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NCT01807130 · ClinicalTrials.gov registry record · NA
Automated MEdical Record Driven Implantable CArdioverter-defibrillator Heart Failure Trial (AMERICA-HF)
A NA study, sponsored by Duke University.
- Terminated
- Registry status
- NA
- Development phase
- 77
- Enrollment target
NCT01807130 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 77 participants.
The verdict
NCT01807130, a NA study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- NA
- Development phase
- 77 participants
- Enrollment target
Study Summary
Purpose and Objective: Heart failure therapies including beta-blockers, ACE-inhibitors, aldosterone antagonists, implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) devices have proven beneficial but are underused in eligible patients. The investigators seek to determine if automating referral to cardiologists and electrophysiologists through an intelligent electronic medical record system can improve adherence to American College of Cardiology (ACC)/ American Heart Association (AHA) heart failure guideline recommended therapies. Study activities and population group: The AMERICA-HF trial will be a randomized, single-center, single blinded study comparing standard-practice provider initiated cardiovascular specialty referral to experimental automated medical record driven cardiovascular specialty referral. An investigational program will automatically screen all finalized electronic reports from clinically indicated transthoracic echocardiogram studies performed in the Duke University Echo Lab system and create an automated query to obtain HF ICD-9 codes. Eligible patients will be randomly assigned to participate in a registry (n=125) or automated electronic medical record (EMR) based subspecialty care intervention arm (n=125). Data analysis: The primary endpoint is rate of adherence (%) to ACC/AHA HF guideline recommended therapies at 3, 6, and 12 month follow-up among patients randomized to the registry compared to the intervention. Differences in characteristics (including use of guideline recommended therapies) will be tested using Pearson Chi-square tests for categorical variables and Wilcoxon two-sample tests for continuous variables. Time to event analysis will be performed for the secondary endpoints of hospitalization or death.
Interventions
- OTHER Automated HF/EP Referral
- OTHER Placebo (Registry Arm)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01807130
The ClinicalTrials.gov registry entry for NCT01807130 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Automated HF/EP Referral is the first listed.
NCT01807130 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01807130 about?
NCT01807130 is a clinical study titled "Automated MEdical Record Driven Implantable CArdioverter-defibrillator Heart Failure Trial (AMERICA-HF)". Purpose and Objective: Heart failure therapies including beta-blockers, ACE-inhibitors, aldosterone antagonists, implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) devices have proven beneficial but are underused in eligible patients. The investigators seek to d...
What is the current status of trial NCT01807130?
This trial is currently terminated. It is a NA study. The enrollment target is 77 participants. The study started on 2013-09. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01807130?
The interventions under investigation include: Automated HF/EP Referral (OTHER), Placebo (Registry Arm) (OTHER).
Who is sponsoring clinical trial NCT01807130?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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