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RecruitingNCT01387035Updated Jul 14, 2022

Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases

An observational study in Connective Tissue Disease and Pulmonary Hypertension, sponsored by Heidelberg University. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-14.

Sponsored by Heidelberg University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Connective Tissue Disease
  • Pulmonary Hypertension
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In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 50 is below the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
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What researchers measure

Primary outcomes

  1. 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?

    Time frame: 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)

    Time frame: 3 years

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Study locations

1 of 1 sites recruiting
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References and documents

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 30615302 ↗
  • Nagel 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01387035
Lead sponsor
Heidelberg University
Responsible party
Prof. Dr. med. Ekkehard Gruenig (Prof. Dr. med. Ekkehard Grünig, Heidelberg University) — Principal investigator
First posted
Jul 4, 2011
Start date
Jan 2010
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jul 14, 2022

Study contacts

Ekkehard Grünig, MD, Prof.
Contact
ekkehard.gruenig@med.uni-heidelberg.de
+49 6221 396 8053
Christian Nagel, MD
study director · Center for pulmonary hypertension, Thoraxclinic Heidelberg
Ekkehard Grünig, Professor
study director · Center for pulmonary hypertension, Thoraxclinic Heidelberg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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