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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04090866
Enrollment
2
Registered
2019-09-16
Start date
2019-11-14
Completion date
2020-07-21
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension, Right-Sided Heart Failure

Keywords

pulmonary arterial hypertension, right-sided heart failure, metabolism, PET/MRI

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.

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.

Interventions

OTHERPET/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

Sponsors

United Therapeutics
CollaboratorINDUSTRY
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ability to augment glucose uptake (substrate flexibility), defined as change in rate of glucose uptake from rest to exercise6 monthsSubstrate flexibility is defined as the change in myocardial to blood pool glucose uptake rate from rest to exercise.

Secondary

MeasureTime frameDescription
Change in substrate flexibility after initiation of pulmonary vasodilator therapy6 monthsSubstrate 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026