Optimising exercise training in prevention and treatment of diastolic heart failure (OptimEx-CLIN): rationale and design of a prospective, randomised, controlled trial.

Abstract:

BACKGROUND:Heart failure with preserved left ventricular ejection fraction (HFpEF) currently affects more than seven million Europeans and is the only cardiovascular disease increasing in prevalence and incidence. No pharmacological agent has yet been shown to improve symptoms or prognosis. The most promising way to improve pathophysiology and deprived exercise-tolerance in HFpEF patients seems to be exercise training, but the optimal approach and dose of exercise is still unknown. OBJECTIVES:The major objective of the optimising exercise training in prevention and treatment of diastolic heart failure study (OptimEx-CLIN) is to define the optimal dose of exercise training in patients with HFpEF. In order to optimise adherence, supervision and economic aspects of exercise training a novel telemedical approach will be introduced and investigated. STUDY DESIGN:In a prospective randomised multi-centre study, 180 patients with stable symptomatic HFpEF will be randomised (1:1:1) to moderate intensity continuous training, high intensity interval training, or a control group. The training intervention includes three months supervised followed by nine months of telemedically monitored home-based training. The primary endpoint is change in exercise capacity, defined as change in peak oxygen uptake (VO2peak) after three months, assessed by cardiopulmonary exercise testing. Secondary endpoints include diastolic filling pressure (E/e') and further echocardiographic and cardiopulmonary exercise testing (CPX) parameters, biomarkers, quality of life and endothelial function. Training sessions and physical activity will be monitored and documented throughout the study with accelerometers and heart rate monitors developed on a telemedical platform for the OptimEx-CLIN study. Inclusion of patients started in July 2014, first results are expected in 2017.

journal_name

Eur J Prev Cardiol

authors

Suchy C,Massen L,Rognmo O,Van Craenenbroeck EM,Beckers P,Kraigher-Krainer E,Linke A,Adams V,Wisløff U,Pieske B,Halle M

doi

10.1177/2047487314552764

subject

Has Abstract

pub_date

2014-11-01 00:00:00

pages

18-25

issue

2 Suppl

eissn

2047-4873

issn

2047-4881

pii

21/2_suppl/18

journal_volume

21

pub_type

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