Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension

Pulmonary Arterial Hypertension (PAH) Clinical Trial

Official title:

Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523910
• Other study ID #: 2015-1526
• Secondary ID: 1R01HL105598-01A
• Status: Completed
• Phase: N/A
• Start date: April 25, 2012
• Est. completion date: February 13, 2017

Study information

• Verified date: May 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 13, 2017
• Est. primary completion date: February 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension (PAH)

Intervention

Device:
• Magnetic Resonance Imaging (MRI) with exercise
MRI scan with a novel exercise device.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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