Hemodynamic Changes in Connective Tissue Disease

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study serves the identification of early forms of pulmonary arterial hypertension (PAH) in connective tissue disease and the hemodynamic follow-up of the investigated patients. The basic hypothesis is that PAH may start with a remodeling of small pulmonary arteries, which leads to a stiffening of the vessels, indicated by the inability to vasodilatation and thus a disproportional increase in pulmonary pressure during exercise. Recent studies have shown that a proportion of such patients may develop manifest PAH within a few years. The early identification of these patients and the understanding of the natural course of the disease may improve prognosis. The aim of the present study is to investigate hemodynamic and clinical changes in patients with connective tissue disease in a time interval of 3-5 years with a focus on the development of pulmonary hypertension.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Inflammatory Profiling in Chronic Lung Disease

NCT04654767

Pulmonary Hypertension

RECRUITING

Smoking: a Risk Factor for Pulmonary Arterial Hypertension?

NCT01484899

Pulmonary Hypertension

COMPLETED

Exercise Hemodynamics in Patients With Pulmonary Fibrosis

NCT03706820

Exercise Pulmonary Hypertension

UNKNOWN

Clinical Registry for the Characterization of the 'Pulmonary Vascular Phenotype' in Patients With Chronic Obstructive Pulmonary Disease

NCT07102823

Chronic Obstructive Pulmonary Disease (COPD) Pulmonary Hypertension

RECRUITING

Natural History Study of Biomarkers in Pulmonary Arterial Hypertension

NCT01730092

Pulmonary Disease Pulmonary Hypertension

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Informed consent
* Patients with systemic sclerosis, mixed connective tissue disease, (systemic lupus erythematodes) SLE or overlap syndrome
* Existing exercise Doppler echocardiography or/and right heart catheterization 3-5 years before inclusion

Exclusion Criteria

* \- Severe lung or bronchial disease (FEV1 \<60%)
* Systolic LV dysfunction (LVEF \<50%) or diastolic dysfunction \> grade I
* Valvular defect \> grade I (except for tricuspid- or pulmonary insufficiency)
* Uncontrolled systemic arterial hypertension (at rest \>150 mmHg systolic or 95 mmHg diastolic)
* Uncontrolled ventricular arrhythmias
* Uncontrolled bradycardia or tachycardia supraventricular arrhythmias
* Myocardial infarction within the last 12 months
* Pulmonary embolism within the last 12 months
* Relevant changes in hemodynamic therapy or major surgery within the last 12 weeks
* Musculoskeletal or peripheral vessel disorders which complicates an ergometry

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No