Clinical trial NCT04090866: Cardiac Metabolic Remodeling After Pulmonary Vasodilator Therapy in Pulmonary Arterial Hypertension: A Pilot Study
Official title: Cardiac Metabolic Remodeling After Pulmonary Vasodilator Therapy in Pulmonary Arterial Hypertension: A Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Arterial Hypertension
Right-Sided Heart Failure
Keywords: pulmonary arterial hypertension
right-sided heart failure
metabolism
PET/MRI
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: United Therapeutics
First posted: 2019-09-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with IPAH or CTD-PAH

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.

Eligibility 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

Primary outcomes:
measure: Ability to augment glucose uptake ("substrate flexibility"), defined as change in rate of glucose uptake from rest to exercise
timeFrame: 6 months
Secondary outcomes:
measure: Change in substrate flexibility after initiation of pulmonary vasodilator therapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kara Goss, MD
role: PRINCIPAL_INVESTIGATOR
References: