NCT02061787

Brief Summary

cardiopulmonary exercise test evaluate patients with pulmonary hypertension before and after medical or balloon pulmonary angioplasty treatment

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
53mo left

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Sep 2010Sep 2030

Study Start

First participant enrolled

September 1, 2010

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
16.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2030

Last Updated

September 19, 2024

Status Verified

July 1, 2022

Enrollment Period

20 years

First QC Date

February 11, 2014

Last Update Submit

September 9, 2024

Conditions

Keywords

Chronic Thromboembolic Pulmonary HypertensionPulmonary Arterial Hypertensionballoon pulmonary angioplastycardiopulmonary exercise test

Outcome Measures

Primary Outcomes (3)

  • all cause mortality

    all cause mortality

    5 years

  • mean pulmonary arterial pressure after treatment

    the mean pulmonary arterial pressure of patients with chronic thromboembolic pulmonary hypertension after balloon pulmonary angioplasty treatment

    5 years

  • achievement of low risk

    patients with chronic thromboembolic pulmonary hypertension achievement of low risk after balloon pulmonary angioplasty

    5 years

Secondary Outcomes (1)

  • deterioration of WHO function

    5 years

Study Arms (1)

cardiopulmonary exercise testing

patients diagnosed with pulmonary hypertension, including pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension, were evaluated by cardiopulmonary exercise testing before and after medical or balloon pulmonary angioplasty treatment

Device: balloon pulmonary angioplasty

Interventions

patients with chronic thromboembolic pulmonary hypertension who underwent balloon pulmonary angioplasty

cardiopulmonary exercise testing

Eligibility Criteria

Age5 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pulmonary hypertension who may accomplish cardiopulmonary exercise testing.

You may qualify if:

  • pulmonary arterial hypertension;( WHO1)
  • chronic thromboembolic pulmonary hypertension;
  • pulmonary arterial hypertension due to other cause;

You may not qualify if:

  • massive hemoptysis;
  • unable to accomplish cardiopulmonary exercise testing due to neuromuscular disorders;
  • recent recurrent syncope;
  • pulmonary hypertension due to hypoxia;
  • pulmonary hypertension due to left heart diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

center of pulmonary vascular disease, Fuwai hospital

Beijing, 100037, China

RECRUITING

Related Publications (2)

  • Li X, Duan A, Jin Q, Zhang Y, Luo Q, Zhao Q, Yan L, Huang Z, Hu M, Xiong C, Zhao Z, Liu Z. Exercise feature and predictor of prognosis in patients with pulmonary artery stenosis-associated pulmonary hypertension. ESC Heart Fail. 2022 Dec;9(6):4198-4208. doi: 10.1002/ehf2.14154. Epub 2022 Sep 13.

  • Tang Y, Yao L, Liu Z, Ma X, Luo Q, Zhao Z, Huang Z, Tu L, Gao L, Jin Q, Ni X, Xiong C. Effect of calcium channel blockers evaluated by cardiopulmonary exercise testing in idiopathic pulmonary arterial hypertension responding to acute pulmonary vasoreactivity testing. Pulm Pharmacol Ther. 2017 Apr;43:26-31. doi: 10.1016/j.pupt.2017.01.012. Epub 2017 Feb 1.

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Zhihong Liu, MD,PhD

    Fuwai Hospital, National Center for Cardiovascular Diseases

    STUDY DIRECTOR

Central Study Contacts

Zhihong Liu, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 13, 2014

Study Start

September 1, 2010

Primary Completion (Estimated)

September 8, 2030

Study Completion (Estimated)

September 8, 2030

Last Updated

September 19, 2024

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations