Pulmonary HypertensionNCT00370214
REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management
An observational study of Pulmonary Hypertension, run by Actelion at 54 sites in United States.
Trial summary
The REVEAL Registry™ is a multicenter, observational, U.S.-based study of the clinical course and disease management of pulmonary arterial hypertension (PAH) patients. All consecutive consenting patients diagnosed with WHO Group I PAH according to specific hemodynamic criteria at participating institutions will be… Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 3,515 participants
- Where
- 54 sitesUnited States
- Study dates
- Mar 2006to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with WHO Group I Pulmonary Arterial Hypertension from US based PAH centers.
Who may be able to join
- Newly diagnosed or previously diagnosed patients with WHO Group I PAH.
- Documentation of the following hemodynamic parameters by right heart catheterization, performed at any time prior to study enrollment:
- Mean pulmonary arterial pressure (mPAP) >25 mm Hg at rest or mPAP > 30 mm Hg with exercise contemporaneous with a pulmonary wedge pressure ≤ 18 mm Hg
- Pulmonary wedge pressure ≤ 18 mm Hg
- Pulmonary vascular resistance (PVR) ≥ 240 dynes.sec.cm-5 (i.e., ≥ 3.0 Wood units)
Who cannot join
- Patients who meet the criteria for inclusion into WHO Groups II, III, IV or V
- Have not had documentation of hemodynamic criteria for PAH by right heart catheterization at some time preceding study entry and following development of symptoms associated with PAH.
- Do not meet the required hemodynamic criteria for entry into the study
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
United States54 sites
Medical College of Georgia
Augusta, Georgia, 30912
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins
Baltimore, Maryland, 21205
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tufts-New England Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston University School of Medicine
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago Hospitals
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44022
University Hospital of Cleveland
Cleveland, Ohio, 44106
Children's Hospital
Columbus, Ohio, 43210
Ohio State University
Columbus, Ohio, 43210
The Children's Hospital
Denver, Colorado, 80218
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Wayne State University
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042
University of Florida
Gainesville, Florida, 32610
Spectrum Health Hospitals
Grand Rapids, Michigan, 49506
Baylor College of Medicine
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
University of Iowa Health Care
Iowa City, Iowa, 52242
Mayo Clinic
Jacksonville, Florida, 32224
University of California, San Diego
La Jolla, California, 92037
UCLA / VA Medical Center
Los Angeles, California, 90073
UCLA Medical Center
Los Angeles, California, 90095
Kentucky Pulmonary Associates
Louisville, Kentucky, 40202
North Shore University Hospital
Manhasset, New York, 11030
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Intermountain Medical Center
Murray, Utah, 84107
Midwest Heart Foundation
Naperville, Illinois, 60566
Vanderbilt Children's Hospital
Nashville, Tennessee, 37212
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Beth Israel Medical Center
New York, New York, 10003
Columbia University
New York, New York, 10032
Penn Presbyterian Medial Center
Philadelphia, Pennsylvania, 19104
Temple Lung Center
Philadelphia, Pennsylvania, 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Legacy Pulmonary Hypertension Clinic
Portland, Oregon, 97210
Rhode Island Hospital
Providence, Rhode Island, 02903
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55095
University of Rochester Medical Center
Rochester, New York, 14642
University Texas Health Science Center
San Antonio, Texas, 78229
Univeristy of California, San Francisco - Division of Cardiology and Pediatric ICU
San Francisco, California, 94143
Suncoast Lung Center
Sarasota, Florida, 34233
Seattle Children's
Seattle, Washington, 98105
Washington University School of Medicine
St Louis, Missouri, 63021
Stanford University Medical Center
Stanford, California, 94305
UCLA School of Medicine: Harbor-UCLA
Torrance, California, 90502
University of Arizona Medical Center
Tucson, Arizona, 85724
About this study
The REVEAL Registry™ is a multicenter, observational, U.S.-based study of the clinical course and disease management of pulmonary arterial hypertension (PAH) patients. All consecutive consenting patients diagnosed with WHO Group I PAH according to specific hemodynamic criteria at participating institutions will be enrolled. Participating patients will be followed for a minimum of five years from the time of enrollment.
