NCT01491646

Brief Summary

Pulmonary hypertension (PH) is a condition in which high blood pressure develops in the lungs and right side of the heart. People with PH suffer from shortness of breath, chest pain, heart failure, heart rhythm problems, and fainting. PH is diagnosed using a test called a cardiac catheterization where blood pressure is measured directly using a tube placed in the right side of the heart and lung arteries. Because a cardiac catheterization is invasive, researchers are investigating ways to diagnose PH using imaging tests that are not invasive. The study will evaluate whether or not a magnetic resonance image (MRI) of the heart, and blood tests can detect PH.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Typical duration 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

November 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

2.9 years

First QC Date

December 12, 2011

Last Update Submit

October 19, 2020

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertensioncardiac magnetic resonance imagingCharacterize and quantify RV vortex flowAssess feasibility of cardiac MR for RVDD diagnosisBiomarker information to help diagnose

Outcome Measures

Primary Outcomes (1)

  • Correlation between RV diastolic function and vorticity

    2 years

Study Arms (2)

Pulmonary Hypertension

Previous diagnosis of PH by right heart catheterization

Healthy Controls

Healthy controls without lung/heart conditions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

specialist clinics community

You may qualify if:

  • previous diagnosis of PH by right heart catheterization
  • RV diastolic dysfunction by echo
  • normal RV systolic function
  • age 18-75 years old
  • no contraindication to MRI

You may not qualify if:

  • absence of PH
  • absence of RV diastolic dysfunction by echo
  • RV systolic dysfunction
  • age \< 18 years
  • contraindication to MRI
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (5)

  • Shiina Y, Funabashi N, Lee K, Daimon M, Sekine T, Kawakubo M, Sekine Y, Takahashi M, Yajima R, Wakatsuki Y, Tanabe N, Kuriyama T, Komuro I. Doppler imaging predicts cardiac events in chronic pulmonary thromboembolism. Int J Cardiol. 2009 Apr 3;133(2):167-72. doi: 10.1016/j.ijcard.2007.12.017. Epub 2008 Feb 1.

    PMID: 18242738BACKGROUND

  • Shiina Y, Funabashi N, Lee K, Daimon M, Sekine T, Kawakubo M, Takahashi M, Yajima R, Tanabe N, Kuriyama T, Komuro I. Right atrium contractility and right ventricular diastolic function assessed by pulsed tissue Doppler imaging can predict brain natriuretic peptide in adults with acquired pulmonary hypertension. Int J Cardiol. 2009 Jun 12;135(1):53-9. doi: 10.1016/j.ijcard.2008.03.090. Epub 2008 Sep 14.

    PMID: 18793807BACKGROUND

  • Pasipoularides AD, Shu M, Womack MS, Shah A, Von Ramm O, Glower DD. RV functional imaging: 3-D echo-derived dynamic geometry and flow field simulations. Am J Physiol Heart Circ Physiol. 2003 Jan;284(1):H56-65. doi: 10.1152/ajpheart.00577.2002. Epub 2002 Sep 12.

    PMID: 12388220BACKGROUND

  • Kheradvar A, Gharib M. On mitral valve dynamics and its connection to early diastolic flow. Ann Biomed Eng. 2009 Jan;37(1):1-13. doi: 10.1007/s10439-008-9588-7. Epub 2008 Nov 4.

    PMID: 18982451BACKGROUND

  • Hong GR, Pedrizzetti G, Tonti G, Li P, Wei Z, Kim JK, Baweja A, Liu S, Chung N, Houle H, Narula J, Vannan MA. Characterization and quantification of vortex flow in the human left ventricle by contrast echocardiography using vector particle image velocimetry. JACC Cardiovasc Imaging. 2008 Nov;1(6):705-17. doi: 10.1016/j.jcmg.2008.06.008. Epub 2008 Nov 18.

    PMID: 19356506BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, serum

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Brett Fenster, MD, FACC, FACP

    National Jewish Health

    PRINCIPAL INVESTIGATOR

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 12, 2011

First Posted

December 14, 2011

Study Start

November 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

US(1)