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Clinical Trials/NCT04090866
NCT04090866
Terminated
Not Applicable

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

University of Wisconsin, Madison1 site in 1 country2 target enrollmentNovember 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Arterial Hypertension
Sponsor
University of Wisconsin, Madison
Enrollment
2
Locations
1
Primary Endpoint
Ability to augment glucose uptake ("substrate flexibility"), defined as change in rate of glucose uptake from rest to exercise
Status
Terminated
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 14, 2019
End Date
July 21, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • Change in substrate flexibility after initiation of pulmonary vasodilator therapy(6 months)

Study Sites (1)

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