Congestive heart failure is a common and lethal disease. Patients with moderate left ventricular dysfunction have a 25% mortality over 2.4 years. Fifty percent of these deaths are sudden and presumed arrhythmias in the majority of these sudden deaths. The hypothesis of this study is that Amiodarone or an implantable cardioverter-defibrilator will improve survival compared to placebo in patients with New York Heart Association Class II or III congestive heart failure and a left ventricular ejection fraction of less that or equal to 35%. This is a three arm study. Patients ramdomized to the first arm, """"""""Conventional therapy"""""""", will receive standard CHF therapy including ACE inhibitors. The second arm, """"""""Amiodarone vs. placebo"""""""", will be randomized to receive amiodarone vs. placebo. The third arm is, """"""""implantable cardioverter-defibrillator (ICD)"""""""". Patients in this limb will receive a single lead device which will monitor for ventricular arrhythmias and will deliver a high voltage shock to return the rhythm to the normal one. This study may allow primary prevention of arrhythmic death in patients at high risk of this problem: patients with congestive heart failure.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-39
Application #
6441941
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
39
Fiscal Year
2001
Total Cost
Indirect Cost
Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762
Inker, Lesley A; Grams, Morgan E; Levey, Andrew S et al. (2018) Relationship of Estimated GFR and Albuminuria to Concurrent Laboratory Abnormalities: An Individual Participant Data Meta-analysis in a Global Consortium. Am J Kidney Dis :
Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671
Bustos, Martha L; Caritis, Steve N; Jablonski, Kathleen A et al. (2017) The association among cytochrome P450 3A, progesterone receptor polymorphisms, plasma 17-alpha hydroxyprogesterone caproate concentrations, and spontaneous preterm birth. Am J Obstet Gynecol 217:369.e1-369.e9
Chen, Teresa K; Appel, Lawrence J; Grams, Morgan E et al. (2017) APOL1 Risk Variants and Cardiovascular Disease: Results From the AASK (African American Study of Kidney Disease and Hypertension). Arterioscler Thromb Vasc Biol 37:1765-1769
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Gibson, Kelly S; Stark, Sydney; Kumar, Deepak et al. (2017) The relationship between gestational age and the severity of neonatal abstinence syndrome. Addiction 112:711-716

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