Heart Research Follow-up Program
The Heart Research Follow-up Program (HRFUP) has been dedicated to designing and directing cardiovascular research studies for the purpose of advancing the science of cardiology since 1970. The advancement of medical science requires basic investigation into the mechanisms of disease, improvement in clinical diagnosis and risk stratification, and development and testing of new therapies to substantiate their safety and efficacy.
The HRFUP has been involved in the design, conduct, and analysis of local and world-wide, multicenter, clinical research studies for 30 years. The studies have ranged from small or large observational studies to Phase IV clinical trials testing specific drug or device intervention. These studies use the latest basic science, bioengineering, genetic, biostatistical, physiological, and clinical approaches to optimize the acquisition of new knowledge in order to improve the diagnostic and therapeutic foundation of clinical medicine.
Commitment to Excellence in Research
In all of the studies, the HRFUP has consistently met specified enrollment numbers by recruiting strong capable enrolling center investigators, effectively coordinated multicenter activities including maintenance of regulatory standards, maintained proper quality control of large amounts of data, used sophisticated multivariate analytic methods, published definitive reports in major journals in a timely manner following completion of each study, and assisted with data submissions as requested by the study sponsors and the FDA.
- One hallmark of the HRFUP is to statistically design cost-effective studies using sequential analysis techniques to potentially allow for early study termination.
- Another hallmark of the HRFUP is to maintain strict rules of data safety/monitoring to insure investigator and sponsor independence and data integrity to facilitate rapid product approval from the FDA.
The HRFUP has an outstanding reputation for scientific excellence. As an academic-based, full-facility research center with access to a vast array of University based services, the HRFUP can provide the highest professional standards to meet all aspects of the diverse management requirements of cardiovascular research studies of clinical cardiology.
Clinical Research Experience
The HRFUP experience has included epidemiologic, pharmacologic, and medical device research studies. The HRFUP research interests include but are not limited to cardiovascular physiology, cardiac arrhythmias, sudden death, myocardial infarction, posthospital phase of myocardial infarction, heart failure, ventricular repolarization, thrombogenic factors and pharmacoeconomics. The HRFUP has direct contact with a diverse group of investigators world-wide. The HRFUP also actively collaborates with various departments at University of Rochester (Neurology, Pulmonology, Environmental Diseases, Pediatrics, Community and Preventive Medicine) on studies involving cardiovascular research in relationship to neurologic disorders, asthma and COPD disorders, environmental exposure to air pollution and mercury.
The HRFUP has directed the following studies (* = ongoing):
- Catecholamines and Cardiovascular Dysfunction (NIH)
- Follow-up Study of Acute Coronary Heart Attacks (NIH)
- Multicenter Postcoronary Risk Stratification Program (NIH)
- Long QT Syndrome: Population, Genetic and Cardiac Studies (NIH)
- Digitalis Withdrawal Trial (Burroughs Wellcome)
- Evaluation of Electric Fields on Pacemakers (Electric Power Research Institute)
- Flecainide Postinfarction Trial (Riker Laboratories)
- Multicenter Diltiazem Postinfarction Trial (Marion Laboratories)
- Nadolol Repolarization Study (Princeton Pharmaceuticals)
- Multicenter Study of Silent Myocardial Ischemia (NIH)
- Coumadin Aspirin Reinfarction Study (DuPont Merck)
- Long QT Syndrome: Genetic Studies (NIH)
- Multicenter Automatic Defibrillator Implantation Trial (CPI/Guidant)
- Thrombogenic Factors and Recurrent Coronary Events (NIH)
- Repolarization Analysis in Diphenhydramine Overdose Patients (Warner Lambert)
- Intercity Digital Electrocardiology Alliance (Burdick)
- Repolarization Analysis in Patients Treated with Mibefradil (Hoffman LaRoche)
- Multicenter Automatic Defibrillator Implantation Trial II (Guidant/Boston Scientific)
- Multicenter Automatic Defibrillator Implantation Trial II Risk Stratification Study (NIH)
- Long QT Syndrome Implantable Defibrillator Registry (Medtronic, Boston Scientific)*
- Arrhythmogenic Right Ventricular Depolarization Study (NIH)
- Study of Ventricular Repolarization in Long QT Syndrome (NIH)
- Multicenter Automatic Defibrillator Implantation Trial Using Cardiac Resynchronization Therapy (Guidant/Boston Scientific)
- Multicenter Automatic Defibrillator Implantation Trial Using Cardiac Resynchronization Therapy Registry (Guidant/Boston Scientific)
- Multicenter Automatic Defibrillator Implantation Trial Reduce Inappropriate Therapy Study (Guidant/Boston Scientific)
- Study of the Wearable Defibrillator: In Advanced Heart Failure Patients (LifeCor)*
- RAID - Ranolazine ICD Trial (NIH)*
- Interest of IKr-related Abnormalities of ECGs to Improve Drug-safety Evaluation (NIH)
- Ranolazine in LQT3 Patients (Gilead Sciences)*
- Genetics, Mechanisms and Clinical Phenotypes of Arrhythmogenic Cardiomyopathy (NIH)*
- QT RR Dynamic Coupling in Patients with the Long QT Syndrome (NIH)*
- LQT3 Registry (Gilead Sciences)*
- Multicenter Automatic Defibrillator Implantation Trial: Chemotherapy-Induced Cardiomyopathy (MADIT-CHIC)*
- Risk-Stratification of Patients with the Long QT Syndrome (LQTS) based on Holter Recordings (NIH)*
- A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging, Parallel Group Study to Evaluate the Effect of GS-6615 on Ventricular Arrhythmia in Subjects with Implantable Cardioverter-Defibrillator (ICD) or Cardiac ResynchronizationTherapy-Defibrillator (CRT-D) (Gilead Sciences)*
- A Phase 2, Proof of Concept, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination on Atrial Fibrillation Burden in Subjects with Paroxysmal Atrial Fibrillation (Gilead Sciences)*
- An Open-label Study to Evaluate the Effect of Single Dose GS-6615 on QT, Safety and Tolerability in Subjects with Long QT-3 Syndrome (Gilead Sciences).
