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

Chronic Heart Failure Clinical Trial

— HOMEX-HF-P  

Official title:

Cardiovascular Effects of Preferred Home-based Exercise Training and Extended Adherence Measures in Systolic Heart Failure - Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02051712
• Other study ID #: DZHK-HGW-001
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Heart Failure, Systolic

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