Read the detailed description
Pulmonary arterial hypertension (PAH) is a chronic, progressive, and often fatal disease characterized by severe constriction of the blood vessels in the lungs. Over the past decade, significant strides have been made in the medical management and understanding of PAH. However, much remains to be learned about the clinical course of both idiopathic PAH and associated PAH, including clinical presentation, pace of progression, key parameters to monitor, impact of treatment, and prognosticators of outcome. As the unique body of knowledge generated by the REVEAL Registry grows, it is hoped that new understandings, insights, and treatments will emerge that will improve the lives of patients with PAH.
The REVEAL Registry will provide investigators with descriptive data regarding the clinical course and treatment outcomes in patients with WHO Group I PAH. Data derived from the study may offer important tools for assessing current management practices of treating investigators, as well as changes over time. Additionally, the relationship of patient- and disease-specific parameters to patient outcomes may be able to be assessed through analysis of data from this study.
The specific objectives of the REVEAL Registry™ are to:
- Characterize the demographics and clinical course of PAH patients
- Evaluate and compare patient outcomes
- Identify clinical predictors of short-term and long-term clinical outcomes
- Assess the relationship between PAH medications and patient outcomes
- Report temporal trends in treatments and outcomes for newly diagnosed patients
- Collect timely and relevant data for the evolving research needs of the PAH community
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary arterial hypertension, Lung diseases, Heart diseases, Pulmonary circulation, Vascular resistance, PAH, Hypertension
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Lung Diseases, Heart Diseases, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 5 years
Secondary outcomes (1)
clinical predictors, precise outcome definitions
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael D. McGoon, M.D., Study chair, Mayo Clinic - Rochester, MinnesotaDavid B. Badesch, M.D., Study director, University of Colorado, DenverRobyn J. Barst, M.D., Study director, Columbia UniversityRaymond Benza, M.D., Study director, University of Alabama at BirminghamGregory Elliott, M.D., Study director, LDS HospitalHarrison Farber, M.D., Study director, Boston Medical CenterAdaani Frost, M.D., Study director, Baylor College of MedicineAbby Krichman, RRT, Study director, Duke University Pulmonary Vascular Disease Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370214
- Sponsor's protocol ID
- CR001
- Status last verified
- May 2013
- First submitted
- 29 Aug 2006
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Benza RL, Kanwar MK, Raina A, Scott JV, Zhao CL, Selej M, Elliott CG, Farber HW. Development and Validation of an Abridged Version of the REVEAL 2.0 Risk Score Calculator, REVEAL Lite 2, for Use in Patients With Pulmonary Arterial Hypertension. Chest. 2021 Jan;159(1):337-346. doi: 10.1016/j.chest.2020.08.2069. Epub 2020 Sep 1.
PubMed 32882243Torbicki A, Bacchi M, Delcroix M, Farber HW, Ghofrani HA, Hennessy B, Jansa P, Mehta S, Perchenet L, Pulido T, Rosenberg D, Rubin LJ, Sastry BKS, Simonneau G, Sitbon O, Souza R, Wei LJ, Channick R, Benza R. Integrating Data From Randomized Controlled Trials and Observational Studies to Assess Survival in Rare Diseases. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005095. doi: 10.1161/CIRCOUTCOMES.118.005095.
PubMed 31109190Benza RL, Gomberg-Maitland M, Elliott CG, Farber HW, Foreman AJ, Frost AE, McGoon MD, Pasta DJ, Selej M, Burger CD, Frantz RP. Predicting Survival in Patients With Pulmonary Arterial Hypertension: The REVEAL Risk Score Calculator 2.0 and Comparison With ESC/ERS-Based Risk Assessment Strategies. Chest. 2019 Aug;156(2):323-337. doi: 10.1016/j.chest.2019.02.004. Epub 2019 Feb 14.
PubMed 30772387Preston IR, Roberts KE, Miller DP, Sen GP, Selej M, Benton WW, Hill NS, Farber HW. Effect of Warfarin Treatment on Survival of Patients With Pulmonary Arterial Hypertension (PAH) in the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL). Circulation. 2015 Dec 22;132(25):2403-11. doi: 10.1161/CIRCULATIONAHA.115.018435. Epub 2015 Oct 28.
