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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02592499
Other study ID # ver 6.0
Secondary ID 635-14
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date December 2025

Study information

Verified date April 2023
Source Vastra Gotaland Region
Contact Göran Dellgren, MD
Phone +4631-342 88 63
Email goran.dellgren@vgregion.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The primary objective is to compare survival between left Ventricular Assist Device (LVAD) destination therapy and optimal medical management in a Swedish end stage heart failure population ineligible for cardiac transplantation. The secondary objective is to compare treatment groups with respect to organ function, functional capacity, quality of life and adverse events. All patients enrolled in the study will be followed through 2 years. Patients who continue to be on going with the HM III or on OMM past 2 years will continue be followed for their outcomes and adverse events for up to 5 years. Patient recruitment was expected to occur over 24 months, but due to difficulties in recruiting patients will be longer (approximately 48 months) The study will be conducted in Sweden at all 7 University Hospitals and implantations will be performed in 5 sites.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2025
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
HM III

Other:
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.

Locations

Country Name City State
Sweden 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

Sponsors (7)

Lead Sponsor Collaborator
Vastra Gotaland Region Karolinska University Hospital, Region Örebro County, Skane University Hospital, University Hospital, Linkoeping, University Hospital, Umeå, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival at two years of follow-up survival 2 years,
Secondary Number of participants free from disabling stroke during the 2-year follow-up period Survival free from disabling stroke (Modified Rankin Scale (MRS) >3) 2 years
Secondary A composite endpoint of "survival free from disabling stroke", survival and non-planned hospitalizations Survival free from a composite endpoint of disabling stroke, survival and non-planned hospitalizations 2 years
Secondary Survival at year of follow-up Survival at year 1 year
Secondary Functional capacity (NYHA) during the 2-year follow-up period functional capacity determined by NYHA classification 2 years
Secondary Functional capacity (6 min walk-test) during the 2-year follow-up period functional capacity determined by 6 min walk-test 2 years
Secondary Functional capacity (peak VO2) functional capacity determined by peak VO2 2 years
Secondary Health-related quality of Life during the 2-year follow-up period Health-related quality of Life asses with EQ-5D-5L, SF-36 and KCCQ 2 years
Secondary Number of participants with heart-failure related events 2 years
Secondary Cost-effectiveness during the 2-year follow-up period Cost effectiveness calculated with QUALY (Quality-adjusted Life-year) and LY (Life year) 2 years
Secondary Renal function during the 2-year follow-up period Glomerular filtration rate evaluated by 51 chrome-EDTA or Iohexol clearance 2 years
Secondary Hospital admissions during the 2-year follow-up period Number of hospital admissions 2 years
Secondary Number of participants with serious adverse events (SAEs) 2 years
Secondary Functional capacity (peak VO2) functional capacity determined by peak VO2 1 year
Secondary Three-years survival survival 3 years
Secondary Four-years survival survival 4 years
Secondary Five-years survival survival 5 years
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