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

March 12, 2022 updated by: Finn Gustafsson

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • University Hospital Rigshospitalet.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: Cardiac Computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Oxygen Uptake
Time Frame: Day 1
Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right Ventricular Function (RVEF) During Exercise
Time Frame: Day 1
Right ventricular function during exercise was estimated by use of contrast enhanced cardiac computed tomography.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finn Gustafsson

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

August 15, 2017

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 15, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

March 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51347

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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