Targeting Inflammation to Treat Cardiovascular Aging (TIVA)
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|ClinicalTrials.gov Identifier: NCT01775865|
Recruitment Status : Completed
First Posted : January 25, 2013
Results First Posted : May 31, 2018
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vascular Stiffness Endothelial Dysfunction Diastolic Dysfunction||Drug: Salsalate Drug: Placebo (for salsalate)||Phase 2|
Aim 1: To measure aortic wall stiffness and circulating biomarkers of oxidative stress during both acute (IV) intravenous infusions of saline and then the antioxidant vitamin C at baseline and after 4 weeks of salsalate or placebo in healthy older adults. Hypothesis 1: Inhibition of inflammation in older adults will decrease aortic wall stiffness in part by reductions in oxidative stress.
Aim 2: To measure brachial artery endothelium-dependent vasodilation (EDV) and circulating markers of oxidative stress during acute intravenous infusions of saline and then the vitamin C at baseline and after 4 weeks of salsalate or placebo in healthy older adults. Hypothesis 2: Inhibition of inflammation in older adults will improve vascular endothelial vasodilatory function in older adults in part by reductions in oxidative stress.
Aim 3: To measure left ventricular (LV) diastolic relaxation and filling dynamics and circulating markers of oxidative stress during both acute intravenous infusions of saline and then vitamin C at baseline and after 4 weeks of Salsalate or placebo in healthy older adults. Hypothesis 3: Inhibition of inflammation in older adults will improve LV diastolic function in part by reductions in oxidative stress.
Exploratory Aim: To measure 24-hour pressure variability and short-term baroreflex sensitivity before and after 4 weeks of oral Salsalate or placebo treatment in older adults. Exploratory hypothesis: Inhibition of inflammation in older adults will improve cardiovascular autonomic dysregulation in older healthy adults.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Targeting Inflammation to Treat Cardiovascular Aging in Humans (TIVA Study)|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Salsalate capsule 1.5 g/day twice per day by mouth for 4 weeks
4 weeks of daily salsalate
Placebo Comparator: Placebo
Placebo capsule twice per day by mouth for 4 weeks
Drug: Placebo (for salsalate)
4 week of daily placebo
Other Name: Placebo capsule sugar pill to mimic salsalate
No Intervention: Young Control
No intervention; Baseline measurements only
- Carotid-femoral Pulse Wave Velocity (CFPWV) [ Time Frame: Change in CFPWV from baseline at 4 weeks ]Aortic stiffness
- Brachial Artery Flow-mediated Dilation (FMD) [ Time Frame: Change from baseline brachial artery FMD at 4 weeks ]Endothelial function
- Tissue Doppler Left Ventricular Relaxation Velocity (E') [ Time Frame: Change from baseline E' at 4 weeks ]Left ventricular diastolic dysfunction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775865
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Gary L Pierce, PhD||University of Iowa|