Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension

NCT ID: NCT03523910

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-25
• Study Completion Date: 2017-02-13

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.

Detailed Description

The goals of this study are to quantify right ventricular-pulmonary vascular interactions in different types of PAH, to determine the temporal changes in these interactions with PAH progression and to quantify the effects of exercise on right ventricular function. The inclusion of the subpopulation of PAH patients with systemic sclerosis (SSc) was a result of the anticipation that this group has worse arterial stiffening than other groups, and consequently more inefficient right ventricular-pulmonary vascular interactions, which account for their worse prognosis.

Conditions

Pulmonary Arterial Hypertension (PAH)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient

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

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging (MRI) with exercise

Intervention Type: DEVICE

MRI scan with a novel exercise device.

Interventions

Magnetic Resonance Imaging (MRI) with exercise

MRI scan with a novel exercise device.

Intervention Type: DEVICE

Other Intervention Names

MRI

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of pulmonary arterial hypertension or a subtype

2. Referred for right heart catheterization

3. Age between 18 and 80 years

4. New York Heart Association (NYHA) functional class I, II, or III

Exclusion Criteria

1. Recent syncope (within 1 year)

2. Severe skeletal or muscle abnormalities prohibiting exercise

3. Mixed etiology pulmonary arterial hypertension

4. Severe lung disease

1. Test results indicating severe obstruction

2. Total lung capacity < 60%

5. Pregnancy or breastfeeding

6. NYHA class IV patient

7. Contraindications to magnetic resonance imaging

8. Kidney dysfunction as determined by an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73m2

9. Contraindication to gadolinium

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Francois, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

References

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.

Reference Type: DERIVED

PMID: 30577768 (View on PubMed)

Other Identifiers

1R01HL105598-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015-1526

Identifier Type: -

Identifier Source: org_study_id