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Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis

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ClinicalTrials.gov Identifier: NCT03782870
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Brief Summary:
Granulomatosis with polyangiitis (GPA) is one of antineutrophil cytoplasmic autoantibody (ANCA) - associated vasculitis. Inflammation-induced thrombosis is considered to be a feature of systemic autoimmune diseases. GPA usually involves the upper and lower respiratory tract and renal systems, where necrotizing glomerulonephritis and pulmonary capillaritis are often detected. However, it may also affect other organ systems. Cardiac involvement in GPA occurs in approximately 6% to 44% of cases and is secondary to necrotizing vasculitis with granulomatous infiltrates. Cardiac involvement is an independent predictor of mortality in GPA patients. In this prospective cohort study, consecutive GPA patients who were hospitalized in the Department of Family Medicine, Internal and Metabolic Diseases at the Medical University of Warsaw in Poland are included. In all patients echocardiography and laboratory tests are perform.

Condition or disease Intervention/treatment
Granulomatosis With Polyangiitis Atherosclerosis Thrombosis Diagnostic Test: echocardiography, lab tests

Detailed Description:
Granulomatosis with polyangiitis (Wegener's; GPA) is an antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), which also includes microscopic polyangiitis and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome). GPA is characterized by granulomatous inflammation and necrotizing vasculitis predominantly affecting small- to medium-sized blood vessels and the presence of ANCA directed to specific antigens, particularly proteinase 3 (PR3-ANCA) and myeloperoxidase (MPO-ANCA). The destructive inflammatory processes of GPA have a predilection for the upper and lower airways and the kidneys, but any organs can be affected. An increased incidence of various cardiovascular events has been demonstrated among GPA patients. Cardiac involvement is also an independent predictor of mortality in GPA patients. In this prospective cohort study, consecutive GPA patients who are hospitalized in the Department of Family Medicine, Internal and Metabolic Diseases at the Medical University of Warsaw in Poland are included. All patients are diagnosed with GPA according to current guidelines. Patients are entered into the study at the time point when a new diagnosis of GPA was established and received initial treatment at our centre. Data collection included a full interim medical history, physical examination, laboratory studies and review of adverse events. Additionally, in all patients an echocardiography is performed.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Echocardiographic Evaluation of Patients With Granulomatosis With Polyangiitis
Actual Study Start Date : February 1, 2010
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2019





Primary Outcome Measures :
  1. death from any cause [ Time Frame: from date of randomization until the death from any cause, up to december 2018 ]
    death


Secondary Outcome Measures :
  1. coronary artery disease [ Time Frame: from date of randomization until the date of first documented coronary artery disease episodes up to december 2018 ]
    coronarography

  2. stroke [ Time Frame: from date of randomization until the date of documented stroke, up to december 2018 ]
    CT scan

  3. deep vein thrombosis [ Time Frame: from date of randomization until the date of documented deep vein thrombosis, up to december 2018 ]
    Ultrasonography of the lower extremity veins



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed Granulomatosis with polyangitis who received initial treatment
Criteria

Inclusion Criteria:

  • Newly diagnosed Granulomatosis with polyangitis

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782870


Contacts
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Contact: Anna Borowiec, PhD +48225720913 ania_borowiec@yahoo.com

Locations
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Poland
Department of Family Medicine, Internal and Metabolic Diseases Recruiting
Warsaw, Poland
Contact: Anna Borowiec, PhD    48225720913    ania_borowiec@yahoo.com   
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Study Chair: Anna Borowiec, PhD Warsaw University of Medicine

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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03782870     History of Changes
Other Study ID Numbers: AKBE/130/2018
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of Warsaw:
granulomatosis with polyangitis, cardiac involvement

Additional relevant MeSH terms:
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Systemic Vasculitis
Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Thrombosis
Atherosclerosis
Granulomatosis with Polyangiitis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Autoimmune Diseases
Immune System Diseases