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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Cardiac Computed tomography

• Registration Number: NCT02658136
• Lead Sponsor: Finn Gustafsson

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.

Study Timeline

• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-15
• Study First Posted: 2016-01-18
• Study Start: 2016-02
• Primary Completion: 2017-08-15
• Study Completion: 2017-08-15
• Results First Submitted: 2021-03-09
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-12
• Last Update Submitted: 2022-03-12
• Results First Posted: 2022-06-14
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 arm study: CCT estimated right ventricular function.	Cardiac Computed tomography	By use of Cardiac computed tomography, the ejection faction of the right ventricle will be visualized and measured in all participants.

Primary Outcome Measures

Name	Time	Method
Peak Oxygen Uptake	Day 1	Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min.

Secondary Outcome Measures

Name	Time	Method
Right Ventricular Function (RVEF) During Exercise	Day 1	Right ventricular function during exercise was estimated by use of contrast enhanced cardiac computed tomography.

Trial Locations

Locations (1)

University Hospital Rigshospitalet.; 🇩🇰 Copenhagen, Denmark