York · NCT07534462

• Long-term outcomes after LVAD implantation for end-stage heart failure

  We will follow adults with end-stage heart failure who get an LVAD to see if they live longer and to record complications and hospital visits over the next 3–5 years.

  Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07382284

• Noninvasive monitoring of heart function in patients with LVADs

  This study is testing new ways to monitor heart function in people with a HeartMate 3 LVAD to see if they can get better information than the usual methods like echocardiograms and ECGs.

  Recruiting Medical University of Vienna · Vienna · NCT04641416

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.