The main objectives of this study are to evaluate the effects of HIT in CHF patients on cardiac output at rest assessed with cardiac magnetic resonance imaging(cMRI), and to investigate the relation between changes in resting cardiac output and…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
1. Training induced changes in resting cardiac output as determined by cMRI.
2. Correlation between training induced changes in resting cardiac output and
cardiac output during maximal exercise (LiDCO).
Secondary outcome
Secondary endpoints:
Correlation between training induced changes in resting c.q. exercizing
cardiac output and changes in the following variables:
* Cardiac size at rest (cMRI)
* Cardiac output onset and recovery kinetics at submaximal exercise (LiDCO)
* Recovery kinetics of muscle tissue oxygenation after submaximal exercise
(Near Infrared Spectroscopy)
* Quality of life (Minnesota Living With Heart Failure Questionnaire)
Background summary
Physical training has beneficial effects on exercise capacity, cardiac
function, quality of life and mortality in patients with chronic heart failure
(CHF). However, the optimal training mode and intensity are not yet
established.
In a recent small trial in elderly CHF patients, high intensity interval
training (HIT) was shown to be superior to moderate intensity exercise
training. Whereas both training modalities resulted in improved skeletal muscle
metabolism and perfusion, HIT also induced improvements in cardiac function and
size. However, as cardiac function was assessed at rest only, and measurements
were performed by 2D echocardiography, which has limited accuracy for this
purpose in patients with remodeled hearts, definitive conclusions cannot be
drawn from this study.
Study objective
The main objectives of this study are to evaluate the effects of HIT in CHF
patients on cardiac output at rest assessed with cardiac magnetic resonance
imaging(cMRI), and to investigate the relation between changes in resting
cardiac output and changes in cardiac output during maximal exercise (assessed
by LiDCO). Secondary objectives are to investigate the relation between
training-induced changes in central haemodynamics and changes in the following
variables: cardiac size at rest, cardiac output kinetics during and after
submaximal exercise, local oxygen delivery in skeletal muscles and quality of
life
Study design
prospective randomised controlled intervention trial
Intervention
HIT is performed 3 times a week during 12 weeks and consists of 4 intervals of
4 minutes cycling on a ergometer at 85-95% of the peak aerobic capacity (peak
Vo2) separated by 3 minute active pauses. The entire program is performed in
the hospital under direct supervision of trained physiotherapists.
Study burden and risks
Exercise training performed by patients with chronic heart failure patients is
considered to be safe and has a class Ia recommendation for treatment of CHF
patients.
The HIT program that will be used in this study has been evaluated in a
similar population of elderly CHF patients and also in patients with coronary
artery disease without any documented harmful effects. In order to reduce
potential risks of exercise training all patients perform a maximal
cardiopulmonary exercise test at baseline, excluding patients with myocardial
ischaemia and ventricular arrhythmias during exercise. Training sessions will
be under supervision of trained physiotherapist in a clinical setting.
Regarding the study procedures:
Cardiac output during exercise is evaluated by using a method (LIDCO) requiring
radial artery cannulation. Radial artery canulation is considered to be
relatively safe with complication rate of 0.09% for permanent ischemia of the
hand. To ensure collateral circulation a normal Allen test must be present.
Puncture will be under local anaesthesia to minimize patients burden. In
patients who take oral anticoagulation , dosage will be temporarily adjusted
(INR <1,5) for the safety of the procedure. Patients will be screened for
contra indications before cardiac MRI.
de run 4600
5504 DB Veldhoven
NL
de run 4600
5504 DB Veldhoven
NL
Listed location countries
Age
Inclusion criteria
* Written informed consent.
* Systolic heart failure due to ischemic cardiomyopathy (due to one or more myocardial infarction, as confirmed with echocardiography) or dilating cardiomyopathy (no history of myocardial infarction, no proven ischemia, no congenital heart disease en no severe valve disorder)
* Left ventricular ejection fraction (LVEF) * 40% (assessed within 3 months before inclusion by echocardiography, MRI or radionuclear measurement)
* New York Heart Association (NYHA) class II or III
* Optimal medical treatment
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
* Participation in a training program (*2/week) in the last year
* Intracardiac shunts or congenital heart disease limiting exercise capacity
* Orthopaedic, vascular, pulmonary, neuromuscular and other disease limiting exercise capacity in a way that the training program is not feasible.
* Pathological Allen test , In casu no sufficient collateral circulation to the hand, in case of radial artery cannulation.
*MRI will not be part of the studyprotocol in eligible patients with pacemaker/ICD or other contra indications for MRI
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | 3041 |
| CCMO | NL37770.015.11 |
| OMON | NL-OMON28867 |