A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)

  • STATUS
    Recruiting
  • End date
    May 31, 2022
  • participants needed
    800
  • sponsor
    Janssen Research & Development, LLC
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Updated on 27 March 2021
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right heart catheterization

Summary

The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (TTE) in identifying participants with PH documented by RHC.

Details
Condition Pulmonary Hypertension, Cancer Prevention, Surviving Abuse, Joint Injuries, Abdominal Surgery, Mental Disability, Pelvic Adhesions, Low Testosterone, Dental Filling, Habit Reversal, Complicated Grief, Chronic Pelvic Pain, Gambling Problems, Myopic Macular Degeneration, Nerve Injury, Severe Premenstrual Symptom, Stasis Dermatitis, Pulmonary Arterial Hypertension, Open Heart Surgery, Recurrent Pregnancy Loss, Effects of Chemotherapy, Renal Anemia, Functional Dyspepsia, Catheter Complications, Serial Evaluation of Ductal Epithelium, Chronic Renal Anemia, Cancer Treatment, Anemic Cancer, Spinocerebellar Disorders, Pseudobulbar Affect, Spine Athroplasty, Indikation: Diabetes - Typ II, Partial Medial Meniscectomy, Primary Insulin Hypersecretion, Testotoxikose, Infantile Fibrosarcoma, Late Infantile Neuronal Ceroid Lipfuscinsosis, Memory Problems
Treatment Blood sample, ReCIVA® Breath Sampler and CASPER air supply unit
Clinical Study IdentifierNCT04193046
SponsorJanssen Research & Development, LLC
Last Modified on27 March 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Habit Reversal or Cancer Treatment or Abdominal Surgery or Primary Insulin Hypersecretion or Memory Problems or Pulmonary Arterial Hypertension or Men...?
Do you have any of these conditions: Cancer Treatment or Memory Problems or Pelvic Adhesions or Functional Dyspepsia or Cancer Prevention or Stasis Dermatitis or Primary Insulin Hypersecr...?
Do you have any of these conditions: Testotoxikose or Primary Insulin Hypersecretion or Dental Filling or Serial Evaluation of Ductal Epithelium or Cancer Prevention or Pulmonary Arterial...?
Do you have any of these conditions: Anemic Cancer or Pelvic Adhesions or Effects of Chemotherapy or Late Infantile Neuronal Ceroid Lipfuscinsosis or Serial Evaluation of Ductal Epitheliu...?
Do you have any of these conditions: Chronic Pelvic Pain or Memory Problems or Stasis Dermatitis or Pseudobulbar Affect or Mental Disability or Renal Anemia or Effects of Chemotherapy or ...?
Do you have any of these conditions: Chronic Pelvic Pain or Pulmonary Hypertension or Effects of Chemotherapy or Spine Athroplasty or Late Infantile Neuronal Ceroid Lipfuscinsosis or Seve...?
Do you have any of these conditions: Primary Insulin Hypersecretion or Spine Athroplasty or Testotoxikose or Pseudobulbar Affect or Partial Medial Meniscectomy or Renal Anemia or Recurren...?
Do you have any of these conditions: Late Infantile Neuronal Ceroid Lipfuscinsosis or Chronic Pelvic Pain or Mental Disability or Dental Filling or Functional Dyspepsia or Catheter Compli...?
Do you have any of these conditions: Habit Reversal or Open Heart Surgery or Pseudobulbar Affect or Gambling Problems or Memory Problems or Renal Anemia or Stasis Dermatitis or Pulmonary ...?
Do you have any of these conditions: Chronic Renal Anemia or Low Testosterone or Late Infantile Neuronal Ceroid Lipfuscinsosis or Complicated Grief or Stasis Dermatitis or Renal Anemia or...?
Having undergone an right heart catheterization (RHC) within 18 months (prevalent PH participants) or 6 months (prevalent non-PH participants) or have undergone or planned RHC within 6 weeks (incident participants). The results of the incident RHC (incident participants) or the most recent RHC (prevalent participants) will be used to classify the participant in one of the above study population categories
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 provide an Informed Consent Form (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
Must provide a separate informed consent (or their legally-acceptable representative must sign) if he or she agrees to provide an optional (deoxyribonucleic acid [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

Participants requiring renal dialysis
History of lung or heart transplant (waiting list status or consideration of enlisting is allowed)
Severe left ventricular dysfunction: Left ventricular ejection function less then (<) 35 percent (%)
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