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

NCT ID: NCT04090866

Last Updated: 2020-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-14

Study Completion Date

2020-07-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Arterial Hypertension Right-Sided Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United Therapeutics

INDUSTRY

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kara Goss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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A534285

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/MEDICINE*P

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 8/2/2019

Identifier Type: OTHER

Identifier Source: secondary_id

2019-0286

Identifier Type: -

Identifier Source: org_study_id

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