NCT03369938

Brief Summary

The objective of the study is to test whether 12 weeks of structured supervised exercise training on top of usual care improves functional capacity in patients with end-stage heart failure with continuous flow left ventricular assist device (LVAD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

5 active sites

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

November 15, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

December 4, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

3.1 years

First QC Date

November 15, 2017

Last Update Submit

January 26, 2021

Conditions

Heart Failure

Keywords

left ventricular assist deviceexercise training

Outcome Measures

Primary Outcomes (1)

  • change in maximal exercise capacity

    cardiopulmonary exercise testing (CPET; peakVO2)

    after 12 weeks of treatment

Secondary Outcomes (14)

  • change in ventilatory efficacy

    after 12 weeks of treatment and 12 weeks of follow-up

  • change in submaximal exercise tolerance

    after 12 weeks of treatment and 12 weeks of follow-up

  • change in muscle strength

    after 12 weeks of treatment and 12 weeks of follow-up

  • change in body composition

    after 12 weeks of treatment and 12 weeks of follow-up

  • Kansas City Cardiomyopathy Questionnaire (KCCQ)

    after 12 weeks of treatment and 12 weeks of follow-up

  • +9 more secondary outcomes

Other Outcomes (1)

  • adherence to exercise training

    up to 12 weeks of treatment

Study Arms (2)

exercise training intervention

EXPERIMENTAL
Other: exercise training intervention

usual care

NO INTERVENTION

Interventions

exercise training interventionOTHER

structured aerobic endurance/resistance training on top of usual care for 12 weeks (3x/week)

exercise training intervention

Eligibility Criteria

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

You may qualify if:

  • chronic end-stage systolic heart failure
  • stable on left ventricular assist device, meaning
  • no major change in therapeutic regime within past 4 weeks: no new additional disease modifying drug (ACE inhibitor, ARB, sacubitril, beta-blocker), no change in disease modifying drug dosage more than 50% (excluded: diuretics), no initiation of a cardiac rehabilitation for a minimum of 4 weeks
  • post implantation ≥ 3 months
  • expected further period on the device for a minimum of 3 months after recruitment into the study
  • ability to complete the study in compliance with the protocol.
  • general ability of the patient to declare willingness to participate in the trial.
  • written informed consent

You may not qualify if:

  • acute illness that does not allow exercise, including unstable heart failure, acute myocarditis, acute pericarditis, stroke
  • untreated life-threatening cardiac arrhythmias
  • uncontrolled hypertension
  • intracardiac thrombus
  • inability to perform cardiopulmonary exercise testing at least 1 minute at 20W
  • uncontrolled diabetes
  • uncontrolled kidney disease
  • recent embolism
  • concurrent, continuous, or intermittent dobutamine therapy
  • complex ventricular arrhythmia at rest or appearing with exertion
  • supine resting heart rate \> 100 beats per minute
  • severe pulmonary instability
  • hemodynamically relevant valvular disorders
  • severe anemia (hemoglobin \<8 g/dl), however patients with moderate anemia (hemoglobin \<11 g/dl) may be recruited if clinically stable (investigator assessment)
  • clinically relevant musculoskeletal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Klinikum rechts der Isar der Technischen Universität München und Klinikum der Universität München

München, 80992, Germany

Location

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor for Cardiovascular Prevention and Clinical Heart Failure Research

Study Record Dates

First Submitted

November 15, 2017

First Posted

December 12, 2017

Study Start

December 4, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

DE(5)