Clinical Trials Logo

Clinical Trial Summary

Sudden cardiac death continues to be a major contributor to mortality in patients with ischemic cardiomyopathy. While implantable defibrillators can prevent death from ventricular arrhythmias, our current approach to identify patients at highest risk primarily rests on demonstrating a reduction in left ventricular ejection fraction less than 35%. The purpose of this observational cohort study is to prospectively test whether this can be enhanced by quantifying the amount of sympathetic denervation, left ventricular end-diastolic volume or brain natriuretic peptide levels.


Clinical Trial Description

Using current guidelines based primarily on ejection fraction (EF), only one-quarter of patients receiving an implantable cardiac defibrillator (ICD) for the primary prevention of sudden cardiac arrest (SCA) require appropriate ICD therapy within 5 years. The NIH-sponsored PAREPET study (Prediction of ARrhythmic Events with Positron Emission Tomography, ClinicalTrials.gov, NCT01400334) identified four independent risk factors that predict SCA or ICD equivalent in patients with ischemic cardiomyopathy. Using retrospectively defined cut-points, the absence of these risk factors identified 38% of the cohort with a very low risk of SCA (<1% per year). This rate is actually lower than the 1.5-2% annual rate of SCA among patients with coronary artery disease and mild left ventricular (LV) dysfunction, who are not considered candidates for a primary prevention ICD. This proposal will prospectively determine whether these risk factors can form the basis of a clinically applicable approach to identify a subgroup of patients who are candidates for an ICD, but are at low enough risk of SCA to have an ICD safely withheld. Our long-term goal is to develop better approaches to identify patients with coronary artery disease who are most likely to benefit from prevention of SCA with placement of an implantable defibrillator. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03493516
Study type Observational
Source State University of New York at Buffalo
Contact John M Canty, MD
Phone (716) 829-2663
Email canty@buffalo.edu
Status Recruiting
Phase
Start date April 8, 2018
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT02788656 - Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan) N/A
Completed NCT02885636 - Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial Phase 3
Terminated NCT02205411 - Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation N/A
Completed NCT02252757 - Assess Measurements of Wireless Cardiac Output Device N/A
Recruiting NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients N/A
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Withdrawn NCT00346177 - Stem Cell Study for Patients With Heart Failure Phase 2
Active, not recruiting NCT01058837 - SCD-HeFT 10 Year Follow-up N/A
Completed NCT00957541 - Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device Phase 2
Recruiting NCT01099982 - Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease N/A
Completed NCT03014375 - Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites Phase 1
Not yet recruiting NCT00716885 - The Effect of Left Ventricular Filling Pressure on Pulmonary Clearance of Free Radical Loaded White Blood Cells and Platelets in Congestive Heart Failure Patients Before and After Biventricular Pacing N/A
Completed NCT01857999 - Losartan in Decompensated Heart Failure Phase 4
Completed NCT00644410 - Autologous Mesenchymal Stromal Cell Therapy in Heart Failure Phase 1/Phase 2
Active, not recruiting NCT00526253 - To Assess Safety and Efficacy of Myoblast Implantation Into Myocardium Post Myocardial Infarction Phase 2/Phase 3
Completed NCT00344903 - Dallas Heart Study 2: Return Clinic Visit for the Dallas Heart Study Cohort N/A
Terminated NCT00338455 - Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC Phase 2
Recruiting NCT00560339 - Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients? N/A
Active, not recruiting NCT00351390 - Use of NT-proBNP Testing to Guide Heart Failure Therapy in the Outpatient Setting. N/A
Completed NCT00752596 - Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient Phase 2