Systemic SclerosisDETECTNCT00706082
Early, Simple and Reliable Detection of Pulmonary Arterial Hypertension (PAH) in Systemic Sclerosis (SSc)
An observational study of Systemic Sclerosis and Pulmonary Arterial Hypertension, run by Actelion at 83 sites in 20 countries.
Trial summary
A two-stage prospective observational cohort study in scleroderma patients to evaluate screening tests and the incidence of pulmonary arterial hypertension and pulmonary hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Pulmonary Arterial Hypertension, Pulmonary Hypertension
- How many people
- 490 participants
- Where
- 83 sitesin 20 countries
- Study dates
- Oct 2008to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with scleroderma in USA, Canada, UK, Germany, Switzerland, Austria, The Netherlands, Belgium, Sweden, Slovakia, and Turkey.
Who may be able to join
- Male or female
- Age ≥ 18 years
- Patients with definite diagnosis of SSc by American College of Rheumatology (ACR) criteria (18); including all patients with any other connective tissue diseases (CTD) who, in parallel, meet the ACR criteria for SSc (18)
- SSc disease duration > 3 years dated from onset of first non-Raynaud feature
- Diffusing capacity of the lung for carbon monoxide (DLCO) < 60% of predicted
Who cannot join
- PH confirmed by RHC before enrolment, i.e. mean pulmonary arterial pressure (mPAP) > or = 25 mmHg at rest or > or = 30 mmHg at exercise, independent of PCWP (11)
- RHC within the 12 months before enrolment
- Use of therapy that is considered definite PAH/PH treatment (19) for any indication, within the 6 weeks before enrolment and/or for a total of more than 6 weeks during the 12 months before enrolment: i.e. endothelin receptor antagonists (ERA; e.g. bosentan, sitaxsentan, ambrisentan), phosphodiesterase type 5 inhibitors (PDE5; e.g. sildenafil, tadalafil, vardenafil), prostanoids (e.g. epoprostenol, treprostinil, iloprost, beraprost), and any experimental PAH/PH drugs. Intermittent use of PDE5 inhibitors for male erectile dysfunction is permitted
- Forced vital capacity (FVC) < 40%
- Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) < 40 ml/min/1.73 m2 (20), assessed according to local practice
- Previous evidence or previous diagnosis of clinically relevant left heart disease and other relevant conditions, i.e. at least one of the following:
Show all 20Show fewer
- Previous ECHO with estimated left ventricular (LV) ejection fraction < 50%, previous history of cardiogenic pulmonary edema, increased size of left atrium (> 50 mm)
- Known significant diastolic dysfunction associated with clinical heart failure or PCWP > 15mmHg
- Known significant coronary disease or significant valvular heart disease
- Evidence of inadequately treated blood pressure, defined as > 160/90 mmHg and/or blood pressure during exercise > 220/120 mmHg (if evaluated)
- Known hypertrophic cardiomyopathy or left ventricular hypertrophy (interventricular septum thickness (IVS) or posterior wall thickness (PWD) > 1.2 cm)
- Patients referred with overt heart failure
- Known congenital heart defects such as single ventricle, transposition, or Eisenmenger physiology
- Previous closure of systemic pulmonary shunt, heart valve replacement, or cardiac transplantation
- Pregnancy: pregnancy testing in females with child-bearing potential is mandatory and must be done before enrolment
- Patients unlikely to be available for annual follow up over an anticipated 3 years of study (e.g. survival estimate, psychological, logistics; based on investigator discretion)
- Patients with clinically relevant left heart disease as defined above, diagnosed by ECHO at baseline (i.e. after enrolment), will be included in the study.
- Additional exclusion criteria after patient enrolment
- During the study, use of therapy that is considered definite PAH/PH treatment (19) is prohibited and will result in discontinuation of the patient from the study, unless the total treatment duration per year is less than 6 weeks. Intermittent use of PDE5 inhibitors for male erectile dysfunction is permitted.
- During the study, use of therapy that is considered definite PAH/PH treatment (19) is prohibited within the 6 weeks preceding the follow-up visits. Violation of this rule will result in discontinuation of the patient from the study.
Trial locations and contacts
83 sites in 20 countries.
