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NCT01775865 · ClinicalTrials.gov registry record · Phase 2

Targeting Inflammation to Treat Cardiovascular Aging

A Phase 2 study of Endothelial Dysfunction and Vascular Stiffness, sponsored by Gary L. Pierce.

Completed
Registry status
Phase 2
Development phase
59
Enrollment target
1
Study location

NCT01775865 is a Phase 2 study of Endothelial Dysfunction and Vascular Stiffness that has completed, run by Gary L. Pierce. The registered enrollment target is 59 participants, below the 91-participant average among 45 other Endothelial Dysfunction trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01775865, a Phase 2 study of Endothelial Dysfunction and Vascular Stiffness, has completed, sponsored by Gary L. Pierce.

COMPLETED
Registry status
Phase 2
Development phase
59 participants
Enrollment target
1
Study location

Study 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 antioxida

Interventions

  • DRUG Salsalate
  • DRUG Placebo (for salsalate)

Study Locations (1)

Iowa

  • University of Iowa - Iowa City

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2012-09
Est. Completion 2016-02
Phase Phase 2

Sponsor

Gary L. Pierce

4 total trials

What the Registry Record Tells You About NCT01775865

The ClinicalTrials.gov registry entry for NCT01775865 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 45 other Endothelial Dysfunction trials with a reported enrollment target (35% lower). The listed sponsor is Gary L. Pierce, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Endothelial Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which Salsalate is the first listed.

NCT01775865 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.

Frequently Asked Questions

What is clinical trial NCT01775865 about?

NCT01775865 is a clinical study titled "Targeting Inflammation to Treat Cardiovascular Aging". 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 preventi...

What is the current status of trial NCT01775865?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2012-09. Estimated completion is 2016-02.

What conditions does trial NCT01775865 study?

This clinical trial studies the following conditions: Endothelial Dysfunction, Vascular Stiffness, Diastolic Dysfunction.

What interventions are being tested in trial NCT01775865?

The interventions under investigation include: Salsalate (DRUG), Placebo (for salsalate) (DRUG).

Who is sponsoring clinical trial NCT01775865?

This trial is sponsored by Gary L. Pierce, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01775865 being conducted?

This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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