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

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

Interventions

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.

Sponsors & Collaborators

• Karolinska University Hospital

  collaborator OTHER

• University Hospital, Linkoeping

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• University Hospital, Umeå

  collaborator OTHER

• Region Örebro County

  collaborator OTHER

• Vastra Gotaland Region

  lead OTHER_GOV

Principal Investigators

• Kristjan Karason, MD · Vastra Gotaland Region

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2023-12-31

Completion

2025-12-31

Countries

• Sweden

Study Locations