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

Eur J Prev Cardiol. 2014 Nov;21(2 Suppl):18-25. doi: 10.1177/2047487314552764.


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.

Trial registration: ClinicalTrials.gov NCT02078947.

Keywords: Heart failure; diastolic heart failure; exercise capacity; exercise training; heart failure with preserved ejection fraction; interval training; telemonitoring; training intensity.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Actigraphy
  • Electrocardiography
  • Europe
  • Exercise Test
  • Exercise Therapy*
  • Exercise Tolerance
  • Heart Failure, Diastolic / diagnosis
  • Heart Failure, Diastolic / physiopathology
  • Heart Failure, Diastolic / prevention & control*
  • Heart Failure, Diastolic / therapy*
  • Heart Rate
  • Humans
  • Predictive Value of Tests
  • Preventive Health Services / methods*
  • Prospective Studies
  • Recovery of Function
  • Research Design*
  • Signal Processing, Computer-Assisted
  • Stroke Volume
  • Telemedicine* / instrumentation
  • Telemetry* / instrumentation
  • Time Factors
  • Transducers
  • Treatment Outcome
  • Ventricular Function, Left

Associated data

  • ClinicalTrials.gov/NCT02078947