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Cardiac Metabolic Remodeling After Pulmonary Vasodilator Therapy in Pulmonary Arterial Hypertension: A Pilot Study

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ClinicalTrials.gov Identifier: NCT04090866
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
United Therapeutics
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
Pulmonary arterial hypertension(PAH) is associated with the development of right heart failure. In the setting of heart failure, the heart shifts to increasing dependence on glucose metabolism. In this study, the investigators will perform cardiac positron emission tomography/magnetic resonance imaging (PET/MRI) scans to measure glucose metabolism in the heart before and after initiation of pulmonary vasodilator therapy for pulmonary arterial hypertension.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Right-Sided Heart Failure Other: PET/MRI

Detailed Description:
Pulmonary arterial hypertension is associated with the development of right heart failure. In the setting of heart failure, the heart shifts to increasing dependence on glucose metabolism. In this study, the investigators will perform cardiac positron emission tomography/magnetic resonance imaging (PET/MRI) scans to measure glucose metabolism in the heart before and after initiation of pulmonary vasodilator therapy for pulmonary arterial hypertension. By utilizing a rest-exercise protocol and continuous PET imaging acquisition, we can capture real-time changes in glucose uptake in the heart in response to acute exercise. By coupling these measures of dynamic glucose utilization with MRI-based cardiac function, we will determine cardiac metabolic efficiency.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Cardiac Metabolic Remodeling After Pulmonary Vasodilator Therapy in Pulmonary Arterial Hypertension: A Pilot Study
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022



Intervention Details:
  • Other: PET/MRI
    Positron Emission Tomograph/Magnetic Resonance Imaging - participants will undergo PET/MRI prior to initiation of pulmonary vasodilator therapy and again 4-6 months after initiation of therapy


Primary Outcome Measures :
  1. Ability to augment glucose uptake ("substrate flexibility"), defined as change in rate of glucose uptake from rest to exercise [ Time Frame: 6 months ]
    Substrate flexibility is defined as the change in myocardial to blood pool glucose uptake rate from rest to exercise.


Secondary Outcome Measures :
  1. Change in substrate flexibility after initiation of pulmonary vasodilator therapy [ Time Frame: 6 months ]
    Substrate flexibility is defined as the change in myocardial to blood pool glucose uptake rate from rest to exercise. Substrate flexibility before and after pulmonary vasodilator therapy will be compared.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with IPAH or CTD-PAH
Criteria

Inclusion Criteria:

  • World Health Organization(WHO) group PAH secondary into idiopathic pulmonary arterial hypertension(IPAH) or connective tissue disease associated pulmonary arterial hypertension (CTDPAH)
  • New York Heart Association (NYHA) classification I - III heart failure
  • Vasodilator therapy naive
  • Able to provide informed consent

Exclusion Criteria:

  • Metabolic disorders such as uncontrolled diabetes (A1c > 8%) that may interfere with FDG uptake
  • Baseline 6-minute walk distance (6MWD) < 400 feet or NYHA class IV heart failure
  • Musculoskeletal abnormalities that would prevent exercise
  • Contraindications to MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090866


Contacts
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Contact: Kara Goss, MD 608-263-0661 kngoss@medicine.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Jennifer Bagley    608-262-7344    jlbagley@medicine.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
United Therapeutics
Investigators
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Principal Investigator: Kara Goss, MD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04090866     History of Changes
Other Study ID Numbers: 2019-0286
A534285 ( Other Identifier: UW Madison )
SMPH/MEDICINE/MEDICINE*P ( Other Identifier: UW Madison )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
pulmonary arterial hypertension
right-sided heart failure
metabolism
PET/MRI
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Heart Failure
Dextrocardia
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Situs Inversus
Vasodilator Agents