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NCT04090866 Clinical Trial

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
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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