CARE PAH
Research type
Research Study
Full title
An International, non-drug interventional, real-world cohort of PAH patients newly initiating PAH therapy with guideline directed assessments of disease severity
IRAS ID
297621
Contact name
John Cannon
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Duration of Study in the UK
5 years, 11 months, 11 days
Research summary
Pulmonary arterial hypertension (PAH) is a serious chronic disorder of the cardiopulmonary circulation, affecting right heart function and potentially leading to right heart failure and death. The available therapies have positive effects on PAH, but the disease will progress in many patients. Thus, PAH remains a serious life-threatening condition, and research continues for better therapies.
This is a prospective, non-drug interventional, International, multicenter study to collect real-world data from participants who newly initiate any PAH therapy(ies). This study is designed to describe PAH patients in terms of their clinical characteristics, therapies used, disease progression, and outcomes (eg, death, hospitalization, risk category for predicted mortality and patient-reported outcomes in real-world clinical practice).
Patients who have newly initiated a PAH therapy and meet the study eligibility criteria will be asked to consent to participate. The therapy treatment decision is independent of the participant’s inclusion in the study. All aspects of treatment and clinical management of participants will be in accordance with local clinical practice. Patient outcome will be observed at clinical visits using assessments recommended in published guidelines, with mandatory assessments highlighted in the study protocol to ensure availability of data to address the study objectives.
The enrolment goal of this study is approximately 3000 PAH participants internationally who newly initiate PAH therapy, either as first-line therapy or in combination with other PAH therapies. The overall duration of the study will be up to six years.
REC name
London - South East Research Ethics Committee
REC reference
21/LO/0731
Date of REC Opinion
9 Nov 2021
REC opinion
Further Information Favourable Opinion