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Cardiovascular Effects of Preferred Home-based Exercise Training in Systolic Heart Failure (HOMEX-HF-P)

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ClinicalTrials.gov Identifier: NCT02051712
Recruitment Status : Recruiting
First Posted : January 31, 2014
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
University Medicine Greifswald

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Behavioral: exercise training Behavioral: Adherence measures Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cardiovascular Effects of Preferred Home-based Exercise Training and Extended Adherence Measures in Systolic Heart Failure - Pilot Study
Study Start Date : February 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual care
Usual car accruing to guidelines
Experimental: Individualized training
Individualized exercise training program in addition to usual care
Behavioral: exercise training
individualized exercise training

Experimental: Individualized training plus adherence measures
Individualized exercise training plus measures to increase adherence
Behavioral: exercise training
individualized exercise training

Behavioral: Adherence measures
Measures to increase adherence to exercise training




Primary Outcome Measures :
  1. VO2@AT [ Time Frame: Month 9 ]
    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)


Secondary Outcome Measures :
  1. Training adherence [ Time Frame: 9, 12, 18 and 24 month ]
    Adherence to training sessions


Other Outcome Measures:
  1. AE [ Time Frame: 9, 12, 18 and 24 month ]
    Adverse events, related and unrelated to exercise training



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

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): NCT02051712


Contacts
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Contact: Marcus Dörr, MD +49 3834 8680500 mdoerr@uni-greifswald.de
Contact: Stepahn B Felix, MD +4938348680500 felix@uni-greifswald.de

Locations
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Germany
Marcus Dörr Recruiting
Greifswald, Germany, 17475
Contact: Marcus Dörr, MD    +49 3834 8680500    mdoerr@uni-greifswald.de   
Contact: Stephan B Felix, MD    +4938348680500    felix@uni-greifswald.de   
Sponsors and Collaborators
University Medicine Greifswald
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
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Principal Investigator: Marcus Dörr, MD University Greifswald

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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT02051712     History of Changes
Other Study ID Numbers: DZHK-HGW-001
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

Keywords provided by University Medicine Greifswald:
chronic heart failure
exercise training
preferred training
prevention

Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases