NCT02790918

Brief Summary

In this study, study team aim to i) evaluate the accuracy of 3D IVS curvedness for prediction of RV systolic pressure (RVSP), mean pulmonary artery pressure (mPAP) and pulmonary vascular resistance (PVR) with RHC; ii) evaluate the usefulness of 3D IVS curvedness for predicting the response to vasodilator challenge with RHC, in patients clinically suspected or known to have primary PH.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2013

Longer than P75 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

Study Start

First participant enrolled

May 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

6.4 years

First QC Date

May 30, 2016

Last Update Submit

August 2, 2020

Conditions

Keywords

Pulmonary HypertensionMRI

Outcome Measures

Primary Outcomes (1)

  • First occurrence of cardiovascular event.

    1-Year

Study Arms (2)

Diagnosed Pulmonary Hypertension

Patients will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imaging (CMRI) and 6MWT.

Other: 6MWTOther: Cardiovascular Magnetic Resonance Imaging (CMRI)

Healthy Volunteer

Healthy Volunteer will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imaging (CMRI) and 6MWT.

Other: 6MWTOther: Cardiovascular Magnetic Resonance Imaging (CMRI)

Interventions

6MWTOTHER

Each patient will also receive 6MWT at cardiovascular rehabilitation and preventive cardiology laboratory. Besides the distance covered in meters or converted measure (such as feet) over 6 minutes, a portable metabolic system is used to measure oxygen uptake during exercise (VO2 testing) for each patient.

Diagnosed Pulmonary HypertensionHealthy Volunteer

MRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create images; for about 1 hour. Several sets of images are needed. No injection of drug or dye will be used for this procedure.

Diagnosed Pulmonary HypertensionHealthy Volunteer

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 diagnosed pulmonary hypertension patient will be recruited from primary care clinic and outpatient clinics from the National Heart Centre Singapore. 30 Healthy volunteer control.

You may qualify if:

  • Signed informed consent prior to initiation of any study mandated procedure
  • Age 16 years or more.
  • Patient with clinically suspected or known primary PH belonging to one of the Updated Dana Point Clinical Classification Groups (I-IV)
  • No known history of pulmonary hypertension

You may not qualify if:

  • Contraindication to MR examination:
  • Cardiac pacemaker
  • Brain aneurysm or clips
  • Electronic implants or prosthesis
  • Eye metal foreign body injury
  • Severe claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Related Publications (1)

  • Leng S, Dong Y, Wu Y, Zhao X, Ruan W, Zhang G, Allen JC, Koh AS, Tan RS, Yip JW, Tan JL, Chen Y, Zhong L. Impaired Cardiovascular Magnetic Resonance-Derived Rapid Semiautomated Right Atrial Longitudinal Strain Is Associated With Decompensated Hemodynamics in Pulmonary Arterial Hypertension. Circ Cardiovasc Imaging. 2019 May;12(5):e008582. doi: 10.1161/CIRCIMAGING.118.008582.

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Liang Zhong, PhD

    National Heart Centre Singapore

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 6, 2016

Study Start

May 1, 2013

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

August 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations