HIV&HEART Aging Study (12,5 Year Follow up)

NCT ID: NCT04156048

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1809 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-03
• Study Completion Date: 2019-11-06

Brief Summary

The HIV/HEART Aging study (HIVH) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (CVD) in HIV-infected patients. The study population includes outpatients from specialized HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. From March 2004 (Pilot phase) to October 2019 (12,5 year Follow-up) 1806 HIV+ patients were recruited in a consecutive manner. The standardised examinations included a targeted assessment of medical history and physical examination. Blood was drawn for comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters). Furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic echocardiography (TTE). Examinations were completed in accordance with previously defined standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.

Detailed Description

A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

Comprehensive non invasive cardiovascular examination

• Anamnesis
• File recherche,Physical examination
• Documentation of the cardiovascular and antiretroviral medical therapy
• Electrocardiogram
• Transthoracic echocardiography
• Exercise electrocardiogram
• Exercise Montreal Cognitive Assessment test
• Exercise the Grooved Pegboard test
• Blood collection
• Questionnaire to quality of life and health economics

Conditions

HIV Infections; Coronary Disease; Myocardial Infarction; HIV Encephalopathy; Aging; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Known HIV-infection
• Signed informed consent

Exclusion Criteria

• Acute cardiovascular disease
• Unstable hemodynamic status in the three weeks before inclusion
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Stefan Esser M.D.

PD Dr. med. Stefan Esser

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Esser, PD, MD

Role: PRINCIPAL_INVESTIGATOR

Departement of dermatology and venerology

Locations

Universitätsklinikum Essen, Klinik für Dermatologie

Essen, Nordrheinwestfalen, Germany

University Hospital of Bochum, Department of Dermatology

Bochum, North Rhine-Westphalia, Germany

HIV physician pratice

Duisburg, North Rhine-Westphalia, Germany

Institut für Medizinische Informatik, Biometrie und Epidemiologie

Essen, North Rhine-Westphalia, Germany

Clinical Coordinating Center Leipzig

Leipzig, Saxony, Germany

HIV Outpatient Department

Dortmund, , Germany

Countries

Germany

Other Identifiers

12-4970-BO B

Identifier Type: -

Identifier Source: org_study_id