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

NCT ID: NCT01387035

Last Updated: 2022-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Connective Tissue Disease Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Ekkehard Gruenig

Prof. Dr. med. Ekkehard Grünig

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Nagel, MD

Role: STUDY_DIRECTOR

Center for pulmonary hypertension, Thoraxclinic Heidelberg

Ekkehard Grünig, Professor

Role: STUDY_DIRECTOR

Center for pulmonary hypertension, Thoraxclinic Heidelberg

Locations

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Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ekkehard Grünig, MD, Prof.

Role: CONTACT

+49 6221 396 8053

Facility Contacts

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Christian Nagel, MD

Role: primary

+49 6221 396 8063

Ekkehard Grünig, Professor

Role: backup

+49 6221 396 8053

References

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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.

Reference Type DERIVED
PMID: 30615302 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26084934 (View on PubMed)

Other Identifiers

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S-360/2009

Identifier Type: -

Identifier Source: org_study_id

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