Clinical trial NCT01387035: Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases
Official title: Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Connective Tissue Disease
Pulmonary Hypertension
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients
timeFrame: 3 years
Secondary outcomes:
measure: Subdivision of patients with connective tissue disease in different degrees of severity
timeFrame: 3 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Center for pulmonary Hypertension, Thoraxclinic Heidelberg
Study officials:
affiliation: Center for pulmonary hypertension, Thoraxclinic Heidelberg
name: Christian Nagel, MD
role: STUDY_DIRECTOR
affiliation: Center for pulmonary hypertension, Thoraxclinic Heidelberg
name: Ekkehard Grünig, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.