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NCT00141778 · ClinicalTrials.gov registry record · Phase 2

Renin-angiotensin-aldosterone System (RAAS), Inflammation, and Post-Operative Atrial Fibrillation (AF)

A Phase 2 study of Atrial Fibrillation, sponsored by Vanderbilt University.

Completed
Registry status
Phase 2
Development phase
455
Enrollment target
1
Study location

NCT00141778 is a Phase 2 study of Atrial Fibrillation that has completed, run by Vanderbilt University. The registered enrollment target is 455 participants, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00141778, a Phase 2 study of Atrial Fibrillation, has completed, sponsored by Vanderbilt University.

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

Study Summary

Atrial fibrillation (AF) is the most prevalent, sustained type of irregular heartbeat and affects over 2 million Americans. Post-operative AF, which leads to significant morbidity and a prolonged hospital stay, complicates 20% to 40% of cardiopulmonary bypass (CPB) surgical procedures. While recent studies indicate that interruption of the renin-angiotensin-aldosterone system by either angiotensin-converting enzyme (ACE) inhibition or AT1 receptor antagonism decreases the incidence of AF following a heart attack or cardioversion (electric shock to the heart), its effect on the incidence of post-operative AF has not been throughly studied. Studies in both animals and humans suggest that inflammation-induced atrial remodeling plays an important role in the cause of AF. Recent studies also provide evidence that activation of the renin-angiotensin-aldosterone system induces inflammation, myocyte injury, proarrhythmic electrical remodeling, and fibrosis through aldosterone.

Conditions Studied

Atrial Fibrillation

Interventions

  • DRUG Placebo
  • DRUG Spironolactone
  • DRUG Ramipril

Study Locations (1)

Tennessee

  • Vanderbilt University - Nashville

Trial Details

FieldValue
Enrollment Target 455 participants
Start Date 2005-04
Est. Completion 2010-08
Phase Phase 2

Sponsor

Vanderbilt University

430 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00141778

The ClinicalTrials.gov registry entry for NCT00141778 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 455 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (85% lower). The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00141778 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT00141778 about?

NCT00141778 is a clinical study titled "Renin-angiotensin-aldosterone System (RAAS), Inflammation, and Post-Operative Atrial Fibrillation (AF)". Atrial fibrillation (AF) is the most prevalent, sustained type of irregular heartbeat and affects over 2 million Americans. Post-operative AF, which leads to significant morbidity and a prolonged hospital stay, complicates 20% to 40% of cardiopulmonary bypass (CPB) surgical procedures. While recent ...

What is the current status of trial NCT00141778?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 455 participants. The study started on 2005-04. Estimated completion is 2010-08.

What conditions does trial NCT00141778 study?

This clinical trial studies the following conditions: Atrial Fibrillation.

What interventions are being tested in trial NCT00141778?

The interventions under investigation include: Placebo (DRUG), Spironolactone (DRUG), Ramipril (DRUG).

Who is sponsoring clinical trial NCT00141778?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00141778 being conducted?

This trial has 1 study location across Tennessee. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.