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

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2025

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.

Trial Locations (7)

41234

RECRUITING

Sahlgrenska Univesitetssjukhustet, Transplantationscentrum, Gothenburg

Unknown

RECRUITING

Linköping Univ Hospital, Linköping

RECRUITING

Skåne University Hospital, Lund

RECRUITING

Örebro Univ Hospital, Örebro

RECRUITING

Karolinska Univ Hospital, Stockholm

RECRUITING

Univ Hospital of Umeå, Umeå

RECRUITING

Uppsala Univ Hospital, Uppsala

All Listed Sponsors
collaborator

Karolinska University Hospital

OTHER

collaborator

University Hospital, Linkoeping

OTHER

collaborator

Skane University Hospital

OTHER

collaborator

Uppsala University Hospital

OTHER

collaborator

University Hospital, Umeå

OTHER

collaborator

Region Örebro County

OTHER

lead

Vastra Gotaland Region

OTHER_GOV

NCT02592499 - Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure | Biotech Hunter | Biotech Hunter