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RecruitingNCT06954727CHA-RHCUpdated May 21, 2025

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization

An observational study in Pulmonary Hypertension, Pulmonary Embolism (Diagnosis) and Pulmonary Arterial Hypertension, sponsored by China-Japan Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.

Primary conditionPulmonary Arterial HypertensionRegistry: Hypertension, PulmonaryReclassifiedWhy we changed it
Registry
Hypertension, Pulmonary — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pulmonary Arterial Hypertension
Why
  1. The study's listed conditions name Pulmonary Arterial Hypertension, a narrower term within Hypertension, Pulmonary.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by China-Japan Friendship Hospital · Observational

From the registry’s dates

  • Started Jan 2018; still recruiting 8 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
14 Years and older
Sex
All
01

Study summary

Right heart catheterization(RHC) plays a crucial role in the diagnosis and treatment of pulmonary vascular diseases(PVD). In China, the lack of equipment and technical expertise has historically limited the implementation of RHC, thereby greatly restricting the diagnosis and treatment of RVD. In recent years, with improvements in these issues, more hospitals have acquired the capability to perform RHC. The purpose of this study is to conduct quality control of RHC across multiple pulmonary hypertension(PH) centers in China. The study population consists of patients who underwent RHC for the first time due to dyspnea or suspected PH. This study retrospectively and prospectively collects multicenter RHC data, with the main quality control contents including indications for the procedure, collection and analysis of hemodynamic data, diagnosis and treatment, and long-term management of patients.

Read the detailed description

This study is led by the China-Japan Friendship Hospital and will be conducted across approximately 30 pulmonary hypertension centers in China. It is an observational cohort study without interventional treatment. Eligible participants are patients aged 14 years or older who undergo right heart catheterization due to dyspnea or suspected pulmonary hypertension. After study initiation, investigators at each center will enroll eligible patients and collect baseline data, hemodynamic parameters from right heart catheterization, diagnostic classification of pulmonary hypertension, and treatment plans. Patients will receive routine follow-up at their respective centers, and investigators will gather follow-up data according to the study protocol. All de-identified data will be recorded in an Electronic Data Capture (EDC) system. A dedicated data management team will oversee data management, quality control, and statistical analysis.

02

Conditions studied

  • Pulmonary Hypertension
  • Pulmonary Embolism (Diagnosis)
  • Pulmonary Arterial Hypertension
  • Right Heart Catheterization

Keywords

  • right heart catheterization
  • pulmonary hypertension
  • pulmonary arterial hypertension
  • pulmonary vascular disease
03

In context

Pulmonary Arterial Hypertension Reclassified

699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 104 across 181 observational studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 178 studies on the registry; 111 are open to participants now.

Compared within Pulmonary Arterial Hypertension, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypertension, Pulmonary. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension and age over 14 years old

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

  • Patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension
  • Age ≥14 years old

Exclusion criteria

Exclusion Criteria:

  • Vital data missing
  • Did not sign or did not agree to follow-up
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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients who underwent right heart catheterization

    The study population consists of patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension. No intervention.

    Other: No intervention; Observational study

Interventions

  • OtherNo intervention; Observational study

    No intervention; observational study

06

What researchers measure

Primary outcomes

  1. 3-month all cause death

    3-month all cause death

    Time frame: 3 month

Secondary outcomes

  1. dignosis and type of pulmonary hypertension

    dignosis and type of pulmonary hypertension according to latest guidelines

    Time frame: 1 month

  2. 1-year all cause death

    1-year all cause death

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — We retain the property rights to the patient-level data, and therefore will not share this data. We plan to publish the study results and provide aggregate data when necessary.

No publications or documents are linked to this record.

09

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 Jan 2018 (actual). Primary completion is estimated for Dec 2028, 131 months after the start.

Of 64 non-industry observational studies under Pulmonary Arterial Hypertension, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 31. This study's planned 131 months is above that.

Counting every sponsor, half of 85 studies reached it within 58 months; a quarter within 30 and three quarters within 93.

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

Registered
Apr 24, 2025
First posted
May 2, 2025
StartActual
Jan 1, 2018
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2030
Last update
May 21, 2025
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 May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06954727
Responsible party
Zhenguo Zhai,MD,PhD (Professor, China-Japan Friendship Hospital) — Principal investigator
First posted
May 2, 2025
Start date
Jan 1, 2018
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
May 21, 2025

Study contacts

Zhenguo Zhai
Contact
zhaizhenguo2011@126.com
010-8420-6265
Yu Zhang, MD
Contact
zhangyuccmu2013@yeah.net
+8613120211583
Zhenguo Zhai, PhD
principal investigator · China-Japan Friendship Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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