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Could a simple blood test catch lung hypertension early?

NCT ID NCT04193046

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This completed study looked for specific molecules in the blood (called microRNAs) that could help detect pulmonary hypertension (PH) early. Researchers analyzed blood samples from 907 participants who had or were scheduled for a right heart catheterization, the standard diagnostic test. The goal was to see if a blood test could identify PH as accurately as current methods like echocardiograms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test for early detection of pulmonary hypertension, allowing for earlier treatment.
What could go wrong
This is an early-phase study focused on identifying biomarkers, not testing a treatment. The biomarkers may not prove accurate enough for widespread use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

907 people

The number who actually took part.

Started

Dec 2019

Finished

Feb 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ascension St. Vincent's Lung Institute

    Jacksonville, Florida, 32204, United States

  • CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

    Dnipro, 49070, Ukraine

  • CHU de Brest - Hopital de la Cavale Blanche

    Brest, 29200, France

  • CHU de Montpellier - Arnaud de Villeneuve

    Montpellier, 34295, France

  • CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'

    Cherkasy, 18009, Ukraine

  • Europejskie Centrum Zdrowia Otwock Sp z o o

    Otwock, 05 400, Poland

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Hopital Larrey CHU de Toulouse

    Toulouse, 31059, France

  • Hopital de Bicetre

    Le Kremlin-Bicêtre, 94270, France

  • Hosp Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37008, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 8035, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Hosp. Virgen de La Salud

    Toledo, 45004, Spain

  • Hôpital Cardiologique - Chru Lille

    Lille, 59037, France

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • LSU Health Sciences Center New Orleans

    New Orleans, Louisiana, 70112, United States

  • Lungenfachklinik Immenhausen

    Immenhaus, 34376, Germany

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • National Waiting Times Centre Board Golden Jubilee National Hospital

    Glasgow, G81 4DY, United Kingdom

  • Norton Pulmonary Specialists

    Louisville, Kentucky, 40202, United States

  • Pulmonary Associates Of Richmond

    Richmond, Virginia, 23230, United States

  • Pulmonary Health Physicians, PC

    Liverpool, New York, 13088, United States

  • Royal Free Hospital

    London, NW3 2QG, United Kingdom

  • Royal United Hospital

    Bath, BA1 3NG, United Kingdom

  • SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'

    Kyiv, 03038, Ukraine

  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

    Kyiv, 02000, Ukraine

  • Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

    Szczecin, 70-111, Poland

  • Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

    Sheffield, S10 2RX, United Kingdom

  • The Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • Thoraxklinik Heidelberg

    Heidelberg, 69126, Germany

  • Tufts Medical Center

    Boston, Massachusetts, 02111-1552, United States

  • ULB Erasme Ziekenhuis

    Brussels, 1070, Belgium

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-8550, United States

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Universitaetsklinikum Giessen

    Giessen, 35392, Germany

  • Universitatsklinikum Bonn

    Bonn, 53105, Germany

  • Universitatsklinikum Schleswig Holstein

    Lübeck, 23538, Germany

  • University Of Colorado Cardiac And Vascular Center

    Aurora, Colorado, 80045-2548, United States

  • University Of Iowa - Hospitals & Clinics

    Iowa City, Iowa, 52242, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-5990, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie

    Dresden, 01307, Germany

  • Universitätsklinikum Jena Klinik für Innere Medizin I

    Jena, 07747, Germany

  • VUMC Amsterdam

    Amsterdam, 1007 MB, Netherlands

  • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego

    Lublin, 20 718, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.