Clinical trial NCT00411359: Cardiac Rehabilitation for the Treatment of Refractory Angina
Official title: Cardiac Rehabilitation for the Treatment of Refractory Angina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Angina Pectoris
Coronary Disease
Keywords: Refractory angina
Cardiac rehabilitation
Symptomology
Physical ability
Exercise
Psychology
Quality of life
Risk factors
Lead sponsor: National Heart and Lung Institute
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: Royal Brompton & Harefield NHS Foundation Trust
First posted: 2006-12-14
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether cardiac rehabilitation is a successful treatment for refractory angina, in relation to improvements in cardiovascular risk factors, physical ability, symptomology, quality of life and psychological morbidity.

Detailed description: The majority of patients presenting with angina pectoris resulting from coronary artery disease (CHD) are successfully treated with interventions including coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA) and medical management. However, a growing number of patients experience persistent angina in spite of intervention and optimal medical treatment. Such patients are referred to as suffering from 'refractory angina'.

Currently, cardiac rehabilitation centres are reluctant to accept patients with ongoing angina or complicated cardiovascular history, in spite of the duration or stability of the symptoms. Indeed, angina and heart failure are often used to exclude patients from cardiac rehabilitation. However, in the recent updated American Heart Association (AHA) recommendations for exercise and training, cardiac rehabilitation and supervised exercise training is recommended for patients with ongoing angina, previous history of CABG, MI, PTCA and patients with existing cardiomyopathy in order to promote a reduction in myocardial ischaemia at rest and during sub-maximal exercise, while reducing the risk for the progression of CHD. Nevertheless, studies exploring the physiological and psychological impact of routinely available CR as a stand-alone intervention among refractory angina patients have not previously been undertaken. Until such studies are performed, CR practitioners will continue to refuse to accept refractory angina patients for participation in CR.

Research questions:

* Is an eight-week cardiac rehabilitation exercise programme an appropriate treatment option for patients with refractory angina?
* Does an eight-week cardiac rehabilitation exercise programme improve the physical functioning and cardiovascular health of patients with refractory angina?
* Is symptom severity and frequency reduced following an eight-week cardiac rehabilitation exercise programme in patients with refractory angina?
* Does an eight-week cardiac rehabilitation exercise programme have any impact on anxiety, depression, cardiac anxiety and quality of life in patients with refractory angina?
* Are any physiological or psychological effects acquired by patients with refractory angina participating in a cardiac rehabilitation exercise programme maintained at an eight-week follow-up?

The study is conceived as a randomised intervention-control study of a standard, routinely available Phase III hospital-based CR program among patients with refractory angina. Patients will be randomly assigned to an eight-week CR programme based at Harefield Hospital or symptom diary monitoring control group.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with refractory angina \> 6 months
* Two or more episodes of angina per week
* Males and females aged 30 - 80
* Previous history of single or multiple myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or any combination of the above
* Prescribed optimal medical therapy
* AHA exercise and training guidelines classification B and C
* Willing to give written informed consent

Exclusion Criteria:

* History of any other chronic illness
* AHA exercise and training guidelines classification class D
* Suffer any physical condition for which exercise is a contra-indication
* Participation in two or more periods of planned moderate intensity exercise per week during the past 6 months
* Participation in another research study within the previous 60 days
* History of psychiatric illness
* Unwilling to give written informed consent

