Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04156048
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2019-10-21
Brief Title:
HIVHEART Aging Study 125 Year Follow up
Sponsor:
University Hospital Essen
Organization:
University Hospital Essen
Study Overview
Official Title:
A Prospective Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk New Cardiovascular Events and the Cardiovascular Diseases in HIV-infected Patients 125 Year Follow up
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIVHEART
Brief Summary:
The HIVHEART 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 125 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 200712243-248
Comprehensive non invasive cardiovascular examination
Anamnesis
File recherchePhysical 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
Comprehensive non invasive cardiovascular examination
Anamnesis
File recherchePhysical 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None