PubMed 26510696Farber HW, Miller DP, Poms AD, Badesch DB, Frost AE, Muros-Le Rouzic E, Romero AJ, Benton WW, Elliott CG, McGoon MD, Benza RL. Five-Year outcomes of patients enrolled in the REVEAL Registry. Chest. 2015 Oct;148(4):1043-54. doi: 10.1378/chest.15-0300.
PubMed 26066077Chung L, Farber HW, Benza R, Miller DP, Parsons L, Hassoun PM, McGoon M, Nicolls MR, Zamanian RT. Unique predictors of mortality in patients with pulmonary arterial hypertension associated with systemic sclerosis in the REVEAL registry. Chest. 2014 Dec;146(6):1494-1504. doi: 10.1378/chest.13-3014.
PubMed 24992469Burger CD, Long PK, Shah MR, McGoon MD, Miller DP, Romero AJ, Benton WW, Safford RE. Characterization of first-time hospitalizations in patients with newly diagnosed pulmonary arterial hypertension in the REVEAL registry. Chest. 2014 Nov;146(5):1263-1273. doi: 10.1378/chest.14-0193.
PubMed 24901386Frost AE, Badesch DB, Miller DP, Benza RL, Meltzer LA, McGoon MD. Evaluation of the predictive value of a clinical worsening definition using 2-year outcomes in patients with pulmonary arterial hypertension: a REVEAL Registry analysis. Chest. 2013 Nov;144(5):1521-1529. doi: 10.1378/chest.12-3023.
PubMed 23907471Bersohn MM, Turner MP, Traiger GL, Frost AE, Shapiro S. Systemic BP and heart rate as prognostic indicators in pulmonary arterial hypertension. Chest. 2013 Sep;144(3):959-965. doi: 10.1378/chest.12-2572.
PubMed 23598723Barst RJ, Chung L, Zamanian RT, Turner M, McGoon MD. Functional class improvement and 3-year survival outcomes in patients with pulmonary arterial hypertension in the REVEAL Registry. Chest. 2013 Jul;144(1):160-168. doi: 10.1378/chest.12-2417.
PubMed 23429998Poms AD, Turner M, Farber HW, Meltzer LA, McGoon MD. Comorbid conditions and outcomes in patients with pulmonary arterial hypertension: a REVEAL registry analysis. Chest. 2013 Jul;144(1):169-176. doi: 10.1378/chest.11-3241.
PubMed 23348820Kitterman N, Poms A, Miller DP, Lombardi S, Farber HW, Barst RJ. Bloodstream infections in patients with pulmonary arterial hypertension treated with intravenous prostanoids: insights from the REVEAL REGISTRY(R). Mayo Clin Proc. 2012 Sep;87(9):825-34. doi: 10.1016/j.mayocp.2012.05.014. Epub 2012 Aug 9.
PubMed 22883740Frost AE, Farber HW, Barst RJ, Miller DP, Elliott CG, McGoon MD. Demographics and outcomes of patients diagnosed with pulmonary hypertension with pulmonary capillary wedge pressures 16 to 18 mm Hg: insights from the REVEAL Registry. Chest. 2013 Jan;143(1):185-195. doi: 10.1378/chest.11-1387.
PubMed 22661451Benza RL, Miller DP, Barst RJ, Badesch DB, Frost AE, McGoon MD. An evaluation of long-term survival from time of diagnosis in pulmonary arterial hypertension from the REVEAL Registry. Chest. 2012 Aug;142(2):448-456. doi: 10.1378/chest.11-1460.
PubMed 22281797Barst RJ, McGoon MD, Elliott CG, Foreman AJ, Miller DP, Ivy DD. Survival in childhood pulmonary arterial hypertension: insights from the registry to evaluate early and long-term pulmonary arterial hypertension disease management. Circulation. 2012 Jan 3;125(1):113-22. doi: 10.1161/CIRCULATIONAHA.111.026591. Epub 2011 Nov 15.
