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

Completed

• Conditions: High blood pressure in lung vessels; Pulmonary hypertension; 10037454

• Registration Number: NL-OMON55313
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-12-14
• Results First Posted: 2022-12-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

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
study.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Identification of potential miRNA biomarker signatures would help in the early<br /><br>diagnosis of PAH. Patients at risk for PAH and CTEPH are especially likely to<br /><br>benefit from earlier diagnosis, as these patients often experience symptoms for<br /><br>years before a diagnosis is made.<br /><br><br /><br>Outcome: biomarker sample collection on Day 1<br /><br>Time schedule of protocol, including follow-up duration: Screening period (max<br /><br>60 days), Assessments on 1 day, additional assessment visit (if needed) up to<br /><br>60 days after day 1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NAP</p><br>