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Enrolling by invitationNCT07130968China-CPETUpdated Apr 29, 2026

Real-World Cohort Study of Cardiopulmonary Function in Chinese Patients With Cardiovascular Disease: CPET Evaluation and Five-Year Prognostic Follow-Up Based on a Multicenter Structured Data Platform

An observational study in MACE, Cardiac Death and Unplanned Repeat Revascularization, sponsored by Guangdong Provincial People's Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Guangdong Provincial People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200,000
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The goal of this observational study is to observe the characteristics of cardiopulmonary exercise testing (CPET) parameters in patients across different cardiovascular diseases and to evaluate the predictive value of multiparameter cardiopulmonary indices for 5-year major adverse cardiovascular events (MACE).

Read the detailed description

To investigate the CPET characteristics in patients with various cardiovascular diseases (including acute myocardial infarction, heart failure, cardiomyopathy, valvular heart disease, coronary artery disease, and perioperative cardiac surgery), with annual follow-up of major adverse cardiovascular events (MACE) for five years, and to establish the predictive value of combined CPET parameters for MACE in this population

02

Conditions studied

  • MACE
  • Cardiac Death
  • Unplanned Repeat Revascularization
  • Cardiac Rehospitalization
  • Non-fatal Myocardial Infarction
  • Stroke

Keywords

  • Cardiopulmonary Exercise Testing
  • Cardiovascular Diseases
  • Major Adverse Cardiovascular Events (MACE)
  • Prognosis
  • Exercise Capacity
  • Cardiorespiratory Fitness
  • Clinical Outcomes
  • Real-world Study
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

China CardioVascular Disease Patient and healthy control group

Inclusion criteria

  1. Age: 18-80 years,
  2. Ability to comprehend and provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Comorbid severe conditions (e.g., recent acute myocardial infarction, unstable angina, uncontrolled arrhythmias, severe aortic coarctation or descending aortic aneurysm, acute myocarditis or pericarditis, acute congestive heart failure, acute respiratory failure, resting oxygen saturation \<93%, recent arterial or pulmonary embolism, pulmonary edema).
  2. Conditions potentially exacerbated by exercise (e.g., acute cardiac insufficiency, exercise-induced asthma, epilepsy).
  3. Physical disability due to musculoskeletal or neuromuscular disorders.
  4. Pregnancy or lactation.
  5. Patients deemed unsuitable for participation by the investigator.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • cardiovascular disease patient with MACE

    cardiovascular disease patient with MACE(Cardiac death, unplanned revascularization, cardiac readmission, non-fatal myocardial infarction, and stroke)

  • cardiovascular disease patient without MACE
05

What researchers measure

Primary outcomes

  1. Characteristics of CPET parameters across different cardiovascular diseases.

    Cardiopulmonary exercise testing (CPET) was performed using exercise cardiopulmonary testing systems from VYAIRE (Germany) and SCHILLER (Switzerland). A symptom-limited maximal exercise test with a 1-minute ramp incremental protocol (Ramp protocol) was adopted, designed to complete the workload test within 8-12 minutes according to the incremental power calculation formula. The incremental workload was calculated as follows: Unloaded VO₂ (ml/min) per minute = 150 + (6 × body weight) Predicted peak VO₂max (ml/min) per minute for males = (height in cm - age in years) × 20 Predicted peak VO₂max (ml/min) per minute for females = (height in cm - age in years) × 14 Incremental power per minute = (predicted peak VO₂max - unloaded VO₂)/100 During exercise, real-time cardiopulmonary parameters were collected, including peak oxygen uptake (VO₂peak), anaerobic threshold (AT), maximal cycling workload, respiratory rate, minute ventilation (VE), and ventilatory efficiency, among others.

    Time frame: After enrollment

  2. Incidence of 5-year MACE

    MACE (cardiovascular death, unplanned repeat revascularization, cardiac rehospitalization, non-fatal myocardial infarction, stroke)

    Time frame: from enrollment to 5 years post-enrollment

Secondary outcomes

  1. Incidence of individual events of MACE per year (incidence of cardiac death, unplanned rereconstitution, cardiac rehospitalization, nonfatal myocardial infarction, and stroke)

    Time frame: yearly for 5 years (Year 1/2/3/4/5 from enrollment)

Other outcomes

  1. Incidence rate of adverse events during exercise

    Time frame: During each exercise session and within 24 hours after exercise

06

Study locations

1 site
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong, China
07

References and documents

Publications

  • Shephard RJ, Balady GJ. Exercise as cardiovascular therapy. Circulation. 1999 Feb 23;99(7):963-72. doi: 10.1161/01.cir.99.7.963. No abstract available. PubMed 10027821 ↗
  • Fiuza-Luces C, Santos-Lozano A, Joyner M, Carrera-Bastos P, Picazo O, Zugaza JL, Izquierdo M, Ruilope LM, Lucia A. Exercise benefits in cardiovascular disease: beyond attenuation of traditional risk factors. Nat Rev Cardiol. 2018 Dec;15(12):731-743. doi: 10.1038/s41569-018-0065-1. PubMed 30115967 ↗
  • DeCato TW, Haverkamp H, Hegewald MJ. Cardiopulmonary Exercise Testing (CPET). Am J Respir Crit Care Med. 2020 Jan 1;201(1):P1-P2. doi: 10.1164/rccm.2011P1. No abstract available. PubMed 31891317 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07130968
Lead sponsor
Guangdong Provincial People's Hospital
Collaborators
Yuebei People's Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Gansu Provincial Hospital, Shenzhen Center for Chronic Disease Control, Guangdong Provincial Hospital of Traditional Chinese Medicine, Nanfang Hospital, Southern Medical University, Third Affiliated Hospital, Sun Yat-Sen University, Zhongshan Hospital Of Traditional Chinese Medicine, Zhengzhou Central Hospital, Dongguan Binhaiwan Central Hospital
Responsible party
Huan Ma (Deputy Director of Cardiology, Director of the Department of Cardiac Rehabilitation, Guangdong Provincial People's Hospital) — Principal investigator
First posted
Aug 19, 2025
Start date
Feb 1, 2025
Primary completion
Dec 30, 2035 (estimated)
Completion
Dec 30, 2035 (estimated)
Last update
Apr 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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