Clinical Trials Logo

Clinical Trial Summary

The investigators are doing this research study to find out how blood flow changes in the lungs of people with pulmonary hypertension before and after treatment with ambrisentan (sold under the brand name Letairis). The investigators hope that knowing about these differences will help us to better understand pulmonary hypertension and find new ways to diagnose it earlier.


Clinical Trial Description

The overall goal of this study is to evaluate lung, large vessel, and right ventricular glucose uptake rate using 18FDG PET and distribution of pulmonary perfusion using 13NN PET in patients with pulmonary hypertension before and after treatment with ambrisentan. The investigators propose a pilot study of patients with Group I PAH. The investigators plan to complete this pilot study with 5 patients (projected enrollment of 8 to allow for drop-out rate). Taken together, the studies above demonstrate that FDG-PET can be used to detect changes associated with PAH, and to monitor response to therapy. FDG-PET is a widely available technology, and is firmly established in the field of clinical oncology. Ambrisentan is an endothelin receptor antagonist that is FDA-approved to treat patients with pulmonary arterial hypertension. Patients will be eligible for participation in this study if they have already made a decision to start treatment with ambrisentan for pulmonary hypertension. The investigators propose a physiologic study of patients who will already have made a decision to start ambrisentan therapy. Participation in the study will not alter or affect participants decisions regarding treatment.

Prior human studies evaluating response to PH-specific therapies focused only on the right ventricle. Oikawa et al. looked at the RV uptake in patients with PH and evaluated them before and after treatment with epoprostenol. Fang and colleagues used FDG-SPECT evaluate FDG uptake in the RV of patients with IPAH and PH before and after treatment with sildenafil. Both of those studies used SUV (specific uptake variable). The investigators propose to focus on the lung and the RV uptake rate (Ki) in order to provide a more robust analysis of the metabolic changes that underlie the development of pulmonary hypertension both in the right ventricle and the lung parenchyma, and to study the response to ambrisentan with FDG-PET. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT02958358
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Withdrawn
Phase N/A
Start date September 2014
Completion date September 2016

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
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 NCT00942708 - Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension Phase 2
Completed NCT00963027 - Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT00902174 - Imatinib (QTI571) in Pulmonary Arterial Hypertension Phase 3