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Clinical Trials in Sweden / NCT02592499
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Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure

NCT02592499 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2016-06
Last updated
2026-07-06

Condition(s) studied

End-stage Heart Failure

Investigational drug(s) / intervention(s)

HM IIIOMM, optimal medical management

OMM, optimal medical management: Patients randomized to OMM will be treated according to international guidelines. All patients should receive a beta blocker, an ACE-inhibitor or an Angiotension II receptor blocker, and a mineralocorticoid receptor antagonist if tolerated and at optimally titrated doses according to guidelines. Loop diuretics should also be used as needed to control fluid retention. Other drugs that may relieve symptoms and improve prognosis can be used (incl ivabradin, digoxin, hydralazine,isosorbiddinitrate, anticoagulant agents). Patients that have an indication for implantable cardioverter defibrillator (ICD) and/or cardiac resynchronization therapy (CRT) should receive such therapy. Surgical interventions that may be indicated for specific underlying or contributing causes of heart failure.

Study summary

The study is a prospective, randomized, non-blinded, national, multi-center study. The study will consist of the assignment of eligible patients to treatment with either a HeartMate III (HM III) left ventricular assist device system or to pharmacological treatment (optimal medical management, OMM) according to current guidelines. Eighty (80) patients will be enrolled in this study and randomized in a 1:1 fashion between the HM III and OMM, based on a modified power calculation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent 2. Adult (≥ 18 years) 3. Chronic heart failure ≥ 45 days or stable not supported by mechanical circulatory support since \>7days on single inotrope. 4. Left ventricular ejection fraction ≤ 30%. 5. NYHA IIIB-IV, INTERMACS profile 2-6 6. At least 2 of 4 adverse prognostic criteria: * SHFM estimated 1-year survival ≤75% * NTproBNP ≥ 2000 ng/l * VO2 max \< 14 ml/kg/min or \<50% of predicted VO2max with attainment of anaerobic threshold (AT), or unable to perform. * Need for continuous or intermittent inotropic support or \>2 hospitalizations during last 6 months. 7. Receiving medical management with optimal doses of betablockers, ACE-inhibitors or ARBs, and MRAs for at least 30 days if tolerated. 8. Receiving CRT if indicated for at least 45 days. 9. Receiving ICD if indicated and appropriate. 10. Ineligible for cardiac transplantation (e.g. high age and/or co-morbidities) 11. Considered suitable for the study by a multidisciplinary board Exclusion Criteria: 1. Eligible for heart transplantation or is likely to become eligible after VAD treatment (bridge-to-candidacy) 2. Indication for revascularisation, valvular surgery or other cardiac intervention expected to improve cardiac function and prognosis (CABG, PCI TAVI, mitraclip etc.) 3. INTERMACS profile 1 "crash and burn" 4. On-going mechanical circulatory support. 5. Heart failure due to restrictive cardiomyopathy pericardial disease, active myocarditis or uncorrected thyroid disease. 6. Mechanical aortic valve that will not be converted to a bioprosthesis or patch 7. Moderate to severe aortic insufficiency without plans for correction 8. Technical obstacles, which pose an inordinately high surgical risk 9. Active, uncontrolled infection 11\. Stroke within 90 days or carotid artery stenosis \> 80 % 12. Significant vascular disease. 13. Severe COPD or severe restrictive lung disease. 14. Intrinsic hepatic disease as defined by liver enzyme values (AST or ALT or total bilirubin) \> 5 times the upper limit of normal, or INR \> 2.0, which is not due to anti-coagulant therapy. 15\. Intolerance to anticoagulant or antiplatelet therapies or any other operative therapy the patient will require based upon the patient's health status. 16\. Platelet count \< 50,000. 17. Measured GFR \<20 ml/min/1.73m2 unresponsive to inotrope treatment or chronic dialysis. 18\. High risk for right ventricular failure according to echocardiography and/or invasive hemodynamic measurements as judged by the investigator (\>2 parameter constitute an exclusion criteria) using a combination of the: a. Severe TI b. TAPSE \< 0.72 cm c. RVEDD/LVEDD \> 0.72 d. CVP \> 16 mm Hg e. MPAP - RAP \< 10 mmHg SPAP-DPAP/CVPm \>1 ok, \<0.5 very bad, in between borderline f. CVP/PCWP \> 0.63 g. RVSWI \< 300 mm Hg x ml/m2 h. Bilirubin \> 34 micromol/L 19. Body Mass Index (BMI) \> 42 kg/m2. 20. Psychiatric disease, cognitive dysfunction, alcohol or drug abuse, or psychosocial issues that are likely to impair study compliance 21. Female of childbearing age with a positive pregnancy test or not willing to use adequate contraceptive precautions during the study. 22\. Condition, other than heart failure, that could limit survival to less than 2 years.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Sahlgrenska Univesitetssjukhustet, Transplantationscentrum Gothenburg Sweden
Linköping Univ Hospital Linköping Sweden
Skåne University Hospital Lund Sweden
Örebro Univ Hospital Örebro Sweden
Karolinska Univ Hospital Stockholm Sweden
Univ Hospital of Umeå Umeå Sweden
Uppsala Univ Hospital Uppsala Sweden

More Vastra Gotaland Region trials in Sweden

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02592499 on ClinicalTrials.gov ↗ ← All trials in Sweden