83 sites in 20 countries
United States23 sites
The Center for Rheumatology
Albany, New York, 12206
University of Michigan Scleroderma Program
Ann Arbor, Michigan, 48106
John Hopkins, Division of Rheumatology
Baltimore, Maryland, 21224
University of Alabama at Birmingham, 311 THT
Birmingham, Alabama, 35294
Boston University School of Medicine
Boston, Massachusetts, 02118
Medical University of South Carolina, Division of Rheumatolgoy and Immunology
Charleston, South Carolina, 29425
Rheumatology, MC 733, The University of Illinois-Chicago
Chicago, Illinois, 60612
University of CT
Farmington, Connecticut, 06030
Michigan State University
Grand Rapids, Michigan, 49546
University of Florida
Jacksonville, Florida, 32209
Division of Rheumatology and Allergy - Clinical Immunology
Lake Success, New York, 11042
UCLA Division of Rheumatology
Los Angeles, California, 90095
Medical College of Wisconsin and Froedtert Hospital
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Mayo Clinic - Division of Rheumatology
Rochester, Minnesota, 55905
AAIR Research Center
Rochester, New York, 14618
Department of Critical Care - Virginia Mason Medical Center
Seattle, Washington, 98101
Arthritis Northwest
Spokane, Washington, 99204
Chief of Rheumatology
Toledo, Ohio, 43614
Harbor UCLA Medical Center
Torrance, California, 90509
Department of Rheumatology
Washington D.C., District of Columbia, 20007
Carolina Arthritis
Wilmington, North Carolina, 28401
Germany14 sites
Kerckhoff-Klinik GmbH - Abteilung Rheumatologie und Kliniscihe Immunologie
Bad Nauheim, 61231
Universitaetsmedizine Charite
Berlin, 10117
Universitaetsklinikum Bonnn
Bonn, 53105
Universitaetsklinikum Koeln
Cologne, 50924
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307
Medizinische Klinik 3, Rheumatologie, Immunologie und Onkologie
Erlangen, 91054
Goethe-Universitaet Frankfurt
Frankfurt, 60590
Medizinische Klinik der Albert-Ludwigs Universitaet Freiburg
Freiburg im Breisgau, 79106
Universitatsklinik Greifswald - Klinik fur Innere Medizin B
Greifswald, D-17487
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg
Universitaetsklinikum Leipzig
Leipzig, 04103
Medizinische Klinik und Poliklinik B, Rheumatologisch Immunologische Ambulanz
Münster, 48149
Brüder Krankenhaus
Trier
University Hospital Zurich
Zurich
Canada10 sites
Faculty of Medicine
Calgary, Alberta, T1Y 6J4
2E4.31 Walter Mackenzie Health Sciences Center
Edmonton, Alberta, T6G 2B7
Queen Elizabeth II Health Sciences Centre-VG Site
Halifax, Nova Scotia, B3H 2Y9
St. Joseph Health Care
London, Ontario, N6A 4V2
Hospital Notre-Dame
Montreal, Quebec, H2L 4M1
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
St. Paul's (Grey Nuns) Hospital
Saskatoon, Saskatchewan, S7K 0H6
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Regent Medical Building
Vancouver, British Columbia, V6K 2E1
University of Manitoba
Winnipeg, Manitoba, R3A 1M4
Brazil8 sites
Santa Casa de BH - Departamento de Reumatologia
Belo Horizonte, CEP: 30150-221 - BH
Clinical Hospital - UNICAMP University of Campinas
Campinas, CEP 13083-970
Clinical Hospital - Federal University of Parana State - Rheumatology and Systemic Sclerosis Department
Curitiba, CEP 80060-240
UFRJ - Serviço de Reumatologia
Ilha Do Fundão, CEP: 21941-590
Complexo Santa Casa de POA - Hospital Santa Clara
Porto Alegre, CEP 90020-160
Hospital São Lucas da PUCRS - Pontifícia Universidade Católica de Porto Alegre (PUCRS)
Porto Alegre, CEP 90610-000
Clinical Hospital - Medicine School of the University of Sao Paulo
São Paulo, CEP 01246 - 000
Clinical Hospital - Federal University of Medicine of Sao Paulo
São Paulo, CEP 04023 - 062
Turkey (Türkiye)5 sites
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
Adana
Ankara Numune Egitim ve Arastirma hastanesi
Ankara, 06100
Hacettepe Universitesi Tip Fakultesi
Ankara, 06100
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34390
Ege Universitesi
Izmir, 35100
Austria4 sites
Division of Pulmonology, MEDUK
Graz
Universitaetsklinik fuer Dermatologie und Venerologie
Innsbruck, A-6020
Abteilung für Dermatologie
Linz, A-4010
Univ - Klinik fuer Innere Medizin II, Abt. fuer Kardiologie - Medizinische Universitaetsklinik Wien
Vienna, A1090
Norway3 sites
Helse Bergen HF Haukeland Universitetssykehus
Bergen, 5053
Rikshospitalet, University hospital of Oslo - Rheumatology department
Oslo, 0027
St. Olav University Hospital - Rheumatologisk avdeling
Trondheim, 7030
Spain3 sites
HOSPITAL SANTA CREU i SANT PAU
Barcelona, 08025
Servicio de Medicina Interna Planta 2ºB
Bizkaia, 48903
Jefe de Servicio - Servicio de Rheumatología
Valencia, 46017
Hungary2 sites
Kardiovaszkuláris Ambulancia Kft.
