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Completed

NCT Number: NCT02658136

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Rigshospitalet.

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cardiac computed tomography

Other

Primary outcomes

  1. Peak Oxygen Uptake

    Time frame: Day 1

    Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Finn Gustafsson

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2016
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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