Clinical Trials Logo
  1. Home
  2. Pulmonary Arterial Hypertension
  3. NCT04090866
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT04076241 - Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension N/A
Completed NCT05521113 - Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
Recruiting NCT04972656 - Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension N/A
Completed NCT04908397 - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension Phase 1
Active, not recruiting NCT03288025 - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) N/A
Completed NCT01959815 - Novel Screening Strategies for Scleroderma PAH
Recruiting NCT04266197 - Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study Phase 2
Active, not recruiting NCT06092424 - High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA) N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Terminated NCT02060487 - Effects of Oral Sildenafil on Mortality in Adults With PAH Phase 4
Terminated NCT02253394 - The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study Phase 4
Withdrawn NCT02958358 - FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Not yet recruiting NCT01649739 - Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost Phase 4
Withdrawn NCT01723371 - Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children Phase 1/Phase 2
Unknown status NCT01712997 - Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients Phase 3
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01165047 - Nitric Oxide, GeNO Nitrosyl Delivery System Phase 2
Completed NCT00963027 - Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT00963001 - Effect of Food on the Pharmacokinetics of Oral Treprostinil Phase 1