NCT02647060

Brief Summary

Pulmonary hypertension (PH) is a progressive disease with high mortality rate, but due to the development of drugs, the prognosis of the disease has improved. However patients still have poor exercise capacity and decrease of the quality of life. Past studies have shown that idiopathic and secondary PH are different in etiology and prognosis. It is necessary to further understand the difference between exercise capacity and quality of life of these two types of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 15, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

January 13, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2016

Completed
Last Updated

July 11, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

December 15, 2015

Last Update Submit

July 10, 2018

Conditions

Keywords

cardiopulmonary exercise testingright ventricle functioncardio outputpulmonary hypertensionquality of life

Outcome Measures

Primary Outcomes (3)

  • exercise capacity

    cardiopulmonary exercise testing(using ''MetaMax 3B system, CORTEX Biophysik GmbH'' as the measure system, and the data will present as VO2)

    within 1 months after inclusion

  • quality of life

    SF-36

    within 1 months after inclusion

  • Functional exercise capacity

    six minutes walk test

    within 1 months after inclusion

Secondary Outcomes (4)

  • Cardiac function

    within 1 months after inclusion

  • Volume of regular physical activity

    within 1 months after inclusion

  • fatigue severity

    within 1 months after inclusion

  • body composition

    within 1 months after inclusion

Study Arms (2)

idiopathic pulmonary hypertension

1. diagnose as idiopathic pulmonary arterial hypertension 2. clinical stable over 3 months 3. able to walk and can do bicycle cardiopulmonary exercise testing

secondary pulmonary hypertension

1. diagnose as pulmonary hypertension 2. clinical stable over 3 months 3. able to walk and can do bicycle cardiopulmonary exercise testing

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pulmonary hypertension, clinical stable, able to walk and can perform cardiopulmonary exercise testing by bicycle

You may qualify if:

  • diagnose as pulmonary hypertension
  • clinical stable over 3 months
  • able to walk and can perform cardiopulmonary exercise testing by bicycle

You may not qualify if:

  • acute right heart failure
  • sever arrythmia
  • the history of exercise induce syncope

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng Dist, 10055, Taiwan

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Chien Meng-Yueh, PhD

    School and Graduate Institute of Physical Therapy, National Taiwan University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2015

First Posted

January 6, 2016

Study Start

January 13, 2016

Primary Completion

April 1, 2016

Study Completion

November 19, 2016

Last Updated

July 11, 2018

Record last verified: 2018-06

Locations