Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis

Atherosclerosis Clinical Trial

Official title:

Clinical and Echocardiographic Evaluation of Patients With Granulomatosis With Polyangiitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03782870
• Other study ID #: AKBE/130/2018
• Status: Recruiting
• Start date: February 1, 2010
• Est. completion date: December 30, 2019

Study information

• Verified date: December 2018
• Source: Medical University of Warsaw
• Contact: Anna Borowiec, PhD
• Phone: +48225720913
• Email: ania_borowiec[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed Granulomatosis with polyangitis

Exclusion Criteria:

Related Conditions & MeSH terms

• Atherosclerosis
• Granulomatosis with Polyangiitis
• Systemic Vasculitis
• Thrombosis

Intervention

Diagnostic Test:
• echocardiography, lab tests

Locations

Country	Name	City	State
Poland	Department of Family Medicine, Internal and Metabolic Diseases	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death from any cause	death	from date of randomization until the death from any cause, up to december 2018
Secondary	coronary artery disease	coronarography	from date of randomization until the date of first documented coronary artery disease episodes up to december 2018
Secondary	stroke	CT scan	from date of randomization until the date of documented stroke, up to december 2018
Secondary	deep vein thrombosis	Ultrasonography of the lower extremity veins	from date of randomization until the date of documented deep vein thrombosis, up to december 2018