Reproducibility of measurement of skeletal muscle tissue oxygenation in patients with chronic heart failure.

Reproducibility of measurement of skeletal muscle tissue saturation index in patients with chronic heart failure.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON19931

Enrollment

Registered

2011-12-15

Start date

2012-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Chronic Heart Failure, Exercise intolerance, Skeletal muscle impairment. Chronisch hartfalen, inspanningsintolerantie, skeletspierbeperking

Interventions

The study is designed as a prospective observational study without invasive measurements. After informed consent is obtained, a baseline assessment will be performed. The first part of this assessment

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent; 2. Systolic heart failure secondary to ischemic or dilated cardiomyopathy; 3. New York Heart Association (NYHA) class II or III (without change in class or medication < 3 months prior to inclusion); 4. Left ventricular ejection fraction of ≤ 40% (assessed within 3 months before inclusion by echocardiography, MRI or radionuclear measurement).

Exclusion criteria

Exclusion criteria: 1. Myocardial infarction or unstable angina less than 3 months prior to inclusion; 2. Clinical signs of decompensated heart failure; 3. Ventricular tachycardia or ischemia during exercise; 4. Participation in a training program (≥ 2/week) in the last year; 5. Intracardiac shunts or congenital heart disease limiting exercise capacity; 6. Orthopaedic, vascular, pulmonary, neuromuscular and other disease limiting exercise capacity.

Design outcomes

Primary

Measure	Time frame
Difference (paired T-test when normally distributed) and agreement (intra-class correlation coefficients, limits of agreement and coefficients of variation) of the rate of muscle deoxygenation at exercise onset between two days (rate of decrease of muscle tissue saturation index expressed as MRT-TSI).	—

Secondary

Measure	Time frame
Difference (independent T-test when normally distributed) of VO2 kinetics (rate of increase in VO2 after onset of submaximal exercise expressed as ô-VO2) and NIRS kinetics (MRT-TSI) between healthy subjects and CHF patients during the first submaximal exercise test.	—

Contacts

Public ContactV. Niemeijer

Postbus 7777

v.niemeijer@mmc.nl+31 (0)40 88888200

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)