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OpenTrials
Completed

NCT Number: NCT03523910

Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension

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.

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Key information

Conditions

Pulmonary Arterial Hypertension (PAH) Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Magnetic Resonance Imaging (MRI) with exercise

Device

MRI scan with a novel exercise device.

Other names: MRI

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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
May 14, 2018
Registry last updated
May 14, 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.

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