A Prospective, Multicenter Study for the Identification of Biomarker Signatures for early detection of Pulmonary Hypertension (PH) - NAPUH0001 / CIPHER

Janssen-Cilag0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年9月2日

适应症

试验速览

暂无简介。

•1. Male or female.
•2. Age >=18 years of age inclusive.
•3. Having undergone an RHC within 18 months (prevalent PH patients) or 6 months
•(prevalent non-PH patients) or have undergone or planned RHC within 6 weeks
•(incident patients). The results of the incident RHC (incident patients) or the
•most recent RHC (prevalent patients) will be used to classify the participant
•in one of the study population categories.
•4. Medically stable on the basis of physical examination, medical history and
•vital signs performed at screening. Any abnormalities must be consistent with
•the underlying illness in the study population and this determination must be
•recorded in the participant*s source documents and initialed by the
•investigator.
•5. Must sign an ICF (or their legally acceptable representative must sign)
•indicating that he or she understands the purpose of, and procedures required
•for, the study and is willing to participate in the study.
•6. Must provide informed consent (or their legally-acceptable representative
•must sign) if he or she agrees to provide an optional (DNA) sample for research
•(where local regulations permit). Refusal to give consent for the optional
•(DNA) research sample does not exclude a participant from participation in the

•1. Participants requiring renal dialysis.
•2. History of lung or heart transplant (waiting list status or consideration of
•enlisting is allowed).
•3. Severe left ventricular dysfunction: Left ventricular ejection function <35%.
•4. Ongoing contagious respiratory disease.
•5. Participants that have previously contributed blood samples for biomarker
•analysis in the Actelion retrospective study of biomarkers for PH.
•6. Participants unable to have at least 2 tubes of 10 mL blood drawn (i.e., one
•10 mL plasma tube and one 10 mL serum tube).
•7. For incident patients: treatment with any PAH specific drug prior to
•collection of biomarker samples.

发起方