Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis

December 19, 2018 updated by: Medical University of Warsaw

Clinical and Echocardiographic Evaluation of Patients With Granulomatosis With Polyangiitis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Warsaw, Poland
        • Recruiting
        • Department of Family Medicine, Internal and Metabolic Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with newly diagnosed Granulomatosis with polyangitis who received initial treatment

Description

Inclusion Criteria:

  • Newly diagnosed Granulomatosis with polyangitis

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death from any cause
Time Frame: from date of randomization until the death from any cause, up to december 2018
death
from date of randomization until the death from any cause, up to december 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
coronary artery disease
Time Frame: from date of randomization until the date of first documented coronary artery disease episodes up to december 2018
coronarography
from date of randomization until the date of first documented coronary artery disease episodes up to december 2018
stroke
Time Frame: from date of randomization until the date of documented stroke, up to december 2018
CT scan
from date of randomization until the date of documented stroke, up to december 2018
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
from date of randomization until the date of documented deep vein thrombosis, up to december 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Anticipated)

December 30, 2018

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

December 13, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 20, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 19, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKBE/130/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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