Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension

Not Applicable

Completed

• Conditions: Pulmonary Arterial Hypertension (PAH)
• Interventions: Device: Magnetic Resonance Imaging (MRI) with exercise

• Registration Number: NCT03523910
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study Start: 2012-04-25
• Primary Completion: 2017-02-13
• Study Completion: 2017-02-13
• Study First Submitted: 2018-02-26
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-01
• Last Update Submitted: 2018-05-01
• Study First Posted: 2018-05-14
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient	Magnetic Resonance Imaging (MRI) with exercise	A research MRI scan with exercise will be obtained in conjunction with standard of care cardiopulmonary testing.

Primary Outcome Measures

Name	Time	Method
The primary outcome is to comprehensively quantify right ventricular and pulmonary vascular function at rest and with exercise using magnetic resonance imaging.	Up to 24 months	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.