Ri Hospital Fights Pulmonary Disease with New Trial
Tuesday, May 03, 2011
Rhode Island Hospital is currently recruiting patients for a new clinical trial to test treatments for pulmonary arterial hypertension (PAH). This serious and life-threatening disease is found in the vessels in the lungs. With PAH, the vessels become constricted and blocked, and are therefore unable to expand and deliver an adequate amount of oxygen. Patients with PAH typically die of heart failure within two to five years from the time of diagnosis if untreated.
Is combination therapy early more effective?
A variety of newly developed medicines have been used in the management of PAH, yet treatment response varies. This new study, the Ambition Trial, is designed to determine if combination therapy started at the beginning of treatment is more effective than the current treatment practice of initiating one therapy and then only adding on additional therapies when a patient’s disease worsens.
The treatments being tested in the Ambition Trial are both FDA approved, separately, but have not been used together. Ambrisentan and Tadalafil increase blood flow by dilating blood vessels in the lung, which will fight against the PAH that constricts lung vessels and keeps patients from receiving enough oxygen. The combination of these trial drugs is aimed at slowing the growth of the cells that clog up lung vessels.
A total of 352 patients are being recruited and will be split into two groups, with one receiving both trial drugs and the other receiving just one of the trial drugs. All participants will receive at least 24 weeks of trial therapy. During this time, participants will be measured every four weeks for vital signs, 6-minute walk distances, surveys and lab tests.
To participate, patients must meet several criteria. They must be 18 years of age or older, have been recently diagnosed officially with PAH, and not be currently on any type of specific treatment for PAH, among other parameters outlined by the research team.
This study is being led by James Klinger, M.D., medical director of the Pulmonary Hypertension Center at Rhode Island Hospital, and a member of the University Medicine Foundation. To learn more about this study, or to participate, please contact Barbara Smithson, R.N., at 401-444-9097.
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