CClinicalTrials.gg
RecruitingNCT02051712HOMEX-HF-PUpdated Dec 12, 2023

Cardiovascular Effects of Preferred Home-based Exercise Training in Systolic Heart Failure

A Phase 3 interventional study of exercise training and Adherence measures in Chronic Heart Failure, sponsored by University Medicine Greifswald. Recruiting at 1 site in Germany. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by University Medicine Greifswald · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study summary

The aim of the study is I. To assess whether an individualized exercise training program is superior as compared to usual care with respect to exercise tolerance, II. to assess whether intervention tools that aim to increase exercise adherence are superior to an individualized exercise training alone with respect to exercise tolerance and long-term effects, and III. to identify biomarkers that that may be implemented into novel intervention tools aiming to increase exercise adherence in patients with chronic heart failure.

02

Conditions studied

  • Chronic Heart Failure

Keywords

  • chronic heart failure
  • exercise training
  • preferred training
  • prevention
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 120 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University Medicine Greifswald is the lead sponsor of 149 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • women and men
  • age 30-75 years
  • chronic heart failure (NYHA II/III), left ventricular ejection fraction ≤40% be echo
  • disease duration ≥ 6 month
  • medical therapy accruing to guidelines (drug, devices, including CRT)
  • written informed consent

Exclusion criteria

Exclusion Criteria:

  • acute myocarditis
  • instable angina
  • heart surgery (e.g. ICD implantation, bypass) with last 6 weeks; CRT implantation within the last 6 months before study start
  • severe cardiovascular events (myocardial infarction, cardiac decompensation, ICD shock, PCI due to instable angina) \< 6 weeks before study start
  • preplanned hospital admission or intervention (e.g. planned revascularization, ICD implantation)
  • uncorrected valve regurgitation or stenosis (> second degree)
  • safety concerns regarding or other reasons against exercise training
  • severe depression
  • regular exercise training within the last 6 weeks
  • life expectancy \< 1 year
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • No intervention
    Usual care

    Usual car accruing to guidelines

  • Experimental
    Individualized training

    Individualized exercise training program in addition to usual care

    Behavioral: exercise training

  • Experimental
    Individualized training plus adherence measures

    Individualized exercise training plus measures to increase adherence

    Behavioral: exercise training · Behavioral: Adherence measures

Interventions

  • Behavioralexercise training

    individualized exercise training

  • BehavioralAdherence measures

    Measures to increase adherence to exercise training

06

What researchers measure

Primary outcomes

  1. VO2@AT

    Change of cardiopulmonary exercise tolerance from baseline to 9 month follow-up measured by exercise testing: oxygen uptake at anaerobic threshold per kg body weight (METs)

    Time frame: Month 9

Secondary outcomes

  1. Training adherence

    Adherence to training sessions

    Time frame: 9, 12, 18 and 24 month

Other outcomes

  1. AE

    Adverse events, related and unrelated to exercise training

    Time frame: 9, 12, 18 and 24 month

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02051712
Lead sponsor
University Medicine Greifswald
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Responsible party
Sponsor
First posted
Jan 31, 2014
Start date
Feb 2014
Primary completion
Jul 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Dec 12, 2023

Study contacts

Marcus Dörr, MD
Contact
mdoerr@uni-greifswald.de
+49 3834 8680500
Stepahn B Felix, MD
Contact
felix@uni-greifswald.de
+4938348680500
Marcus Dörr, MD
principal investigator · University Greifswald

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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