PubMed 22086881
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management
- ClinicalTrials.gov ID
- NCT00370214
- Acronym / sponsor ID
- CR001
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary arterial hypertension, Lung diseases, Heart diseases, Pulmonary circulation, Vascular resistance, PAH, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,515 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The REVEAL Registry™ is a multicenter, observational, U.S.-based study of the clinical course and disease management of pulmonary arterial hypertension (PAH) patients. All consecutive consenting patients diagnosed with WHO Group I PAH according to specific hemodynamic criteria at participating institutions will be enrolled. Participating patients will be followed for a minimum of five years from the time of enrollment.
Detailed description
Pulmonary arterial hypertension (PAH) is a chronic, progressive, and often fatal disease characterized by severe constriction of the blood vessels in the lungs. Over the past decade, significant strides have been made in the medical management and understanding of PAH. However, much remains to be learned about the clinical course of both idiopathic PAH and associated PAH, including clinical presentation, pace of progression, key parameters to monitor, impact of treatment, and prognosticators of outcome. As the unique body of knowledge generated by the REVEAL Registry grows, it is hoped that new understandings, insights, and treatments will emerge that will improve the lives of patients with PAH.
The REVEAL Registry will provide investigators with descriptive data regarding the clinical course and treatment outcomes in patients with WHO Group I PAH. Data derived from the study may offer important tools for assessing current management practices of treating investigators, as well as changes over time. Additionally, the relationship of patient- and disease-specific parameters to patient outcomes may be able to be assessed through analysis of data from this study.
The specific objectives of the REVEAL Registry™ are to:
- Characterize the demographics and clinical course of PAH patients
- Evaluate and compare patient outcomes
- Identify clinical predictors of short-term and long-term clinical outcomes
- Assess the relationship between PAH medications and patient outcomes
- Report temporal trends in treatments and outcomes for newly diagnosed patients
- Collect timely and relevant data for the evolving research needs of the PAH community
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with WHO Group I Pulmonary Arterial Hypertension from US based PAH centers.
Key inclusion criteria (5 listed)
- Newly diagnosed or previously diagnosed patients with WHO Group I PAH.
- Documentation of the following hemodynamic parameters by right heart catheterization, performed at any time prior to study enrollment:
- Mean pulmonary arterial pressure (mPAP) >25 mm Hg at rest or mPAP > 30 mm Hg with exercise contemporaneous with a pulmonary wedge pressure ≤ 18 mm Hg
- Pulmonary wedge pressure ≤ 18 mm Hg
- Pulmonary vascular resistance (PVR) ≥ 240 dynes.sec.cm-5 (i.e., ≥ 3.0 Wood units)
Key exclusion criteria (3 listed)
- Patients who meet the criteria for inclusion into WHO Groups II, III, IV or V
- Have not had documentation of hemodynamic criteria for PAH by right heart catheterization at some time preceding study entry and following development of symptoms associated with PAH.
- Do not meet the required hemodynamic criteria for entry into the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: 5 years
1 secondary outcome
clinical predictors, precise outcome definitions
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
- Derived from this study: PubMed 32882243Benza RL, Kanwar MK, Raina A, Scott JV, Zhao CL, Selej M, Elliott CG, Farber HW. Development and Validation of an Abridged Version of the REVEAL 2.0 Risk Score Calculator, REVEAL Lite 2, for Use in Patients With Pulmonary Arterial Hypertension. Chest. 2021 Jan;159(1):337-346. doi: 10.1016/j.chest.2020.08.2069. Epub 2020 Sep 1.
- Derived from this study: PubMed 31109190Torbicki A, Bacchi M, Delcroix M, Farber HW, Ghofrani HA, Hennessy B, Jansa P, Mehta S, Perchenet L, Pulido T, Rosenberg D, Rubin LJ, Sastry BKS, Simonneau G, Sitbon O, Souza R, Wei LJ, Channick R, Benza R. Integrating Data From Randomized Controlled Trials and Observational Studies to Assess Survival in Rare Diseases. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005095. doi: 10.1161/CIRCOUTCOMES.118.005095.
