Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure
NCT ID: NCT02592499
Last Updated: 2023-04-26
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
80 participants
INTERVENTIONAL
2016-06-30
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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HM III
Patients randomized to mechanical circulatory support will be treated with the HeartMate III (HM III) left ventricular assist device system.
HM III
OMM, Optimal Medical Management
Patients randomized to OMM will be treated according to international guidelines.
ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Eur Heart J. 2012 Jul;33(14):1787-84
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.
Interventions
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HM III
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
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.
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
University Hospital, Linkoeping
OTHER
Skane University Hospital
OTHER
Uppsala University Hospital
OTHER
University Hospital, Umeå
OTHER
Region Örebro County
OTHER
Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Kristjan Karason, MD
Role: PRINCIPAL_INVESTIGATOR
Vastra Gotaland Region
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Peter Wodlin, MD
Role: primary
Oscar Braun, MD
Role: primary
Barna Szado, MD
Role: primary
Lars Lund, MD
Role: primary
Krister Lindmark, MD
Role: primary
Ola Vedin, MD
Role: primary
Other Identifiers
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635-14
Identifier Type: OTHER
Identifier Source: secondary_id
ver 6.0
Identifier Type: -
Identifier Source: org_study_id
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