Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis

Related Clinical Trial
Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis Hydroxychloroquine in ANCA Vasculitis Evaluation Vasculitis Illness Perception (VIP) Study Reproductive Health in Men and Women With Vasculitis Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis Impact of Vasculitis on Employment and Income Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases VCRC Tissue Repository Yellow Fever Vaccine in Patients With Rheumatic Diseases Journey of Patients With Vasculitis From First Symptom to Diagnosis One-Time DNA Study for Vasculitis Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. Clinical Transcriptomics in Systemic Vasculitis (CUTIS) The ANCA Vasculitis Questionnaire (AAV-PRO©) Vasculitis Pregnancy Registry VCRC Patient Contact Registry Patient-Reported Data Validation Study Educational Needs of Patients With Systemic Vasculitis Diagnostic Effectiveness of Virtual Bronchoscopy Alemtuzumab for ANCA Associated Refractory Vasculitis Interventional Cryotherapy for the Eradication of Benign Airway Disease (“ICE the BAD”) PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides Plasma Exchange for Renal Vasculitis PRO Development for ANCA Associated Vasculitis BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides Pulse Versus Continuous Cyclophosphamide for Induction of Remission in ANCA-Associated Vasculitides Rituximab Vasculitis Maintenance Study Anti-Cytokine Therapy for Vasculitis Rituximab and Belimumab Combination Therapy in PR3 COMBIVAS American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis Low-dose Glucocorticoid Vasculitis Induction Study Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis. The Assessment of Prednisone In Remission Trial (TAPIR) – Patient Centric Approach Steroids and Methotrexate to Treat Systemic Vasculitis Efficacy Study of Two Treatments in the Remission of Vasculitis Assessment of Lung Inflammation in Patients With Atopic Asthma Using Positron Emission Tomography The Assessment of Prednisone In Remission Trial – Centers of Excellence Approach Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener’s) Rituximab for the Treatment of Wegener’s Granulomatosis and Microscopic Polyangiitis Cyclophosphamide and Prednisone Followed by Methotrexate To Treat Vasculitides Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener’s) or Microscopic Polyangiitis Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener’s) and Microscopic Polyangiitis Mycophenolate Mofetil for Treatment of Relapses of Wegener’s Disease or Microscopic Polyangiitis (MPA) Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) Daclizumab to Treat Wegener’s Granulomatosis An Open Label Pilot Study Examining the Use of Rituximab in Patients With Wegener’s Granulomatosis Who Have Experienced Disease Relapse on Standard Therapies Etanercept to Treat Wegener’s Granulomatosis Treatment of Wegener’s Granulomatosis With Cyclophosphamide Mycophenolate Mofetil to Treat Wegener’s Granulomatosis and Related Vascular Inflammatory Conditions Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener’s Granulomatosis Comparison of Treatments to Maintain Disease Remission in Patients With Wegener’s Granulomatosis and Related Vasculitis Syndromes Neutrophils as Prognostic Factors in Granulomatosis With Polyangiitis (Formerly Named Wegener’s Granulomatosis) Natural History of Granulomatosis With Polyangiitis: Clinical and Genetic Biomarkers of Airway Disease NoAAC PR-03 Study Analysis of Bronchial Tissue and Fluid in Patients With Wegener’s Granulomatosis TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener’s) or Microscopic Polyangiitis Study of One Protein Implicated in Wegener Disease Abatacept in Treating Adults With Mild Relapsing Wegener’s Granulomatosis Phase II Study on Gusperimus in Patients With Refractory Wegener’s Granulomatosis Etanercept for Wegener’s Granulomatosis Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener’s Granulomatosis

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


Primary Outcome

death from any cause

Secondary Outcome

 coronary artery disease

Condition

Granulomatosis With Polyangiitis

Intervention

echocardiography, lab tests


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

100

Start Date

February 1, 2010

Completion Date

December 30, 2019

Primary Completion Date

December 30, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Newly diagnosed Granulomatosis with polyangitis

        Exclusion Criteria:

        -
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anna Borowiec, PhD, +48225720913, [email protected]

Location Countries

Poland

Location Countries

Poland

Administrative Informations


NCT ID

NCT03782870

Organization ID

AKBE/130/2018


Responsible Party

Sponsor

Study Sponsor

Medical University of Warsaw


Study Sponsor

Anna Borowiec, PhD, Study Chair, Warsaw University of Medicine


Verification Date

December 2018