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

NCT04090866 | Terminated

• 4 other identifiers: 2019-0286A534285SMPH/MEDICINE/MEDICINE*PProtocol Version 8/2/2019
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension; Right-Sided Heart Failure

Keywords

pulmonary arterial hypertension; right-sided heart failure; metabolism; PET/MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in substrate flexibility after initiation of pulmonary vasodilator therapy

  6 months

Interventions

PET/MRI OTHER

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with IPAH or CTD-PAH

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• United Therapeutics: collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Heart Failure

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Kara Goss, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: November 14, 2019
• Primary Completion: July 21, 2020
• Study Completion: July 21, 2020
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)