LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients
NCT ID: NCT04768322
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
92 participants
INTERVENTIONAL
2021-02-24
2029-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early Left Ventricular Assist Device and Guideline Directed Medical Therapy
The intervention group will receive an early left ventricular assist device implantation (bridge to transplantation, bridge to candidacy or destination therapy) in addition to guideline directed medical therapy within 21 days of randomization.
HeartMate 3 TM Left Ventricular Assist System
The HeartMate 3 TM Left Ventricular Assist System will be implanted within 21 days of randomization.
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.
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.
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.
Interventions
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HeartMate 3 TM Left Ventricular Assist System
The HeartMate 3 TM Left Ventricular Assist System will be implanted within 21 days of randomization.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Guillaume BAUDRY, Dr
Role: PRINCIPAL_INVESTIGATOR
CHRU Nancy
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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MARIE FRANCE SERONDE, Pr
Role: primary
MATTEO POZZI, Dr
Role: primary
KATRIEN DR BLANCHART, Dr
Role: primary
AUDE BOIGNARD
Role: primary
Valentin DUPASQUIER
Role: primary
FABRICE BAUER
Role: primary
Thierry BOURGUIGNON, Dr
Role: primary
GUILLAUME BAUDRY
Role: primary
Other Identifiers
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ID-RCB
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL20_0072
Identifier Type: -
Identifier Source: org_study_id