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

NCT01387035 | Unknown

• 1 other identifier: S-360/2009
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Connective Tissue Disease; Pulmonary Hypertension

Outcome Measures

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?

  3 years

Secondary Outcomes (1)

• Subdivision of patients with connective tissue disease in different degrees of severity

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Heidelberg, 69126, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 30615302 DERIVED

• 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.

  PMID: 26084934 DERIVED

MeSH Terms

Conditions

Connective Tissue Diseases; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christian Nagel, MD

  Center for pulmonary hypertension, Thoraxclinic Heidelberg

  STUDY DIRECTOR

• Ekkehard Grünig, Professor

  Center for pulmonary hypertension, Thoraxclinic Heidelberg

  STUDY DIRECTOR

Central Study Contacts

Ekkehard Grünig, MD, Prof.

CONTACT

+49 6221 396 8053; ekkehard.gruenig@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Ekkehard Grünig

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 4, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

DE (1)