Status:
RECRUITING
LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
End-stage Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- All patients ≥18 years,
- 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,
- Having a health coverage,
- Signed written informed consent,
- Patient without any legal protection measure.
Exclusion
- Inotrope dependent patients or existence of ongoing mechanical circulatory support (MCS) in the last 30 days,
- Right ventricular dysfunction (heart team consensus) with the expected need of Bi-VAD support,
- Female patients currently pregnant or women of childbearing age who were not using contraception,
- Active infection,
- Irreversible end-organ dysfunction prior to LVAD implantation,
- Contraindication to anti-coagulant or anti-platelet therapies,
- History of any organ transplant prior to inclusion,
- Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues likely to impair compliance,
- Frailty according to heart team,
- Platelet count \< 100,000 x 103/liter (\<100,000/ml)
- Body Surface Area (BSA) \< 1.2 m2,
- Any condition other than heart failure that could limit survival to less than 24 months,
- Chronic renal insufficiency (GFR definitely \<30 ml/min) or hepatic cirrhosis,
- Participation in any other interventional clinical investigation.
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04768322
Start Date
February 24 2021
End Date
February 1 2029
Last Update
December 24 2024
Active Locations (8)
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1
CHU Besançon
Besançon, France
2
Hôpital Pneumologique et Cardiovasculaire Louis Pradel
Bron, France
3
CHU Caen
Caen, France
4
La Tronche Hospital / CHU Grenoble
La Tronche, France