Debrecen, 4032
Study site
Pécs, 7624
Bosnia and Herzegovina1 site
Clinic for Heart and Rheumatic Diseases
Sarajevo, 71 000
China1 site
Peking Union Medical College Hospital (West Campus) Chinese Academy of Medical Sciences
Beijing, 100032
Poland1 site
Prywatny Specjalistyczny Gabinet Profesora Stanislawa
Bialystok, PL-15-297
Russia1 site
State Institution "Institute of the Rheumatology of the Russian Academy of Medical Sciences"
Moscow, 115522
About this study
Official title: A Two-stage Prospective Observational Cohort Study in Scleroderma Patients to Evaluate Screening Tests and the Incidence of Pulmonary Arterial Hypertension and Pulmonary Hypertension
A two-stage prospective observational cohort study in scleroderma patients to evaluate screening tests and the incidence of pulmonary arterial hypertension and pulmonary hypertension
- Medical subject headings
- Scleroderma, Systemic, Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary arterial hypertension (PAH) confirmed by right heart catheterization (RHC)
Measured: Baseline and 3-year follow-up
Secondary outcomes (1)
Pulmonary hypertension (PH) confirmed by right heart catheterization (RHC)
Measured: Baseline and 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies 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
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706082
- Sponsor's protocol ID
- AC-052-510
- Acronym
- DETECT
- Status last verified
- Jun 2012
- First submitted
- 25 Jun 2008
- Last updated
- 25 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gopal DM, Doldt B, Finch K, Simms RW, Farber HW, Gokce N. Relation of novel echocardiographic measures to invasive hemodynamic assessment in scleroderma-associated pulmonary arterial hypertension. Arthritis Care Res (Hoboken). 2014 Sep;66(9):1386-94. doi: 10.1002/acr.22307.
PubMed 24515598
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-stage Prospective Observational Cohort Study in Scleroderma Patients to Evaluate Screening Tests and the Incidence of Pulmonary Arterial Hypertension and Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00706082
- Acronym / sponsor ID
- DETECT / AC-052-510
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 490 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Jun 2008 (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.
A two-stage prospective observational cohort study in scleroderma patients to evaluate screening tests and the incidence of pulmonary arterial hypertension and pulmonary hypertension
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with scleroderma in USA, Canada, UK, Germany, Switzerland, Austria, The Netherlands, Belgium, Sweden, Slovakia, and Turkey.
Key inclusion criteria (5 listed)
- Male or female
- Age ≥ 18 years
- Patients with definite diagnosis of SSc by American College of Rheumatology (ACR) criteria (18); including all patients with any other connective tissue diseases (CTD) who, in parallel, meet the ACR criteria for SSc (18)
- SSc disease duration > 3 years dated from onset of first non-Raynaud feature
- Diffusing capacity of the lung for carbon monoxide (DLCO) < 60% of predicted
Key exclusion criteria (20 listed)
- PH confirmed by RHC before enrolment, i.e. mean pulmonary arterial pressure (mPAP) > or = 25 mmHg at rest or > or = 30 mmHg at exercise, independent of PCWP (11)
- RHC within the 12 months before enrolment
- Use of therapy that is considered definite PAH/PH treatment (19) for any indication, within the 6 weeks before enrolment and/or for a total of more than 6 weeks during the 12 months before enrolment: i.e. endothelin receptor antagonists (ERA; e.g. bosentan, sitaxsentan, ambrisentan), phosphodiesterase type 5 inhibitors (PDE5; e.g. sildenafil, tadalafil, vardenafil), prostanoids (e.g. epoprostenol, treprostinil, iloprost, beraprost), and any experimental PAH/PH drugs. Intermittent use of PDE5 inhibitors for male erectile dysfunction is permitted
- Forced vital capacity (FVC) < 40%
- Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) < 40 ml/min/1.73 m2 (20), assessed according to local practice
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
Pulmonary arterial hypertension (PAH) confirmed by right heart catheterization (RHC)
Time frame: Baseline and 3-year follow-up
1 secondary outcome
Pulmonary hypertension (PH) confirmed by right heart catheterization (RHC)
Time frame: Baseline and 3-year follow-up
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
- Derived from this study: PubMed 24515598Gopal DM, Doldt B, Finch K, Simms RW, Farber HW, Gokce N. Relation of novel echocardiographic measures to invasive hemodynamic assessment in scleroderma-associated pulmonary arterial hypertension. Arthritis Care Res (Hoboken). 2014 Sep;66(9):1386-94. doi: 10.1002/acr.22307.
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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.
The record lists no contact. Use the official record to reach the sponsor.
83 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Pulmonary Arterial Hypertension, run by Actelion at 83 sites in 20 countries.
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 20 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: stopped early, as of the sponsor's last update on 25 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States, Germany, Canada, Brazil, Turkey (Türkiye) and 15 more countries. 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 was stopped early. Results are not available in the source record.
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?
Pulmonary arterial hypertension (PAH) confirmed by right heart catheterization (RHC) (time frame: Baseline and 3-year follow-up). 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 NCT00706082, which also lists 1 linked publication.
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 25 Jun 2012.