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Compares treatment options for End-stage Heart Failure
Official title LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients
ClinicalTrials.gov ID: NCT04768322
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- NYHA III-IV (INTERMACS profile 4-6) and and
You likely can't join if
- 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,
See the full eligibility criteria
- 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)...
- 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...
- 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.
- 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 treatment clinical investigation.
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Bron, France
- Caen, France
- La Tronche, France
- Montpellier, France
- Rouen, France
- Tours, France
- Vandœuvre-lès-Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Bron, France; Caen, France; La Tronche, France; Montpellier, France; Rouen, France and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.