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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02051712
Other study ID # DZHK-HGW-001
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 2014
Est. completion date December 2024

Study information

Verified date December 2023
Source University Medicine Greifswald
Contact Marcus Dörr, MD
Phone +49 3834 8680500
Email mdoerr@uni-greifswald.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 75 Years
Eligibility 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

Study Design


Intervention

Behavioral:
exercise training
individualized exercise training
Adherence measures
Measures to increase adherence to exercise training

Locations

Country Name City State
Germany Marcus Dörr Greifswald

Sponsors (2)

Lead Sponsor Collaborator
University Medicine Greifswald Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other AE Adverse events, related and unrelated to exercise training 9, 12, 18 and 24 month
Primary 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) Month 9
Secondary Training adherence Adherence to training sessions 9, 12, 18 and 24 month
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