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| Sponsor: | CardioDx |
|---|---|
| Information provided by: | CardioDx |
| ClinicalTrials.gov Identifier: | NCT00500708 |
Purpose
Heart failure (HF) affects 5 million Americans, with 500,000 new cases diagnosed and 250,000 deaths each year. The two major causes of morbidity and mortality in HF are pump failure and sudden, lethal ventricular arrhythmias, the latter of which accounts for 40-50% of HF deaths. Arrhythmias may be precipitated by a complex interaction of genetic and environmental factors. Establishing increased risk for arrhythmias before a severe life-threatening event is critically important. However, this remains a significant medical challenge.
Several genetic mutations associated with rare, inherited arrhythmia disorders have been identified. The aim of this study is to identify novel genetic and other biological markers that distinguish patients at increased risk for lethal ventricular arrhythmias in a broader population.
| Condition |
|---|
|
Arrhythmia |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patient's with ventricular dysfunction (low ejection fraction) undergoing implantation of ICD or CRT-D for primary prevention. Patient's may be enrolled at time of implant or during follow-up in electrophysiology clinic as long as full device records are available since time of implant.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Amy J Sehnert, MD | 650-475-2705 | asehnert@cardiodx.com |
| United States, Alaska | |
| Alaska Heart Institute | Recruiting |
| Anchorage, Alaska, United States, 99508 | |
| Principal Investigator: Steve Compton, MD | |
| United States, California | |
| Palo Alto Medical Foundation | Recruiting |
| Palo Alto, California, United States, 94301 | |
| Principal Investigator: Sun Chung, MD | |
| United States, Minnesota | |
| Minneapolis Heart Institute and Foundation | Recruiting |
| Minneapolis, Minnesota, United States, 55407 | |
| Principal Investigator: William Katsiyiannis, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Principal Investigator: Patrick Hranitzky, MD | |
| United States, Ohio | |
| Cleveland Clinic Foundation | Not yet recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: Steven Ellis, MD | |
| Sub-Investigator: Oussama Wazni, MD | |
| United States, Pennsylvania | |
| West Penn Allegheny Health System | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Principal Investigator: Christopher Bonnet, MD | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: Dawood Darbar, MD | |
| United States, Utah | |
| Intermountain Healthcare | Recruiting |
| Salt Lake City, Utah, United States, 84111 | |
| Principal Investigator: John Day, MD | |
| Study Director: | Amy J Sehnert, MD | CardioDx, Inc. |
More Information
| Responsible Party: | CardioDx, Inc. ( Amy Sehnert, MD; Director, Clinical R&D ) |
| Study ID Numbers: | CDx_000003 |
| Study First Received: | July 11, 2007 |
| Last Updated: | February 2, 2010 |
| ClinicalTrials.gov Identifier: | NCT00500708 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Heart failure Implanted Cardioverter Defibrillator Biological Markers Molecular Genetics |
|
Pathologic Processes Heart Diseases Cardiovascular Diseases Arrhythmias, Cardiac |
