Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07130968

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

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).

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

MACE Brain Diseases Cardiac Death Cardiac Rehospitalization Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Death Nervous System Diseases Non-fatal Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Unplanned Repeat Revascularization Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).
  • Conditions potentially exacerbated by exercise (e.g., acute cardiac insufficiency, exercise-induced asthma, epilepsy).
  • Physical disability due to musculoskeletal or neuromuscular disorders.
  • Pregnancy or lactation.
  • Patients deemed unsuitable for participation by the investigator.

Treatment and study plan

Primary outcomes

  1. Characteristics of CPET parameters across different cardiovascular diseases.

    Time frame: After enrollment

    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.

  2. Incidence of 5-year MACE

    Time frame: from enrollment to 5 years post-enrollment

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

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

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

  • Dongguan Binhaiwan Central Hospital
  • Gansu Provincial Hospital
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Nanfang Hospital, Southern Medical University
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • Shenzhen Center for Chronic Disease Control
  • Third Affiliated Hospital, Sun Yat-Sen University
  • Yuebei People's Hospital
  • Zhengzhou Central Hospital
  • Zhongshan Hospital Of Traditional Chinese Medicine

Registry information

Acronym: China-CPET

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Aug 19, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.