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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658136
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Finn Gustafsson, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Cardiac Computed tomography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Computed Tomography Estimated Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices
Study Start Date : February 2016
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : August 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
1 arm study: CCT estimated right ventricular function. Other: Cardiac Computed tomography



Primary Outcome Measures :
  1. RV function during rest and exercise estimated by CCT. [ Time Frame: Day 1 ]
    Right ventricular function during rest and exercise estimated by CCT.


Secondary Outcome Measures :
  1. Peak oxygen uptake in ml/kg/min. [ Time Frame: Day 1 ]
    Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658136


Locations
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Denmark
University Hospital Rigshospitalet.
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Finn Gustafsson
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Responsible Party: Finn Gustafsson, MD; PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02658136    
Other Study ID Numbers: 51347
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases