High-intensity Interval Training in Heart Failure Patients With Preserved Ejection Fraction — HIT-HF  

Heart Failure With Normal Ejection Fraction Clinical Trial

Official title: High-intensity Interval Training as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction: A Prospective, Single-blind, Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

This study investigates the effects of a 12-week high-intensity interval training (HIT) on exercise tolerance, functional status and quality of life in patients with chronic heart failure with preserved ejection fraction (HFpEF), in comparison to a control group undergoing a 12-week moderate-intensity continuous training.

Clinical Trial Description

Heart failure (HF) with preserved ejection fraction (HFpEF) occurs in about 50% of all HF patients. Remodeling and fibrosis stimulated by inflammation appear to be main factors for the progression of HFpEF. The lack of prognostic treatment options in HFpEF urgently calls for new therapeutic approaches. While beneficial effects of exercise training have been demonstrated in HF with reduced ejection fraction, they have not yet been evaluated in HFpEF. Therefore, the aim of this study is to investigate the effects of high-intensity interval training (HIT) in HFpEF patients.

The proposed study will be a prospective, single-blind, randomized controlled trial in a primary care setting including 86 patients with stable HFpEF. Patients will undergo 3 study visits (a screening visit, a baseline visit and a post-intervention visit) including measurements of disease-specific biomarkers (using blood samples), cardiac and arterial vessel structure and function (using electrocardiogram, echocardiography, pulse wave velocity, flow-mediated dilation, retinal vessel analysis, cold pressure test), exercise tolerance (using spiroergometry), muscle function (using near-infrared spectroscopy, muscle strength tests), habitual physical activity (using accelerometry) and QoL. After the baseline visit, patients will be randomized to either the intervention or control group. The intervention group (n=43) will attend a supervised 12-week HIT on a bicycle ergometer, while the control group (n=43) will attend a supervised 12-week moderate-intensity continuous training (MCT). After 12 weeks, the study measurements will be repeated in all patients (intervention and control group) in order to monitor the effects of the intervention (post-intervention visit). At 6 months, 1, 2 and 3 years after the last study visit, telephone interviews will be performed to assess medical outcomes and QoL.

Outlook: This study is expected to add important knowledge about the potential utility of a novel treatment strategy in HFpEF patients, which may help to improve both, QoL and functional status. Moreover, the analysed biomarkers might be able to provide further insight into prognosis and pathogenesis of HFpEF. ;

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Normal Ejection Fraction

• NCT number: NCT03184311
• Study type: Interventional
• Source: University of Basel
• Contact: Arno Schmidt-Trucksäss, MD
• Phone: +41 61 2074741
• Email: arno.schmidt-trucksaess@unibas.ch
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Completion date: March 2023