Clinical trial NCT05320848: Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease
Official title: Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Rehabilitation
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease. Current guidelines support its use in patients after acute coronary syndrome, coronary artery bypass grafting, coronary stent placement, valve surgery, and stable chronic systolic heart failure. Its use in these conditions is supported by a robust body of research demonstrating improved clinical outcomes. Despite this evidence, cardiac rehabilitation referral and attendance remains low and interventions to increase its use need to be developed.

Detailed description: The trial was conducted in Shenzhen in China. This study will recruit 100 patients with cardiovascular disease with a median and minimum follow-up of 24 and 6 months. Patients will be individually randomized to receive either a cardiac rehabilitation program (n = 50) or enhanced standard care involving educational advice (n = 50). The co-primary outcomes are: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the Quality of Life-5 Dimensions-5 Level visual analogue scale.

Eligibility criteria: Inclusion Criteria:

* Cardiovascular disease

Exclusion Criteria:

* Incalculable TFC
* Coronary artery spasm or ectasia
* LV ejection fraction \< 52% in males or \< 54% in females
* Abnormal heart structure (congenital heart disease, cardiomyopathies, or valvular dysfunction)
* Pericardial disease (pericardial effusion or constrictive pericarditis)
* Previous history of myocardial infarction
* Uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 105 mmHg)
* Hyperthyroidism
* Hypothyroidism
* Malignancy
* Autoimmune disease
* Infection
* Pulmonary, hepatic, and renal disorders
* Haematological disorders (anaemia, bone marrow involved by neoplastic disease, or red blood cell transfusions)

Primary outcomes:
measure: first occurrence of major adverse cardiovascular events (MACE)
timeFrame: 3 years
measure: maximum oxygen uptake
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
Study officials:
References:
citation: Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.
citation: Ruano-Ravina A, Pena-Gil C, Abu-Assi E, Raposeiras S, van 't Hof A, Meindersma E, Bossano Prescott EI, Gonzalez-Juanatey JR. Participation and adherence to cardiac rehabilitation programs. A systematic review. Int J Cardiol. 2016 Nov 15;223:436-443. doi: 10.1016/j.ijcard.2016.08.120. Epub 2016 Aug 13.
citation: Wong WP, Feng J, Pwee KH, Lim J. A systematic review of economic evaluations of cardiac rehabilitation. BMC Health Serv Res. 2012 Aug 8;12:243. doi: 10.1186/1472-6963-12-243.
citation: Ragupathi L, Stribling J, Yakunina Y, Fuster V, McLaughlin MA, Vedanthan R. Availability, Use, and Barriers to Cardiac Rehabilitation in LMIC. Glob Heart. 2017 Dec;12(4):323-334.e10. doi: 10.1016/j.gheart.2016.09.004. Epub 2017 Mar 13.
citation: Edwards K, Jones N, Newton J, Foster C, Judge A, Jackson K, Arden NK, Pinedo-Villanueva R. The cost-effectiveness of exercise-based cardiac rehabilitation: a systematic review of the characteristics and methodological quality of published literature. Health Econ Rev. 2017 Oct 19;7(1):37. doi: 10.1186/s13561-017-0173-3.