Primary outcomes:
measure: Health anxiety
timeFrame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
measure: Generalised anxiety and depression
timeFrame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Secondary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
measure: Heart rate
timeFrame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
measure: Anthropomometry
timeFrame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
measure: Fasting lipids
timeFrame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
measure: Social support
timeFrame: Baseline
measure: Angina related health beliefs
timeFrame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
measure: Physical activity and exercise capacity
timeFrame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
measure: Angina frequency and severity
timeFrame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
measure: Quality of life
timeFrame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
measure: Plasma glucose
timeFrame: Base, post intervention/monitoring, 8 weeks post intervention/monitoring
measure: Urea & electrolytes
timeFrame: Base, post intervention/monitoring, 8 weeks post intervention/monitoring
measure: Liver function tests
timeFrame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
measure: Thyroid function tests
timeFrame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
measure: Hb
timeFrame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
measure: HbA1C (if diabetic)
timeFrame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: National Heart and Lung Institute, Imperial College London
Study officials:
affiliation: National Heart and Lung Institute, Imperial College London
name: Peter Collins, MA, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Kim Fox, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Mahmud Barbir, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mannheimer C, Camici P, Chester MR, Collins A, DeJongste M, Eliasson T, Follath F, Hellemans I, Herlitz J, Luscher T, Pasic M, Thelle D. The problem of chronic refractory angina; report from the ESC Joint Study Group on the Treatment of Refractory Angina. Eur Heart J. 2002 Mar;23(5):355-70. doi: 10.1053/euhj.2001.2706. No abstract available.
citation: DeJongste MJ, Tio RA, Foreman RD. Chronic therapeutically refractory angina pectoris. Heart. 2004 Feb;90(2):225-30. doi: 10.1136/hrt.2003.025031. No abstract available.
citation: Gowda RM, Khan IA, Punukollu G, Vasavada BC, Nair CK. Treatment of refractory angina pectoris. Int J Cardiol. 2005 May 11;101(1):1-7. doi: 10.1016/j.ijcard.2004.03.066.
citation: Chester M, Hammond C, Leach A. Long-term benefits of stellate ganglion block in severe chronic refractory angina. Pain. 2000 Jul;87(1):103-105. doi: 10.1016/S0304-3959(00)00270-0.
citation: Stewart S. Refractory to medical treatment but not to nursing care: can we do more for patients with chronic angina pectoris? Eur J Cardiovasc Nurs. 2003 Sep;2(3):169-70. doi: 10.1016/S1474-5151(03)00067-7. No abstract available.
citation: Moore RK, Groves D, Bateson S, Barlow P, Hammond C, Leach AA, Chester MR. Health related quality of life of patients with refractory angina before and one year after enrolment onto a refractory angina program. Eur J Pain. 2005 Jun;9(3):305-10. doi: 10.1016/j.ejpain.2004.07.013.
citation: Lear SA, Ignaszewski A. Cardiac rehabilitation: a comprehensive review. Curr Control Trials Cardiovasc Med. 2001;2(5):221-232. doi: 10.1186/cvm-2-5-221.
citation: Hevey D, Brown A, Cahill A, Newton H, Kierns M, Horgan JH. Four-week multidisciplinary cardiac rehabilitation produces similar improvements in exercise capacity and quality of life to a 10-week program. J Cardiopulm Rehabil. 2003 Jan-Feb;23(1):17-21. doi: 10.1097/00008483-200301000-00004.
citation: Grace SL, Abbey SE, Shnek ZM, Irvine J, Franche RL, Stewart DE. Cardiac rehabilitation I: review of psychosocial factors. Gen Hosp Psychiatry. 2002 May-Jun;24(3):121-6. doi: 10.1016/s0163-8343(02)00178-0.
citation: Grace SL, Abbey SE, Shnek ZM, Irvine J, Franche RL, Stewart DE. Cardiac rehabilitation II: referral and participation. Gen Hosp Psychiatry. 2002 May-Jun;24(3):127-34. doi: 10.1016/s0163-8343(02)00179-2.
citation: Johnston M, Foulkes J, Johnston DW, Pollard B, Gudmundsdottir H. Impact on patients and partners of inpatient and extended cardiac counseling and rehabilitation: a controlled trial. Psychosom Med. 1999 Mar-Apr;61(2):225-33. doi: 10.1097/00006842-199903000-00015.
citation: Yoshida T, Kohzuki M, Yoshida K, Hiwatari M, Kamimoto M, Yamamoto C, Meguro S, Endo N, Kato A, Kanazawa M, Sato T. Physical and psychological improvements after phase II cardiac rehabilitation in patients with myocardial infarction. Nurs Health Sci. 1999 Sep;1(3):163-70. doi: 10.1046/j.1442-2018.1999.00021.x.
citation: Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Pina IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001 Oct 2;104(14):1694-740. doi: 10.1161/hc3901.095960. No abstract available.
citation: Taylor RS, Brown A, Ebrahim S, Jolliffe J, Noorani H, Rees K, Skidmore B, Stone JA, Thompson DR, Oldridge N. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004 May 15;116(10):682-92. doi: 10.1016/j.amjmed.2004.01.009.
citation: Asbury EA, Creed F, Collins P. Distinct psychosocial differences between women with coronary heart disease and cardiac syndrome X. Eur Heart J. 2004 Oct;25(19):1695-701. doi: 10.1016/j.ehj.2004.07.035.
citation: Asbury EA, Webb CM, Probert H, Wright C, Barbir M, Fox K, Collins P. Cardiac rehabilitation to improve physical functioning in refractory angina: a pilot study. Cardiology. 2012;122(3):170-7. doi: 10.1159/000339224. Epub 2012 Jul 27.