Clinical trial NCT03782870: Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis
Official title: Clinical and Echocardiographic Evaluation of Patients With Granulomatosis With Polyangiitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Granulomatosis With Polyangiitis
Atherosclerosis
Thrombosis
Keywords: granulomatosis with polyangitis, cardiac involvement
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed Granulomatosis with polyangitis who received initial treatment

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.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed Granulomatosis with polyangitis

Exclusion Criteria:

-

Primary outcomes:
measure: death from any cause
timeFrame: from date of randomization until the death from any cause, up to december 2018
Secondary outcomes:
measure: coronary artery disease
timeFrame: from date of randomization until the date of first documented coronary artery disease episodes up to december 2018
measure: stroke
timeFrame: from date of randomization until the date of documented stroke, up to december 2018
measure: deep vein thrombosis
timeFrame: from date of randomization until the date of documented deep vein thrombosis, up to december 2018
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Family Medicine, Internal and Metabolic Diseases
Study officials:
affiliation: Warsaw University of Medicine
name: Anna Borowiec, PhD
role: STUDY_CHAIR
References: