Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure

NCT02592499 | Unknown DMC

• 2 other identifiers: ver 6.0635-14
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

End-stage Heart Failure

Keywords

HM III; survival; LVAD

Outcome Measures

Primary Outcomes (1)

• Survival at two years of follow-up

  survival

  2 years,

Secondary Outcomes (16)

• Number of participants free from disabling stroke during the 2-year follow-up period

  2 years

• A composite endpoint of "survival free from disabling stroke", survival and non-planned hospitalizations

  2 years

• Survival at year of follow-up

  1 year

• Functional capacity (NYHA) during the 2-year follow-up period

  2 years

• Functional capacity (6 min walk-test) during the 2-year follow-up period

  2 years

Study Arms (2)

HM III

EXPERIMENTAL

Patients randomized to mechanical circulatory support will be treated with the HeartMate III (HM III) left ventricular assist device system.

Device: HM III

OMM, Optimal Medical Management

ACTIVE COMPARATOR

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

Other: OMM, optimal medical management

Interventions

HM III DEVICE

Also known as: left ventrical assist device, LVAD

HM III

OMM, optimal medical management OTHER

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.

OMM, Optimal Medical Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Adult (≥ 18 years)
• Chronic heart failure ≥ 45 days or stable not supported by mechanical circulatory support since \>7days on single inotrope.
• Left ventricular ejection fraction ≤ 30%.
• NYHA IIIB-IV, INTERMACS profile 2-6
• 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.
• Receiving medical management with optimal doses of betablockers, ACE-inhibitors or ARBs, and MRAs for at least 30 days if tolerated.
• Receiving CRT if indicated for at least 45 days.
• Receiving ICD if indicated and appropriate.
• Ineligible for cardiac transplantation (e.g. high age and/or co-morbidities)
• Considered suitable for the study by a multidisciplinary board

You may not qualify if:

• Eligible for heart transplantation or is likely to become eligible after VAD treatment (bridge-to-candidacy)
• Indication for revascularisation, valvular surgery or other cardiac intervention expected to improve cardiac function and prognosis (CABG, PCI TAVI, mitraclip etc.)
• INTERMACS profile 1 "crash and burn"
• On-going mechanical circulatory support.
• Heart failure due to restrictive cardiomyopathy pericardial disease, active myocarditis or uncorrected thyroid disease.
• Mechanical aortic valve that will not be converted to a bioprosthesis or patch
• Moderate to severe aortic insufficiency without plans for correction
• Technical obstacles, which pose an inordinately high surgical risk
• Active, uncontrolled infection
• \. 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.
• \. Intolerance to anticoagulant or antiplatelet therapies or any other operative therapy the patient will require based upon the patient's health status.
• \. 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.
• \. Condition, other than heart failure, that could limit survival to less than 2 years.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Karolinska University Hospital: collaborator
• University Hospital, Linkoeping: collaborator
• Skane University Hospital: collaborator
• Uppsala University Hospital: collaborator
• University Hospital, Umeå: collaborator
• Region Örebro County: collaborator

Study Sites (7)

Sahlgrenska Univesitetssjukhustet, Transplantationscentrum

Gothenburg, 41234, Sweden

RECRUITING

Linköping Univ Hospital

Linköping, Sweden

RECRUITING

Skåne University Hospital

Lund, Sweden

RECRUITING

Örebro Univ Hospital

Örebro, Sweden

RECRUITING

Karolinska Univ Hospital

Stockholm, Sweden

RECRUITING

Univ Hospital of Umeå

Umeå, Sweden

RECRUITING

Uppsala Univ Hospital

Uppsala, Sweden

RECRUITING

Study Officials

• Kristjan Karason, MD

  Vastra Gotaland Region

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Göran Dellgren, MD

CONTACT

+4631-342 88 63; goran.dellgren@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 30, 2015
• Study Start: June 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication
• Access Criteria: Not decided yet

Locations

SE (7)