Skip to main content
OpenTrials
Completed

NCT Number: NCT02485977

Cardiac MRI in Pulmonary Hypertension

The overall goal of this study is to evaluate agreement between cardiac MR parameters and well-established clinical and catheterization parameters of poor prognosis in patients with pulmonary hypertension. The identification of noninvasive cardiac MR techniques to evaluate myocardial disease in patients with pulmonary hypertension would be beneficial to society due to the potential to replace serial invasive cardiac catheterization procedures with a noninvasive imaging test.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Medical Center

San Francisco, California, 94143, United States

About this study

1 BACKGROUND Currently the gold standard for evaluation of pulmonary hypertension is right heart pressure as measured by cardiac catheterization. Thus the method for stratifying patients with pulmonary hypertension in terms of risk and response to treatment is suboptimal, requiring multiple invasive procedures.

A number of studies have suggested that cardiac MR imaging is useful in the diagnosis of myocardial disease and may be related to patient prognosis in both ischemic and non-ischemic cardiomyopathy. Patients with pulmonary hypertension demonstrate post gadolinium delayed enhancement at the points of insertion of the right ventricle onto the inter-ventricular septum, and the presence of this finding has been shown to be inversely correlated with right ventricular function.

Quantitative evaluation of extracellular volume by post-gadolinium T1 relaxation time mapping (T1 mapping) and extracellular volume (ECV) mapping is used to quantify the extent of myocardial fibrosis, can detect fibrosis earlier than delayed enhancement imaging, and is particularly useful in non-ischemic or diffuse myocardial diseases. In addition, Displacement Encoding with Stimulated Echoes (DENSE) is a technique that allows quantification of tissue motion and myocardial strain, which can identify early myocardial dysfunction in patients with preserved ejection fraction, and therefore may be useful in the evaluation of myocardial function in pulmonary hypertension.

Utilization of novel cardiac MR techniques for quantitative assessment of the extent of subclinical myocardial disease in patients with pulmonary hypertension may therefore serve as a non-invasive tool to inform prognosis and surrogate biomarker to evaluate effectiveness of treatment strategies, with the potential to replace serial cardiac catheterization in these patients.

Our hypothesis is that utilization of novel cardiac MR techniques for quantitative assessment of the extent of subclinical myocardial disease in patients with pulmonary hypertension may serve as a non-invasive tool to inform prognosis and surrogate biomarker to evaluate effectiveness of treatment strategies, with the potential to replace serial cardiac catheterization in these patients.

Adult patients with pulmonary hypertension under clinical care at the UCSF pulmonary hypertension clinic who are referred for right heart catheterization will be invited to participate in our study. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Each participant will undergo cardiac MR examination during a single one-hour study visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult
  • Pulmonary hypertension

Exclusion criteria

  • Pacemaker
  • Renal dysfunction
  • Cochlear implant
  • Previous lung transplant

Treatment and study plan

Magnetic Resonance Imaging

Device

MRI study will be performed on 1.5 Tesla magnet, during the administration of Gadolinium

Primary outcomes

  1. MRI scar burden measured by T1 mapping

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2015
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.