EXPERT - Riociguat Registry
Research type
Research Study
Full title
EXPosurE Registry RiociguaT in patients with pulmonary hypertension
IRAS ID
159544
Contact name
Owen Collins
Contact email
Sponsor organisation
Bayer HealthCare
Duration of Study in the UK
3 years, 8 months, 30 days
Research summary
The term Pulmonary Hypertension (PH) refers to high blood pressure in the lungs. PH affects only the blood vessels in the lungs and the right side of the heart.
Pulmonary Arterial Hypertension (PAH) causes the walls of the arteries of the lungs to tighten and stiffen. In someone with PAH, the right side of the heart has to work harder to push blood through narrowed arteries in the lungs. PAH is a chronic and life-changing disease that can lead to right heart failure if left untreated.
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) is a form of pulmonary hypertension caused by old blood clots in the lungs.
PAH and CTEPH are rare and life-threatening diseases. Adempas® has shown to be effective and well tolerated in both indications in two randomized controlled trials. In accordance with the regulatory requirements this registry has been designed to collect information about the long-term safety of Adempas® in real clinical practice outside the regulated environment of a controlled clinical study.
The EXPERT registry is a global, multicenter, prospective, uncontrolled, non-interventional study collecting data from patients with PH treated with Adempas®. Patients will be followed for up to 1 to 4 years.
Patients who have been prescribed Adempas® for a medically appropriate use will be eligible to be included into this registry.
The primary objective is the assessment of long-term safety of Adempas® in real life clinical practice. In addition it is going to prospectively collect data on clinical effectiveness, resource use, and how Adempas® is used by Pulmonary Hypertension (PH) experts under real-life conditions.
It is planned to enroll a total of 900 patients from around the world, with the aim to include a significant proportion of patients newly starting Adempas® treatment.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/1297
Date of REC Opinion
10 Dec 2014
REC opinion
Further Information Favourable Opinion