1. To compare the impact of a 12-month cardiac rehabilitation program (PRO-FIT) vs. an invasive approach including coronary angiography and subsequent coronary revascularization in stable angina pectoris patients on angina symptoms.2. To evaluate…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the quantity of angina symptoms (evaluated by the
SAQ-7) following the 12-month intervention.
Secondary outcome
Secondary outcomes include cost-effectiveness, the ischemic threshold during
exercise, cardiovascular events, quality of life, fitness, cardiovascular
health and psychosocial wellbeing.
Background summary
Stable angina pectoris (SAP) is a highly common condition in the Netherlands.
Despite optimal medical treatment patients often remain symptomatic and at risk
for cardiovascular morbidity and mortality. In daily practice often an invasive
strategy is applied in these patients consisting of coronary angiography and
subsequent coronary revascularization by percutaneous coronary intervention
(PCI) or coronary artery bypass grafting (CABG). However, in a large recent
trial and meta-analysis, this costly and invasive procedure did not show
beneficial effects on symptoms or prognosis in patients with SAP.
An important reason for the high disease burden in these patients might be the
non-adherence to healthy lifestyle advices. The potential of lifestyle-related
interventions such as cardiac rehabilitation on progression of coronary artery
disease is well-known but contemporary RCT*s comparing cardiac rehabilitation
with coronary revascularization are lacking. To optimize the long-term clinical
effects and wide-scale implementation, these interventions should have a sound
physiological basis, be personalized to a patients* needs and preferences,
include effective behavioural change strategies and be easily accessible in the
current healthcare system.
Study objective
1. To compare the impact of a 12-month cardiac rehabilitation program (PRO-FIT)
vs. an invasive approach including coronary angiography and subsequent coronary
revascularization in stable angina pectoris patients on angina symptoms.
2. To evaluate the cost-effectiveness of PRO-FIT compared to routine invasive
care in stable angina pectoris patients, as well as cardiovascular events,
quality of life, fitness, cardiovascular health, psychosocial wellbeing.
Study design
Multicenter randomized controlled trial
Intervention
A 12-month cardiac rehabilitation program (PRO-FIT) aiming at angina relief and
sustainable behavioural change for long-lasting improvement in cardiovascular
health. PRO-FIT will consist of multiple lifestyle interventions including an
exercise program and a dietary intervention with a stepped decline in guidance
by health care professionals to encourage the sustainability of behavioural
change.
Study burden and risks
Recent studies show that routine invasive care does not result in superior
effects on re-events or prognosis as compared to non-invasive medical
treatment, showing that a conservative approach is safe in patients with SAP.
In the PRO-FIT study, the intervention group will receive cardiac
rehabilitation on top of medical treatment, which may be perceived as
burdensome by some patients, because it requires time and effort from the
patients. However, the cardiac rehabilitation program is expected to be
beneficial. According to several studies, event rates of exercise training in
cardiac patients are approximately 1:50.000 to 1:60.000 exercise hours/year,
due to this low number of event rates we expect no additional risks of the
intervention.
The extra measurements for this study on top of regular care consist of an
exercise test at one-year follow-up and questionnaires every 3 months. These
measurements are all minimally invasive and also routinely performed in regular
care. Therefore, the nature and extend of the burden and risks associated with
study participation are very low.
The control group will receive usual care.
If a patient from the intervention group has signs of clinically worsening
symptoms, the patient will be thoroughly evaluated and will receive additional
care as needed, whereby also crossover to usual care (i.e. invasive evaluation
with a coronary angiogram) will be considered as appropriate.
De Run 4600
Velhoven 5500 MB
NL
De Run 4600
Velhoven 5500 MB
NL
Listed location countries
Age
Inclusion criteria
- Stable angina pectoris with residual anginal symptoms after optimal medical
therapy
- Established ischemia (assessed by SPECT, PET, stress ultrasound, CMR, or
cycle ergometry)
- Access to a personal computer, laptop or tablet with internet connectivity at
home
- Access to a mobile phone with short message service (SMS) functionality to
login to the web application with two-factor authentication
Exclusion criteria
An echocardiography and coronary angiography (usual care group) or coronary
computed tomography (CT)-angiography (cardiac rehabilitation group) will be
performed at baseline to exclude high-risk patients with a reduced left
ventricular function (i.e. left ventricular ejection fraction <35%) or left
main coronary artery disease. For these patients previous work revealed the
potential prognostic benefit of revascularization, in terms of mortality, also
supported by latest guidelines on myocardial revascularization with a class 1A
indication for revascularization.
Other exclusion criteria include:
1. PCI or CABG in the past year
2. Acute coronary syndrome in past 2 months
3. Angina symptoms at rest or rapidly progressive (i.e. unstable angina)
4. Ischemic threshold <50 watts
5. New-York Heart Association class III-IV heart failure symptoms
6. Advanced chronic kidney failure (i.e. estimated Glomerular Filtration rate
<30ml/min)
7. Severe ventricular arrhythmia or exercise-induced arrythmia at baseline
testing
8. A comorbidity precluding exercise training (e.g. orthopaedic, neurological
or cognitive conditions) or other contra-indications for exercise training.
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 |
|---|---|
| CCMO | NL77210.091.21 |