Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease

Cardiac Rehabilitation Clinical Trial

Official title:

Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05320848
• Other study ID #: SY-CSF-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 1, 2025

Study information

• Verified date: April 2022
• Source: Shenzhen People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: February 1, 2025
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Cardiovascular Diseases

Intervention

Behavioral:
• cardiac rehabilitation
Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease.

Locations

Country	Name	City	State
China	Shenzhen People's Hospital	Shenzhen

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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;(1):CD001800. doi: 10.1002/14651858.CD001800.pub3. Review. Update in: Cochrane Database Syst Rev. 2021 Nov 6;11:CD001800. — View 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. Review. — View 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. Review. — View Citation

Ruano-Ravina A, Pena-Gil C, Abu-Assi E, Raposeiras S, van 't Hof A, Meindersma E, Bossano Prescott EI, González-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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first occurrence of major adverse cardiovascular events (MACE)	first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization)	3 years
Primary	maximum oxygen uptake	maximum oxygen uptake	3 years