NCT02164526

Brief Summary

Left heart disease is the main cause of pulmonary hypertension. With the advent of the aging society, chronic heart failure has become a global public health problem. Therefore the prevalence of pulmonary hypertension due to the left heart disease is increasing. However, there is no research on the prevalence of pulmonary hypertension due to the left heart disease in China. Therefore, the aim of the present study was to describe real-world outcome of Chinese patients with pulmonary hypertension due to the left heart disease and identify factors that may predict outcome. Our study will profile the demographics, clinical course, treatments, and outcomes of pulmonary hypertension due to the left heart disease in China.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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 Start

First participant enrolled

January 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

4.9 years

First QC Date

June 4, 2014

Last Update Submit

June 13, 2017

Conditions

Keywords

Pulmonary HypertensionLeft Heart DiseaseHeart failureRegistryChina

Outcome Measures

Primary Outcomes (1)

  • All cause death

    up to 5 years

Study Arms (1)

No treatment

Other: Routine therapy

Interventions

Routine therapy

No treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients who were diagnosed as pulmonary hypertension due to the left heart disease in 35 participating institutions in China

You may qualify if:

  • Pulmonary Hypertension due to left heart disease

You may not qualify if:

  • Other forms of Pulmonary Hypertension
  • Heart failure due to valvular heart disease
  • Hypertrophic obstructive cardiomyopathy
  • Right ventricular outflow tract stenosis
  • Pericardial disease
  • Patients with chronic lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College and Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

RECRUITING

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College and Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (3)

  • Huang L, Pang L, Gu Q, Yang T, Li W, Quan R, Su W, Wu W, Tang F, Zhu X, Shen J, Sun J, Shan G, Xiong C, Huang S, He J. Prevalence, risk factors, and survival associated with pulmonary hypertension and heart failure among patients with underlying coronary artery disease: a national prospective, multicenter registry study in China. Chin Med J (Engl). 2022 Aug 5;135(15):1837-1845. doi: 10.1097/CM9.0000000000002112.

  • Lin Y, Pang L, Huang S, Shen J, Wu W, Tang F, Su W, Zhu X, Sun J, Quan R, Yang T, Han H, He J. Impact of borderline pulmonary hypertension due to left heart failure on mortality in a multicenter registry study: A 3-year survivorship analysis. Front Cardiovasc Med. 2022 Aug 12;9:983803. doi: 10.3389/fcvm.2022.983803. eCollection 2022.

  • Quan R, Huang S, Pang L, Shen J, Wu W, Tang F, Zhu X, Su W, Sun J, Yu Z, Wang L, Zhu X, Xiong C, He J. Risk prediction in pulmonary hypertension due to chronic heart failure: incremental prognostic value of pulmonary hemodynamics. BMC Cardiovasc Disord. 2022 Feb 16;22(1):56. doi: 10.1186/s12872-022-02492-1.

MeSH Terms

Conditions

Hypertension, PulmonaryHeart Failure

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesHeart Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Pulmonary vascular disease center

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 16, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations