Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices

NCT ID: NCT02658136

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-08-15

Brief Summary

Exercise capacity in continous-flow left ventricular assist device (CF-LVAD) patients remains severely reduced post-implant. While the effect of right ventricular (RV) failure early after pump implantation, and its effect on outcome has been extensively studied, the effects of late RV failure on exercise capacity and quality of life (QOL) has been sparsely described. Thus the purpose of this study is to examine RV function and the association to exercise capacity in CF-LVAD patients.

Detailed Description

When pharmacological therapy becomes insufficient in advanced end-stage heart failure (HF) transplantation remains the gold standard of therapies. However, due to a severe lack of donor organs, mechanical circulatory support is an alternative option for some eligible patients. Mechanical circulatory support in the form of a CF-LVAD is a pump supporting the left ventricle by pumping blood from the apex to the ascending aortae. Implantation with a CF-LVAD increases survival and improves quality of life, but peak oxygen uptake (peak VO2) remains severely reduced post-implant. Complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance. Furthermore a fixed CF-LVAD pump speed prevents adequate circulatory support during strenuous exercise. The effects of late right ventricular (RV) failure on exercise capacity and quality of life (QOL) is, however, unknown and the purpose of this study is to examine RV function and the association to exercise capacity in CF-LVAD patients.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1 arm study: CCT estimated right ventricular function.

By use of Cardiac computed tomography, the ejection faction of the right ventricle will be visualized and measured in all participants.

Group Type: OTHER

Cardiac Computed tomography

Intervention Type: OTHER

Interventions

Cardiac Computed tomography

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Outpatients from Department of Cardiology, Rigshospitalet, Denmark.
• Age ≥ 18 years.
• Ischemic or non-ischemic cardiomyopathy.
• Signed informed consent.

Exclusion Criteria

• Unstable patients with the need for intravenous inotropic therapy.
• CF-LVAD implantation less than one month ago.
• eGFR < 45 ml/min.
• Contrast allergy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Finn Gustafsson

OTHER

Sponsor Role: lead

Responsible Party

Finn Gustafsson

MD; PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University Hospital Rigshospitalet.

Copenhagen, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

51347

Identifier Type: -

Identifier Source: org_study_id