ECG Core Lab and Electrocardiographic Research
The HRFUP has also been involved in electrophysiolgic research for over 20 years. The main focus of this research is on ventricular arrhythmias, electrocardiology in relationship to diagnosis and prognosis of entities predisposing to ventricular arrhythmias and sudden death. The ECG Core Lab has serviced numerous clinical studies and trials in adjudicating ECG, Holter, or implantable defibrillator device interrogation recordings. Numerous research projects have stemmed from this activity over the years. Our ECG Core Lab established standard adopted now world-wide for high-resolution Holter recordings in clinical studies.
Our collaboration with Electrical Engineering Department and training fellows in the field of bioengineering resulted in the advancement of ECG signal processing focused on QT measurements, ST segment monitoring, T wave alternans, T wave variability, and recently on T wave morphology. These advances together with our history of clinical research in the field of electrocardiology led to establishing the Center for Quantitative Electrocardiology and Cardiac Safety.
Center for Quantitative Electrocardiology and Cardiac Safety
- The Center operates on a tri-party collaboration between the National Health Institute (NHLBI/NIH), the Food and Drug Administration (FDA), and the University of Rochester (UR); it hosts the Telemetric and Holter ECG Warehouse (THEW), an International repository providing access to continuous electrocardiographic data to for-profit and not-for-profit organizations. This Center strives to 1) develop specific projects to implement and grow the repository of ECG information; 2) facilitate scientific projects toward the development, testing and validation of ECG-related technologies; 3) leverage expertise and resources toward the implementation of collaborative projects among the FDA, UR, and other public and private stakeholders; 4) identify, develop and evaluate new electrocardiographic markers of cardiovascular risk related to management of patient care and evaluation of new molecular entities; and 5) incorporate scientific findings into the premarket evaluation process for electrocardiographic devices and associated methodologies, and into the total product life cycle. The Telemetric and Holter ECG warehouse has initiated collaborative projects with major international corporations such as Pfizer, Roche, Philips Health care, Samsung Electronics, Medtronic, and GE Healthcare.
- Most recent work led to the development of novel technologies for contactless monitoring of patients (Xerox Corp.) and the development of the next generation of in-silico drug safety tests (IBM)
Training the next generation of investigators is an important component of our research activities. Each year cardiology fellows, residents, and students work in HRFUP to obtain experience and training in translational clinical cardiac research.
Wojciech Zareba, M.D., Ph.D. - Director of the HRFUP and Professor of Medicine and Professor of Environmental Medicine who has been Principal Investigator of several clinical cardiology studies focused on ventricular arrhythmias and sudden death and studies advancing filed of electrocardiology. Dr. Zareba also oversees clinical research in the UR Cardiology Division as Director of Cardiology Clinical Research.
Arthur J. Moss, M.D. – Former Director and Founder of the HRFUP and Professor of Medicine who has been Principal Investigator of numerous pivotal clinical studies and trial in clinical cardiology. Studies conducted by Dr. Moss led to new indications for implantable cardioverter-defibrillators exercised in thousands of patients worldwide.
Jean-Philippe Couderc, Ph.D., MBA – Director of ECG Core Lab, Assistant Director of the HRFUP, and Associate Professor of Medicine (Cardiology), Research Associate Professor of Electrical and Computer Engineering (UR College) is biomedical engineer with extensive experience in ECG signal processing. He has patented and licensed multiple technologies developed at UR. Dr, Couderc is the scientific founder of local startup company and the Director of the Center for Quantitative Electrocardiography and Cardiac Safety.
Valentina Kutyifa, M.D., Ph.D. – Research Assistant Professor of Medicine. She is an expert in the field of Cardiac Resynchronization Therapy and Heart Failure Clinical Trials with extensive clinical experience and she has numerous research collaborations in the U.S., Canada, Israel and Europe.
Scott McNitt, MS – Chief Biostatistician for the HRFUP, expert statistician overseeing all analytic activities of our organization for numerous clinical studies and trials.
Mary Brown, M.S. – Program Manager of the HRFUP, who coordinates the administrative activities and data management. Mrs. Brown has excellent expertise in methodology and conduct of clinical trials – she has been serving as main study coordinator for numerous studies and trials.
Scientific output of HRFUP 2009-2014
The vast array of activities promotes scientific growth not only measured by research grant listed above but also measured by publications. According to Web of Science as of September 15, HRFUP published 304 original papers in the last 5 years.
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