Status:
COMPLETED
A Study for the Identification of Biomarker Signatures for Diagnosis of Pulmonary Hypertension (PH) in Participants at Low or Intermediate Probability of PH Undergoing Cardiac Magnetic Resonance Imaging
Lead Sponsor:
Actelion
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The primary purpose of this study is to estimate the percentage of participants in the population considered clinically as not having pulmonary hypertension (PH) that are positive for PH biomarker (mi...
Eligibility Criteria
Inclusion
- Referred for diagnostic work-up for pulmonary hypertension (PH)
- With low or intermediate (but not high) probability of PH by transthoracic echocardiography (TTE) according to European Society of Cardiology (ESC)/ European Respiratory Society (ERS) Guidelines if at the time of enrollment Right Heart Catheterization (RHC) is not deemed to be clinically indicated
- 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
- Must sign an Informed consent (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Must sign a separate approval in the ICF if he or she agrees to provide an optional (DNA) sample for research. Refusal to give consent for the optional (DNA) research sample does not exclude a participant from participation in the study
Exclusion
- Undergone RHC within 2 years
- Participants requiring renal dialysis
- Participants post-lung or heart transplant
- Severe left ventricular dysfunction: left ventricular ejection fraction less then (\<) 35 percent
- Ongoing Contagious respiratory disease
Key Trial Info
Start Date :
December 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2022
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04480723
Start Date
December 11 2020
End Date
May 18 2022
Last Update
March 30 2025
Active Locations (8)
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1
Universitatsklinikum Bonn
Bonn, Germany, 53105
2
Universitaetsklinikum Giessen
Giessen, Germany, 35392
3
Universitatsklinikum Schleswig Holstein
Lübeck, Germany, 23538
4
Royal United Hospital
Bath, United Kingdom, BA1 3NG