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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
80
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.
Sahlgrenska Univesitetssjukhustet, Transplantationscentrum
Gothenburg, Sweden
RECRUITINGLinköping Univ Hospital
Linköping, Sweden
RECRUITINGSkåne University Hospital
Lund, Sweden
Survival at two years of follow-up
survival
Time frame: 2 years,
Number of participants free from disabling stroke during the 2-year follow-up period
Survival free from disabling stroke (Modified Rankin Scale (MRS) \>3)
Time frame: 2 years
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
Time frame: 2 years
Survival at year of follow-up
Survival at year
Time frame: 1 year
Functional capacity (NYHA) during the 2-year follow-up period
functional capacity determined by NYHA classification
Time frame: 2 years
Functional capacity (6 min walk-test) during the 2-year follow-up period
functional capacity determined by 6 min walk-test
Time frame: 2 years
Functional capacity (peak VO2)
functional capacity determined by peak VO2
Time frame: 2 years
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
Time frame: 2 years
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Örebro Univ Hospital
Örebro, Sweden
RECRUITINGKarolinska Univ Hospital
Stockholm, Sweden
RECRUITINGUniv Hospital of Umeå
Umeå, Sweden
RECRUITINGUppsala Univ Hospital
Uppsala, Sweden
RECRUITINGNumber of participants with heart-failure related events
Time frame: 2 years
Cost-effectiveness during the 2-year follow-up period
Cost effectiveness calculated with QUALY (Quality-adjusted Life-year) and LY (Life year)
Time frame: 2 years
Renal function during the 2-year follow-up period
Glomerular filtration rate evaluated by 51 chrome-EDTA or Iohexol clearance
Time frame: 2 years
Hospital admissions during the 2-year follow-up period
Number of hospital admissions
Time frame: 2 years
Number of participants with serious adverse events (SAEs)
Time frame: 2 years
Functional capacity (peak VO2)
functional capacity determined by peak VO2
Time frame: 1 year
Three-years survival
survival
Time frame: 3 years
Four-years survival
survival
Time frame: 4 years
Five-years survival
survival
Time frame: 5 years