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Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension

Primary Purpose

Pulmonary Arterial Hypertension (PAH)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnetic Resonance Imaging (MRI) with exercise
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Arterial Hypertension (PAH)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patient

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 26, 2018
    Last Updated
    May 1, 2018
    Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03523910
    Brief Title
    Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension
    Official Title
    Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 25, 2012 (Actual)
    Primary Completion Date
    February 13, 2017 (Actual)
    Study Completion Date
    February 13, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Arterial Hypertension (PAH)

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single center, open label, single-arm
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patient
    Arm Type
    Experimental
    Arm Description
    A research MRI scan with exercise will be obtained in conjunction with standard of care cardiopulmonary testing.
    Intervention Type
    Device
    Intervention Name(s)
    Magnetic Resonance Imaging (MRI) with exercise
    Other Intervention Name(s)
    MRI
    Intervention Description
    MRI scan with a novel exercise device.
    Primary Outcome Measure Information:
    Title
    The primary outcome is to comprehensively quantify right ventricular and pulmonary vascular function at rest and with exercise using magnetic resonance imaging.
    Description
    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.
    Time Frame
    Up to 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher Francois, MD
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30577768
    Citation
    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.
    Results Reference
    derived

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    Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension

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