Metabolic Remodeling in Pulmonary Arterial Hypertension (PAH)

RECRUITING

I'm interested ...!!

Pulmonary arterial hypertension (PAH) is a progressive disease in which clinically relevant symptoms present a few years after the onset in rise of pulmonary arterial pressure. Increased PA pressure presents an overload on the right ventricle (RV), with RV failure being a common cause of mortality in PAH. Current therapeutic targets help reduce vascular resistance and RV afterload, however, RV dysfunction may continue to progress. Therefore, the reason for RV failure in PAH cannot be contributed to altered vascular hemodynamics alone but may be related to metabolic alterations and failure of adaptive mechanisms in the RV. Providing a better understanding of metabolic remodeling in RV failure may permit the development of RV-targeted pharmacological agents to maintain RV function despite increased pulmonary vascular pressures. This study will evaluate how cardiac metabolism changes in response to pulmonary vasodilator therapy in patients with pulmonary arterial hypertension.

Conditions:

🦠 Pulmonary Arterial Hypertension

🗓️ Study Start (Actual) 27 May 2022

🗓️ Primary Completion (Estimated) December 2024

✅ Study Completion (Estimated) December 2024

👥 Enrollment (Estimated) 3

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Dallas, Texas, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

1. WHO group 1 PAH, characterized by mean pulmonary artery pressure ≥25 mmHg, PVR \>3 Woods units, and pulmonary capillary wedge pressure or left ventricular end diastolic pressure ≤15 mmHg. Participants must be further classified as idiopathic PAH (IPAH) or connective tissue disease associated PAH (CTD-PAH).
2. New York Heart Association (NYHA) classification I - III criteria of heart failure.
3. Vasodilator therapy naïve, with the intent to initiate pulmonary vasodilator therapy.
4. Age 18 - 75.
5. English speaking and able to provide informed consent.

Exclusion Criteria:

1. Recent syncope.
2. Baseline 6MWD \< 400 feet or NYHA class IV heart failure.
3. Metabolic disorders such as uncontrolled diabetes (A1c \> 8%) that may alter cardiac metabolism.
4. Baseline use of oral steroids.
5. FEV1/FVC \<60%
6. Contraindications to MRI, including those noted on the UTSW MRI Screening Form such as implants contraindicated at 3T, pacemakers, Implantable Cardioverter Defibrillators (ICD), or significant claustrophobia.
7. Weight \>210 lbs (exceeds current IND weight-based dosing guidelines) 8 . Women who are pregnant, lactating or planning on becoming pregnant during the study.
9. Not suitable for study participation due to other reasons at the discretion of the investigators

Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 7 July 2021
First Submitted that Met QC Criteria 7 July 2021
First Posted 20 July 2021

Study Record Updates

Last Update Submitted that Met QC Criteria 6 May 2024
Last Update Posted 7 May 2024
Last Verified May 2024