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Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis

Clinical and Echocardiographic Evaluation of Patients With Granulomatosis With Polyangiitis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03782870
Enrollment
100
Registered
2018-12-20
Start date
2010-02-01
Completion date
2019-12-30
Last updated
2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Granulomatosis With Polyangiitis, Thrombosis

Keywords

granulomatosis with polyangitis, cardiac involvement

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.

Interventions

DIAGNOSTIC_TESTechocardiography, lab tests

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Newly diagnosed Granulomatosis with polyangitis

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
death from any causefrom date of randomization until the death from any cause, up to december 2018death

Secondary

MeasureTime frameDescription
coronary artery diseasefrom date of randomization until the date of first documented coronary artery disease episodes up to december 2018coronarography
strokefrom date of randomization until the date of documented stroke, up to december 2018CT scan
deep vein thrombosisfrom date of randomization until the date of documented deep vein thrombosis, up to december 2018Ultrasonography of the lower extremity veins

Countries

Poland

Contacts

Primary ContactAnna Borowiec, PhD
ania_borowiec@yahoo.com+48225720913

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026