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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

Tracking Information
First Submitted Date December 13, 2018
First Posted Date December 20, 2018
Last Update Posted Date December 20, 2018
Actual Study Start Date February 1, 2010
Estimated Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2018)
death from any cause [ Time Frame: from date of randomization until the death from any cause, up to december 2018 ]
death
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 19, 2018)
  • coronary artery disease [ Time Frame: from date of randomization until the date of first documented coronary artery disease episodes up to december 2018 ]
    coronarography
  • stroke [ Time Frame: from date of randomization until the date of documented stroke, up to december 2018 ]
    CT scan
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis
Official Title Clinical and Echocardiographic Evaluation of Patients With Granulomatosis With Polyangiitis
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with newly diagnosed Granulomatosis with polyangitis who received initial treatment
Condition
  • Granulomatosis With Polyangiitis
  • Atherosclerosis
  • Thrombosis
Intervention Diagnostic Test: echocardiography, lab tests
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 19, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2019
Estimated Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Newly diagnosed Granulomatosis with polyangitis

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Anna Borowiec, PhD +48225720913 ania_borowiec@yahoo.com
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03782870
Other Study ID Numbers AKBE/130/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Medical University of Warsaw
Study Sponsor Medical University of Warsaw
Collaborators Not Provided
Investigators
Study Chair: Anna Borowiec, PhD Warsaw University of Medicine
PRS Account Medical University of Warsaw
Verification Date December 2018