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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
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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

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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
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In context

Death

456 studies on the registry are indexed under Death; 86 are open to participants now.

This study's planned enrollment of 200,000 is above the median of 400 across 236 observational studies indexed under Death.

Browse Death studies →

Lead sponsor

Guangdong Provincial People's Hospital is the lead sponsor of 237 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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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
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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

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Study locations

1 site
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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

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Dec 2035, 130 months after the start.

Of 84 non-industry observational studies under Death, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 245. This study's planned 130 months is above that.

Counting every sponsor, half of 87 studies reached it within 60 months; a quarter within 23 and three quarters within 245.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2025
First posted
Aug 19, 2025
StartActual
Feb 1, 2025
Primary completionEst.
Dec 30, 2035
CompletionEst.
Dec 30, 2035
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07130968
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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