NCT02658136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2017

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

June 14, 2022

Completed
Last Updated

June 14, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

January 12, 2016

Results QC Date

March 9, 2021

Last Update Submit

March 12, 2022

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Peak Oxygen Uptake

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

    Day 1

Secondary Outcomes (1)

  • Right Ventricular Function (RVEF) During Exercise

    Day 1

Study Arms (1)

1 arm study: CCT estimated right ventricular function.

OTHER

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

Interventions

Cardiac Computed tomographyOTHER
1 arm study: CCT estimated right ventricular function.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients from Department of Cardiology, Rigshospitalet, Denmark.
  • Age ≥ 18 years.
  • Ischemic or non-ischemic cardiomyopathy.
  • Signed informed consent.

You may not qualify if:

  • Unstable patients with the need for intravenous inotropic therapy.
  • CF-LVAD implantation less than one month ago.
  • eGFR \< 45 ml/min.
  • Contrast allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Rigshospitalet.

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr Kiran Mirza
Organization
Rigshospitalet
KMIR0003@regionh.dk
004535451442

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD; PhD

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 18, 2016

Study Start

February 1, 2016

Primary Completion

August 15, 2017

Study Completion

August 15, 2017

Last Updated

June 14, 2022

Results First Posted

June 14, 2022

Record last verified: 2022-03

Locations

DK(1)