{"type":"trials","record":{"id":32271,"source_id":"clinicaltrials-gov","external_id":"NCT01775865","title":"Targeting Inflammation to Treat Cardiovascular Aging","brief_summary":"Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States with older age being a primary risk factor. The number of adults greater than age 65 years will almost double to 70 million by 2030, therefore identifying therapeutic strategies for treating or preventing age-related disorders in humans is of major biomedical importance. Cardiovascular aging, defined as a reduction in vascular and cardiac functions with normal aging, occurs even in the absence of CVD risk factors and overt CVD. A key feature of cardiovascular aging is stiffening of the large elastic central arteries such as the aorta. This is important because aortic stiffness directly contributes to clinical problems such as increased blood pressure, reduced blood flow to the heart muscle, and thickening of the heart muscle. Therefore, these clinical consequences are hypothesized to mediate a substantial proportion of the increase in CVD risk in older adults. However, effective drug treatments for aortic stiffness are not currently available and the biological reasons (mechanisms) involved in causing aortic stiffening remain undefined. In addition, the inability of smaller blood vessels to relax, impairment of the heart to relax during the filling phase of the heart cycle (i.e., diastole), and increased blood pressure variability, have all been linked to aortic stiffness. Furthermore, chronic low-grade inflammation with advancing age has been proposed to be a common mechanistic link (i.e., biological reason) between these reductions in cardiovascular function in older adults. Therefore, the investigators propose that inflammation could be a novel therapeutic target to treat cardiovascular aging in older adults. Our central hypothesis is that inflammation mediates the age-related deterioration in cardiovascular functions observed with advancing age through the development of oxidative stress (i.e., imbalance between damaging oxygen free radicals vs. protective antioxidants). Our hypothesis predicts that chronic inhibition of inflammation with Salsalate, an FDA-approved anti-inflammatory drug similar to aspirin that is used to treat rheumatoid arthritis pain and known to inhibit the 'master' regulator of inflammation in the cell (i.e., nuclear factor kappa B), will improve cardiovascular function in older adults. In addition, the investigators hypothesize that the mechanism for the improvement in cardiovascular function during inhibition of inflammation will be by suppressing oxidative stress. To test our hypothesis, the investigators will randomize older healthy adults (age 50-79 years) to 3 g/day of salsalate or placebo (i.e., pill with inactive substance) pills for 4 weeks and have cardiovascular function measured at baseline and again after 4 weeks.","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Gary L. Pierce","enrollment":59,"countries":["United States"],"start_date":"2012-09-01","completion_date":"2016-02-01","last_update_date":"2018-05-31","source_url":"https://clinicaltrials.gov/study/NCT01775865","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:23.954312+00:00","last_seen_at":"2026-09-25T06:15:54.38+00:00","metadata":{"sex":"ALL","acronym":"TIVA","age_range":"18 Years to 79 Years","comparator":"Placebo; Young Control","organization":"University of Iowa","interventions":["Salsalate","Placebo (for salsalate)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Carotid-femoral Pulse Wave Velocity (CFPWV) — Change in CFPWV from baseline at 4 weeks","Brachial Artery Flow-mediated Dilation (FMD) — Change from baseline brachial artery FMD at 4 weeks"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":true},"controlled_terms":["Vascular Stiffness","Endothelial Dysfunction","Diastolic Dysfunction","Salsalate","Placebo (for salsalate)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: cardiovascular aging, vascular aging.","quality_checked_at":"2026-09-25T06:16:07.48358+00:00","duplicate_cluster_key":"id:nct01775865","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2012-09-01 to 2016-02-01","comparator":"Placebo; Young Control","confidence":"structured-source","population":"ALL · 18 Years to 79 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:15:54.487Z","intervention":["Salsalate","Placebo (for salsalate)"],"participants":59,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Carotid-femoral Pulse Wave Velocity (CFPWV) — Change in CFPWV from baseline at 4 weeks","Brachial Artery Flow-mediated Dilation (FMD) — Change from baseline brachial artery FMD at 4 weeks"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"cardiovascular-aging","is_published":true,"match_reasons":["Title contains controlled term: cardiovascular aging, vascular aging.","Abstract contains controlled term: cardiovascular aging, vascular aging.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Cardiovascular ageing","slug":"cardiovascular-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/32271","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}