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NCT number NCT03184311
Study type Interventional
Source Cantonal Hosptal, Baselland
Contact Thomas Dieterle, MD
Phone +41 61 925 32 30
Status Not yet recruiting
Phase N/A
Start date October 1, 2017
Completion date March 31, 2020

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 continuing to undergo usual care.

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. Furthermore, iron deficiency (ID) has been recognized to be a common comorbidity in HFpEF. The lack of prognostic treatment options in HFpEF urgently calls for new therapeutic approaches. While beneficial effects of exercise training and iron substitution 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 with optimally adjusted iron values.

The proposed study will be a prospective, single-blind, randomized controlled trial in a primary care setting including 98 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 and pulse wave velocity), exercise tolerance (using spiroergometry), habitual physical activity (using accelerometry) and QoL. After the screening visit, patients with a functional or absolute ID will undergo iron substitution until sufficient iron levels are reached (up to max. 12 weeks), in order to ensure comparable baseline conditions for the training intervention. The study examinations will be repeated after 12 weeks in both, initially iron deficient and non-iron deficient patients (baseline visit). Patients will then be randomized to either the intervention or control group, stratified by initial iron-deficiency status. The intervention group (n=49) will attend a supervised 12-week HIT on a bicycle ergometer, while the control group (n=49) will be advised to continue usual care and follow health recommendations for patients with chronic HF. 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.

Study Design

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