NCT04968210Completed
Metabolic Remodeling in Pulmonary Arterial Hypertension (PAH)
Cardiac Metabolic Remodeling After Pulmonary Vasodilator Therapy in Pulmonary Arterial Hypertension: A Pilot Study
Source: ClinicalTrials.gov · Last updated 13 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 3 (actual)
- First submitted
- 7 Jul 2021
- Start date
- 27 May 2022
- Primary completion date
- 17 Dec 2024
- Lead sponsor
- University of Texas Southwestern Medical Center
- NCT number
- NCT04968210
What you commit to
- Study type: Observational
- Participants enrolled: 3
- From 27 May 2022 to the primary completion date, 17 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Baseline use of oral steroids.
- 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.
Other illness
- Baseline 6MWD \< 400 feet or NYHA class IV heart failure.
- Metabolic disorders such as uncontrolled diabetes (A1c \> 8%) that may alter cardiac metabolism.
Other
- Recent syncope.
- FEV1/FVC \<60%
- 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
Who the study is looking for
- 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).
- New York Heart Association (NYHA) classification I - III criteria of heart failure.
- Vasodilator therapy naïve, with the intent to initiate pulmonary vasodilator therapy.
- Age 18 - 75.
- English speaking and able to provide informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.