FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan

Withdrawn before enrolling · Not applicable

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT02958358

Run by

Robert Scott Harris, M.D.

People needed

0

Starts

2014-09-01

Expected to finish

2016-09-01

Last updated by the study team

2016-11-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is male or female aged > or =18 years of age and < or =70 years.
• Subject is diagnosed with pulmonary arterial hypertension (WHO Group I, by right heart catheterization (RHC), mean PA pressure > 25 and PCWP < 15) and planning to start therapy with ambrisentan, either as de-novo monotherapy or as part of combination therapy.
• Subject has most recently undergone RHC within three months of entering the study.
• If patient has been on PAH-specific therapy, the therapy (agent and dose) has been unchanged for at least three months.
• The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• A signed and dated written informed consent is obtained from the subject.
• Available to complete the study.
• Able to fast for 6 hours prior to the study.
• Able to lie flat and able to perform a 30 second breath hold.

You may not qualify if…

• FEV1 and/or TLC < 70% predicted.
• PCWP > 15 mm Hg.
• Inability to perform the study (by primary MD or investigator assessment).
• The subject is unable to perform the respiratory maneuvers necessary for the exam.
• Subjects who have diabetes mellitus or glucose intolerance.
• Subjects who have a known contraindication to ambrisentan.
• Subjects who have a past or present disease, which as judged by the Investigators may affect the outcome of this study.
• The subject has suspected history of drugs or alcohol abuse within the six months prior to the screening visit.
• The subject is a woman of childbearing potential who is pregnant, seeking to become pregnant, or has a positive pregnancy test.
• Subject with clinical instability in the judgment of the investigator, or hospitalization for progression of pulmonary hypertension or right heart failure in the three months prior to the study.
• Subject with diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, asthma, heart failure, ischemic heart disease, or COPD.
• Subject that had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.
• The subject has been exposed to a radiation dose over the past year that, when added to the radiation dose expected in this study, would exceed permissible yearly exposure as determined by the MGH radiation safety committee.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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