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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658136
• Other study ID #: 51347
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: August 15, 2017

Study information

• Verified date: March 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 15, 2017
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Cardiac Computed tomography

Locations

Country	Name	City	State
Denmark	University Hospital Rigshospitalet.	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Finn Gustafsson

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Oxygen Uptake	Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min.	Day 1
Secondary	Right Ventricular Function (RVEF) During Exercise	Right ventricular function during exercise was estimated by use of contrast enhanced cardiac computed tomography.	Day 1