Characterizing HIV-related Diastolic Dysfunction

Heart Failure Clinical Trial

— HFN_HIV  

Official title:

Characterizing HIV-related Diastolic Dysfunction: A Cross Sectional Study Leveraging the NHLBI Heart Failure Clinical Research Network

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860156
• Other study ID #: Pro00074493
• Status: Completed
• Start date: November 15, 2016
• Est. completion date: February 9, 2018

Study information

• Verified date: February 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multicenter clinical trial of a cross section of HIV+ patients with and without diastolic dysfunction. Approximately 200 HAART-treated virally suppressed HIV+ subjects (100 HIV+/DD+ & 100 HIV+/DD-) will be enrolled. This study will evaluate biomarkers, phenomapping, metabolomics, cMRI, echocardiography to determine characteristics unique to this patient population.

Description:

With the advent of highly active antiretroviral therapy (HAART), human immuno¬deficiency virus (HIV) type 1 infection has become a chronic disease. The proportion of patients expected to survive 5, 10, and 15 years after conversion in the HAART era are 99%, 93% and 89% respectively. With increased life expectancy and decreased morbidity from opportunistic infections, the importance of chronic complications associated with HIV-1 infection, including HF is becoming more evident. The advent of HAART has altered the epidemiology of HIV associated cardiomyopathy evolving from a primarily left ventricular systolic dysfunction to the growing recognition of left ventricular DD. DD is associated with the development of atrial fibrillation and heart failure (HF), and portends higher risk for all-cause mortality. Thus there is a widespread prevalence of cardiac abnormalities in HIV infected individuals that are associated with HF development and may represent a sub-clinical abnormality that may be potentially intervened upon to reduce the risk of subsequent HF. There are little data to understand the natural history and pathogenesis of cardiac abnormalities, specifically DD in HIV+ individuals, which may adversely affect the longevity and quality of life of these individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: February 9, 2018
• Est. primary completion date: February 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Age >40 years

2. Willingness and ability to provide informed consent

3. HIV antibody positive

4. On HAART for >6 months (HIV positive cohort only)

5. History of adequate viral suppression as defined by HIV RNA level <200 copies/mL in the past 6 months

6. LVEF >50% -

Exclusion Criteria:

1. Past EF <50%

2. Moderate or severe valve stenosis or regurgitation, or past repair or replacement

3. Percutaneous or surgical revascularization or active angina

4. Persistent atrial fibrillation

5. BP>160mmHg SBP or >100mmHg DBP

6. Comorbid inflammatory disease (e.g. RA or SLE)

7. Active cancer or cancer chemotherapy treatment in the prior year (except skin cancer that did not require chemotherapy or radiation)

8. Chronic use of steroids or anti-inflammatory therapy

9. GFR <30 mL/min

10. Active in a clinical trial with investigational product

11. Pregnant or lactating females

12. Contraindication to cMR or gadolinium injection (such as severe claustrophobia, metal implants, etc.)

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Heart Failure
• HIV

Locations

Country	Name	City	State
United States	The Emory Clinic	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	The University of Vermont	Burlington	Vermont
United States	Northwestern University	Chicago	Illinois
United States	University Hospital Cleveland Medical Center	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Barnes-Jewish Hospital-Washington University Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	persistent inflammation between HIV+/DD- and HIV+/DD+ subjects	Compare inflammation between HIV+/DD- and HIV+/DD+ subjects.	baseline visit
Primary	immune activation between HIV+/DD- and HIV+/DD+ subjects	Compare immune activation between HIV+/DD- and HIV+/DD+ subjects.	baseline visit
Primary	inflammation between HIV+/DD- and HIV+/DD+ subjects	To compare inflammation between HIV+/DD- and HIV+/DD+	baseline visit
Primary	Perform phenomics of aggregate demographic data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects		baseline visit
Primary	myocardial fibrosis by magnetic resonance imaging between HIV+/DD- and HIV+/DD+	To compare myocardial fibrosis by magnetic resonance imaging between HIV+/DD- and HIV+/DD+	baseline visit
Primary	serum levels of biomarkers	To identify systemic determinants (biomarkers) of DD in HIV+ persons	baseline visit
Primary	novel mechanisms underlying DD in HIV+ subjects as measured by proteomic and metabolomics panels	To study the proteomic and metabolomics panels to enable identification of novel mechanisms underlying DD in HIV+ subjects	baseline visit
Primary	the effect of DD on mechanics of the left atrium in HIV	To study the effect of DD on mechanics using left atrial strain during passive leg raise	baseline visit
Primary	sub-clinical necrosis in HIV+/DD+ subjects	To study the sub-clinical necrosis using Troponin levels in HIV+/DD+ subjects	baseline visit
Primary	myocardial stress in HIV+/DD+ subjects	To study myocardial stress using NTProBNP levels in HIV+/DD+ subjects	baseline visit
Primary	Perform phenomics of aggregate clinical data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects	Clinical data	baseline visit
Primary	Perform phenomics of aggregate biomarker data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects	Biomarker data	baseline visit
Primary	Perform phenomics of aggregate electrocardiogram data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects	electrocardiogram data	baseline visit
Primary	Perform phenomics of aggregate imaging data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects	imaging data	baseline visit