- Derived from this study: PubMed 30772387Benza RL, Gomberg-Maitland M, Elliott CG, Farber HW, Foreman AJ, Frost AE, McGoon MD, Pasta DJ, Selej M, Burger CD, Frantz RP. Predicting Survival in Patients With Pulmonary Arterial Hypertension: The REVEAL Risk Score Calculator 2.0 and Comparison With ESC/ERS-Based Risk Assessment Strategies. Chest. 2019 Aug;156(2):323-337. doi: 10.1016/j.chest.2019.02.004. Epub 2019 Feb 14.
- Derived from this study: PubMed 26510696Preston IR, Roberts KE, Miller DP, Sen GP, Selej M, Benton WW, Hill NS, Farber HW. Effect of Warfarin Treatment on Survival of Patients With Pulmonary Arterial Hypertension (PAH) in the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL). Circulation. 2015 Dec 22;132(25):2403-11. doi: 10.1161/CIRCULATIONAHA.115.018435. Epub 2015 Oct 28.
- Derived from this study: PubMed 26066077Farber HW, Miller DP, Poms AD, Badesch DB, Frost AE, Muros-Le Rouzic E, Romero AJ, Benton WW, Elliott CG, McGoon MD, Benza RL. Five-Year outcomes of patients enrolled in the REVEAL Registry. Chest. 2015 Oct;148(4):1043-54. doi: 10.1378/chest.15-0300.
- Derived from this study: PubMed 24992469Chung L, Farber HW, Benza R, Miller DP, Parsons L, Hassoun PM, McGoon M, Nicolls MR, Zamanian RT. Unique predictors of mortality in patients with pulmonary arterial hypertension associated with systemic sclerosis in the REVEAL registry. Chest. 2014 Dec;146(6):1494-1504. doi: 10.1378/chest.13-3014.
- Derived from this study: PubMed 24901386Burger CD, Long PK, Shah MR, McGoon MD, Miller DP, Romero AJ, Benton WW, Safford RE. Characterization of first-time hospitalizations in patients with newly diagnosed pulmonary arterial hypertension in the REVEAL registry. Chest. 2014 Nov;146(5):1263-1273. doi: 10.1378/chest.14-0193.
- Derived from this study: PubMed 23907471Frost AE, Badesch DB, Miller DP, Benza RL, Meltzer LA, McGoon MD. Evaluation of the predictive value of a clinical worsening definition using 2-year outcomes in patients with pulmonary arterial hypertension: a REVEAL Registry analysis. Chest. 2013 Nov;144(5):1521-1529. doi: 10.1378/chest.12-3023.
- Derived from this study: PubMed 23598723Bersohn MM, Turner MP, Traiger GL, Frost AE, Shapiro S. Systemic BP and heart rate as prognostic indicators in pulmonary arterial hypertension. Chest. 2013 Sep;144(3):959-965. doi: 10.1378/chest.12-2572.
- Derived from this study: PubMed 23429998Barst RJ, Chung L, Zamanian RT, Turner M, McGoon MD. Functional class improvement and 3-year survival outcomes in patients with pulmonary arterial hypertension in the REVEAL Registry. Chest. 2013 Jul;144(1):160-168. doi: 10.1378/chest.12-2417.
- Derived from this study: PubMed 23348820Poms AD, Turner M, Farber HW, Meltzer LA, McGoon MD. Comorbid conditions and outcomes in patients with pulmonary arterial hypertension: a REVEAL registry analysis. Chest. 2013 Jul;144(1):169-176. doi: 10.1378/chest.11-3241.
- Derived from this study: PubMed 22883740Kitterman N, Poms A, Miller DP, Lombardi S, Farber HW, Barst RJ. Bloodstream infections in patients with pulmonary arterial hypertension treated with intravenous prostanoids: insights from the REVEAL REGISTRY(R). Mayo Clin Proc. 2012 Sep;87(9):825-34. doi: 10.1016/j.mayocp.2012.05.014. Epub 2012 Aug 9.
- Official REVEAL Registry websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D. McGoon, M.D. study chair
Mayo Clinic - Rochester, Minnesota
David B. Badesch, M.D. study director
University of Colorado, Denver
Robyn J. Barst, M.D. study director
Columbia University
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Actelion at 54 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00370214, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.