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

Terminated

• Conditions: Right-Sided Heart Failure; Pulmonary Arterial Hypertension

• Registration Number: NCT04090866
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-16
• Study Start: 2019-11-14
• Status Verified: 2020-07
• Primary Completion: 2020-07-21
• Study Completion: 2020-07-21
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ability to augment glucose uptake ("substrate flexibility"), defined as change in rate of glucose uptake from rest to exercise	6 months	Substrate flexibility is defined as the change in myocardial to blood pool glucose uptake rate from rest to exercise.

Secondary Outcome Measures

Name	Time	Method
Change in substrate flexibility after initiation of pulmonary vasodilator therapy	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.

Trial Locations

Locations (1)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States