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
Updated on 27 March 2021
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 (%)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note