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

February 4, 2020 updated by: Stefan Esser M.D., University Hospital, Essen

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

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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

1809

Contacts and Locations

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

Study Locations

  • Germany
      • Dortmund, Germany, 44137
        • HIV Outpatient Department
    • NRW
      • Bochum, NRW, Germany, 44791
        • University Hospital of Bochum, Department of Dermatology
      • Duisburg, NRW, Germany, 47259
        • HIV physician pratice
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • Institut für Medizinische Informatik, Biometrie und Epidemiologie
    • Nordrheinwestfalen
      • Essen, Nordrheinwestfalen, Germany, 45147
        • Universitätsklinikum Essen, Klinik für Dermatologie
    • Sachsen
      • Leipzig, Sachsen, Germany, 04107
        • Clinical Coordinating Center Leipzig

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

Probability Sample

Study Population

population affected by HIV

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular Diseases in HIV-infected Patients
Time Frame: Baseline up to 12,5 year follow up
Baseline up to 12,5 year follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of classic cardiovascular risk factors of coronary artery disease, comorbidities and antiretroviral therapy
Time Frame: Baseline up to 12,5 year follow up
Baseline up to 12,5 year follow up
Impact of new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy
Time Frame: Baseline up to 12,5 year follow up
Baseline up to 12,5 year follow up

Collaborators and Investigators

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

Sponsor

University Hospital, Essen

Investigators

  • Principal Investigator: Stefan Esser, PD, MD, Departement of dermatology and venerology

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)

July 3, 2017

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

November 6, 2019

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-4970-BO B

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.

Clinical Trials on Myocardial Infarction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe