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

NCT04156048 | Completed

• 1 other identifier: 12-4970-BO B
• Study Type: observational
• Target: 1,809
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

HIV; AIDS; Antiretroviral therapy; Aging; Heart failure; coronary heart disease; myocardial infarction; HIV-associated neurocognitive disorders

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Diseases in HIV-infected Patients

  Baseline up to 12,5 year follow up

Secondary Outcomes (2)

• Impact of classic cardiovascular risk factors of coronary artery disease, comorbidities and antiretroviral therapy

  Baseline up to 12,5 year follow up

• Impact of new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy

  Baseline up to 12,5 year follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

population affected by HIV

You may qualify if:

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

You may not qualify if:

• Acute cardiovascular disease
• Pregnancy

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (6)

Universitätsklinikum Essen, Klinik für Dermatologie

Essen, Nordrheinwestfalen, 45147, Germany

Location

University Hospital of Bochum, Department of Dermatology

Bochum, North Rhine-Westphalia, 44791, Germany

Location

HIV physician pratice

Duisburg, North Rhine-Westphalia, 47259, Germany

Location

Institut für Medizinische Informatik, Biometrie und Epidemiologie

Essen, North Rhine-Westphalia, 45147, Germany

Location

Clinical Coordinating Center Leipzig

Leipzig, Saxony, 04107, Germany

Location

HIV Outpatient Department

Dortmund, 44137, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

stored blood samples

MeSH Terms

Conditions

HIV Infections; Coronary Disease; Myocardial Infarction; AIDS Dementia Complex; Heart Failure; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Slow Virus Diseases

Study Officials

• Stefan Esser, PD, MD

  Departement of dermatology and venerology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Stefan Esser

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: November 7, 2019
• Study Start: July 3, 2017
• Primary Completion: October 31, 2019
• Study Completion: November 6, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

DE (6)