Connective Tissue DiseaseNCT01387035
Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases
An observational study of Connective Tissue Disease and Pulmonary Hypertension, run by Heidelberg University at 1 site in Germany.
Trial summary
The purposes of this study are (I), to evaluate various screening methods for their ability to predict and to confirm Pulmonary Hypertension (PH) in scleroderma patients, and (II) to evaluate the incidence of PH (i.e. the number of new cases per year) in scleroderma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Connective Tissue Disease, Pulmonary Hypertension
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Dec 2025
- 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: Included are all patients who fulfill the current definition of a collagen vascular disease according to the actual guidelines of the American College of Rheumatology (ACR) and who are 18 years or older.
Who may be able to join
- consent form
- men and women> 18 years
- fulfill the current definition of a collagen vascular disease according to the actual guidelines of the American College of Rheumatology (ACR)
Who cannot join
- all contraindications for exercise testing
- significant restriction of the left ventricle, unstable coronary artery disease and myocardial infarction in the last 6 months
- patients with other lung diseases (as the pulmonary infestations as part of systemic disease) or related musculoskeletal disorders influencing baseline exercise capacity
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Center for pulmonary Hypertension, Thoraxclinic Heidelberg
Heidelberg, 69126
Christian Nagel, MD, +49 6221 396 8063, christian.nagel@thoraxklinik-heidelberg.de
Ekkehard Grünig, Professor, +49 6221 396 8053, ekkehard.gruenig@thoraxklinik-heidelberg.de
About this study
The purposes of this study are (I), to evaluate various screening methods for their ability to predict and to confirm Pulmonary Hypertension (PH) in scleroderma patients, and (II) to evaluate the incidence of PH (i.e. the number of new cases per year) in scleroderma patients.
- Conditions
- Connective Tissue Disease, Pulmonary Hypertension
- Medical subject headings
- Connective Tissue Diseases, Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients
Correlate Spiroergometric, lung functional Magnetic Resonance Imaging (MRI) and echocardiographic parameters with invasive hemodynamic findings collected by right heart catheterization: which other non-invasive parameters can be found to detect pulmonary hypertension? Can pulmonary hypertension be detected at rest in the echocardiography? In which patients can only stress-Doppler echocardiography confirm manifest or latent pulmonary hypertension? Is stress-Doppler echocardiography a suitable for early detection of pulmonary hypertension in patients with collagen vascular disease?
Measured: 3 years
Secondary outcomes (1)
Subdivision of patients with connective tissue disease in different degrees of severity
Can spiroergometric findings help to subdivide patients with connective tissue diseases into groups according to degrees of severity, and differ the patients based on spiroergometric findings? To what extent is this distinction comparable with the classifications for the "functional classes" (application for PH according to the New York Heart Association (NYHA) classification)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Connective Tissue DiseaseStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
- Investigators
- Christian Nagel, MD, Study director, Center for pulmonary hypertension, Thoraxclinic HeidelbergEkkehard Grünig, Professor, Study director, Center for pulmonary hypertension, Thoraxclinic Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387035
- Sponsor's protocol ID
- S-360/2009
- Status last verified
- Jul 2022
- First submitted
- 29 Jun 2011
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Nagel C, Marra AM, Benjamin N, Blank N, Cittadini A, Coghlan G, Distler O, Denton CP, Egenlauf B, Fiehn C, Fischer C, Harutyunova S, Hoeper MM, Lorenz HM, Xanthouli P, Bossone E, Grunig E. Reduced Right Ventricular Output Reserve in Patients With Systemic Sclerosis and Mildly Elevated Pulmonary Artery Pressure. Arthritis Rheumatol. 2019 May;71(5):805-816. doi: 10.1002/art.40814. Epub 2019 Apr 10.
PubMed 30615302Nagel C, Henn P, Ehlken N, D'Andrea A, Blank N, Bossone E, Bottger A, Fiehn C, Fischer C, Lorenz HM, Stockl F, Grunig E, Egenlauf B. Stress Doppler echocardiography for early detection of systemic sclerosis-associated pulmonary arterial hypertension. Arthritis Res Ther. 2015 Jun 19;17(1):165. doi: 10.1186/s13075-015-0673-7.
PubMed 26084934
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases
- ClinicalTrials.gov ID
- NCT01387035
- Acronym / sponsor ID
- S-360/2009
- Conditions
- Connective Tissue Disease, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Jul 2011 (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 purposes of this study are (I), to evaluate various screening methods for their ability to predict and to confirm Pulmonary Hypertension (PH) in scleroderma patients, and (II) to evaluate the incidence of PH (i.e. the number of new cases per year) in scleroderma patients.
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
- Included are all patients who fulfill the current definition of a collagen vascular disease according to the actual guidelines of the American College of Rheumatology (ACR) and who are 18 years or older.
Key inclusion criteria (3 listed)
- consent form
- men and women> 18 years
- fulfill the current definition of a collagen vascular disease according to the actual guidelines of the American College of Rheumatology (ACR)
Key exclusion criteria (4 listed)
- all contraindications for exercise testing
- significant restriction of the left ventricle, unstable coronary artery disease and myocardial infarction in the last 6 months
- patients with other lung diseases (as the pulmonary infestations as part of systemic disease) or related musculoskeletal disorders influencing baseline exercise capacity
- pregnancy
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
Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients
Time frame: 3 years
Correlate Spiroergometric, lung functional Magnetic Resonance Imaging (MRI) and echocardiographic parameters with invasive hemodynamic findings collected by right heart catheterization: which other non-invasive parameters can be found to detect pulmonary hypertension? Can pulmonary hypertension be detected at rest in the echocardiography? In which patients can only stress-Doppler echocardiography confirm manifest or latent pulmonary hypertension? Is stress-Doppler echocardiography a suitable for early detection of pulmonary hypertension in patients with collagen vascular disease?
1 secondary outcome
Subdivision of patients with connective tissue disease in different degrees of severity
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Derived from this study: PubMed 30615302Nagel C, Marra AM, Benjamin N, Blank N, Cittadini A, Coghlan G, Distler O, Denton CP, Egenlauf B, Fiehn C, Fischer C, Harutyunova S, Hoeper MM, Lorenz HM, Xanthouli P, Bossone E, Grunig E. Reduced Right Ventricular Output Reserve in Patients With Systemic Sclerosis and Mildly Elevated Pulmonary Artery Pressure. Arthritis Rheumatol. 2019 May;71(5):805-816. doi: 10.1002/art.40814. Epub 2019 Apr 10.
- Derived from this study: PubMed 26084934Nagel C, Henn P, Ehlken N, D'Andrea A, Blank N, Bossone E, Bottger A, Fiehn C, Fischer C, Lorenz HM, Stockl F, Grunig E, Egenlauf B. Stress Doppler echocardiography for early detection of systemic sclerosis-associated pulmonary arterial hypertension. Arthritis Res Ther. 2015 Jun 19;17(1):165. doi: 10.1186/s13075-015-0673-7.
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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.
Christian Nagel, MD study director
Center for pulmonary hypertension, Thoraxclinic Heidelberg
Ekkehard Grünig, Professor study director
Center for pulmonary hypertension, Thoraxclinic Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Connective Tissue Disease and Pulmonary Hypertension, run by Heidelberg University at 1 site in Germany.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ekkehard Grünig, MD, Prof. (+49 6221 396 8053, ekkehard.gruenig@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients (time frame: 3 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 NCT01387035, which also lists 2 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 14 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.