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

HIV Infections Clinical Trial

— HIV&HEART  

Official title:

A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk, New Cardiovascular Events and the Cardiovascular Diseases in HIV-infected Patients: 12,5 Year Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156048
• Other study ID #: 12-4970-BO B
• Status: Completed
• Start date: July 3, 2017
• Est. completion date: November 6, 2019

Study information

• Verified date: February 2020
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1809
• Est. completion date: November 6, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• AIDS Dementia Complex
• Brain Diseases
• Coronary Disease
• Heart Failure
• HIV Encephalopathy
• HIV Infections
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Germany	University Hospital of Bochum, Department of Dermatology	Bochum	NRW
Germany	HIV Outpatient Department	Dortmund
Germany	HIV physician pratice	Duisburg	NRW
Germany	Institut für Medizinische Informatik, Biometrie und Epidemiologie	Essen	Nordrhein-Westfalen
Germany	Universitätsklinikum Essen, Klinik für Dermatologie	Essen	Nordrheinwestfalen
Germany	Clinical Coordinating Center Leipzig	Leipzig	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Diseases in HIV-infected Patients		Baseline up to 12,5 year follow up
Secondary	Impact of classic cardiovascular risk factors of coronary artery disease, comorbidities and antiretroviral therapy		Baseline up to 12,5 year follow up
Secondary	Impact of new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy		Baseline up to 12,5 year follow up