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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04090866
• Other study ID #: 2019-0286
• Secondary ID: A534285SMPH/MEDI
• Status: Terminated
• Start date: November 14, 2019
• Est. completion date: July 21, 2020

Study information

• Verified date: July 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 21, 2020
• Est. primary completion date: July 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Heart Failure
• Hypertension
• Pulmonary Arterial Hypertension
• Right-Sided Heart Failure

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to augment glucose uptake ("substrate flexibility"), defined as change in rate of glucose uptake from rest to exercise	Substrate flexibility is defined as the change in myocardial to blood pool glucose uptake rate from rest to exercise.	6 months
Secondary	Change in substrate flexibility after initiation of pulmonary vasodilator therapy	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.	6 months