Exercise-related predictors of cardiac resynchronization therapy

Exercise-related predictors of cardiac resynchronization therapy - 'The EXERCISE trail'

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40869

Enrollment

100

Registered

2014-10-06

Start date

2016-02-04

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: heart failure NYHA class III accepted for CRT, according to current guidelines left ventricular ejection fraction

Exclusion criteria

Exclusion criteria: Myocardial infarction or unstable angina less than 3 months prior to inclusion Clinical signs of decompensated heart failure Ventricular tachycardia or ischemia during exercise Intra cardiac shunts or congenital heart disease limiting exercise capacity Orthopaedic, vascular, pulmonary, neuromuscular and other disease limiting exercise capacity in a way that performing exercise tests is not feasible

Design outcomes

Primary

Measure	Time frame
Correlation between exercise-related central hemodynamic and extra-cardiac parameters at baseline and the response to CRT, using logistic regression. Response to CRT is defined as a decline in end systolic left ventricular volume of at least 15% and/or increase of left ventricular ejection fraction (LVEF) of > 5%. Potential central hemodynamic predictors are assessed by exercise echocardiography (mitral regurgitation, LV volumes and intraventricular dyssynchrony) and radial artery pulse contour analysis (cardiac output). Potential extra cardiac predictors include peak oxygen uptake, oxygen uptake efficiency slope and kinetics of recovery of skeletal muscle oxygenation after sub maximal exercise using Near Infrared Spectroscopy.	—

Measure

Time frame

Correlation between exercise-related central hemodynamic and extra-cardiac parameters at baseline and the response to CRT, using logistic regression. Response to CRT is defined as a decline in end systolic left ventricular volume of at least 15% and/or increase of left ventricular ejection fraction (LVEF) of > 5%. Potential central hemodynamic predictors are assessed by exercise echocardiography (mitral regurgitation, LV volumes and intraventricular dyssynchrony) and radial artery pulse contour analysis (cardiac output). Potential extra cardiac predictors include peak oxygen uptake, oxygen uptake efficiency slope and kinetics of recovery of skeletal muscle oxygenation after sub maximal exercise using Near Infrared Spectroscopy.

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Secondary

Measure	Time frame
None	—

Countries

Netherlands

Outcome results