Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension

NCT03523910 | Completed DMC

• 2 other identifiers: 2015-15261R01HL105598-01A1
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goals of this study were two-fold. First, the attempt to quantify the relationships between pulmonary arterial stiffness, right ventricular function and the efficiency of ventricular-vascular interactions in patients with pulmonary arterial hypertension (PAH). Second, the attempt to quantify the effects of exercise on pulmonary arterial stiffness, pulmonary vascular resistance, right ventricular function and the efficiency of ventricular-vascular interactions in patients with PAH.

Conditions

Pulmonary Arterial Hypertension (PAH)

Outcome Measures

Primary Outcomes (1)

• The primary outcome is to comprehensively quantify right ventricular and pulmonary vascular function at rest and with exercise using magnetic resonance imaging.

  The hypotheses will be tested by comprehensively quantifying ventricular and vascular function in subjects with idiopathic pulmonary arterial hypertension, systemic sclerosis pulmonary arterial hypertension, and chronic thromboembolic pulmonary hypertension, using investigational magnetic resonance angiography techniques.

  Up to 24 months

Study Arms (1)

Patient

EXPERIMENTAL

A research MRI scan with exercise will be obtained in conjunction with standard of care cardiopulmonary testing.

Device: Magnetic Resonance Imaging (MRI) with exercise

Interventions

Magnetic Resonance Imaging (MRI) with exercise DEVICE

MRI scan with a novel exercise device.

Also known as: MRI

Patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of pulmonary arterial hypertension or a subtype
• Referred for right heart catheterization
• Age between 18 and 80 years
• New York Heart Association (NYHA) functional class I, II, or III

You may not qualify if:

• Recent syncope (within 1 year)
• Severe skeletal or muscle abnormalities prohibiting exercise
• Mixed etiology pulmonary arterial hypertension
• Severe lung disease
• Test results indicating severe obstruction
• Total lung capacity \< 60%
• Pregnancy or breastfeeding
• NYHA class IV patient
• Contraindications to magnetic resonance imaging
• Kidney dysfunction as determined by an estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73m2
• Contraindication to gadolinium

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (1)

• Macdonald JA, Franҫois CJ, Forouzan O, Chesler NC, Wieben O. MRI assessment of aortic flow in patients with pulmonary arterial hypertension in response to exercise. BMC Med Imaging. 2018 Dec 22;18(1):55. doi: 10.1186/s12880-018-0298-9.

  PMID: 30577768 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Christopher Francois, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, open label, single-arm

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: May 14, 2018
• Study Start: April 25, 2012
• Primary Completion: February 13, 2017
• Study Completion: February 13, 2017
• Last Updated: May 14, 2018

Record last verified: 2018-05