Research and Clinical Trials

The New York Heart Research Foundation is currently undertaking several clinical trials. Studies are being conducted in Atrial Fibrillation, Hypertension, Diabetes, Coronary Artery Disease, Heart Failure, Irritable Bowel Syndrome, Crohns Disease, as well as Pacemaker and Defibrillator devices. If you are interested in participating in a clinical trial or are interested in information for any of the on-going trials please call 516-739-4982 or email us

Benefits to Participating in Clinical Trials

What is a Clinical Research Study?
Clinical research studies are medical research studies designed to answer specific questions about the safety and/or effectiveness of investigational drugs, devices, and vaccines. They may also look at new ways of using existing treatments. Carefully conducted clinical studies are the fastest and safest way to help find treatments that work.

What are the Advantages to Taking Part in a Clinical Trial?
At the heart of clinical research are individuals who, by volunteering to participate in a trial, benefit future patient care by helping researchers learn what works in medicine. Consider how participation in a clinical trial will benefit patients and others in society – both now and in the future.

Gain access to promising drugs long before these compounds are available to the community.
Receive top medical care and monitoring by an expert team of doctors a who are concerned with your specific disease and are devoted to treating.
Receive free treatment and ongoing medical care for your condition.
Enjoy the unique comfort and support that can come from being part of a group of patients living with the same condition.
Help doctors and scientists better understand, diagnose, prevent, treat, improve – and even one-day – cure your condition
Assist researchers in gaining new knowledge about your disease and new treatments that might benefit future patients and generations – such as children and grandchildren.

Currently Enrolling Clinical Trials

Title : A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP (Cantos)

Brief Summary	This trial will test the hypothesis that canakinumab treatment of patients with MI at least one month prior to study entry and elevated hsCRP will prevent recurrent cardiovascular events.
Study Sponsor	Novartis
Principal Investigator	Steven Shayani, MD
Sub-Investigator	Christina Kennedy, RPA, Brian Paimany, MD
Condition	Post Myocardial Infarction
Drug	Canakinumab

Title : RESCUE: Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Diagnostic Examinations

Brief Summary	Patients with stable angina or angina equivalent will be randomized to CCTA (Coronary CT angiography) or SPECT MPI (Nuclear Stress Test)
Study Sponsor	American College of Radiology Imaging Network
Principal Investigator	Andressa Borges, MD
Sub-Investigator	Steven Shayani, MD, Steven Zeldis, MD
Condition	Stable Angina
Drug	N/A

Title : A Study To Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-D)

Brief Summary	This study will evaluate the efficacy of repeat treatment with Rifaximin 550mg TID in subject with IBS-D who respond to initial treatment with Rifaximin 550mg TID
Study Sponsor	Salix Pharmaceuticals
Principal Investigator	David Gutman, MD
Condition	IBS-D
Drug	Rifaximin

Title : Gloria AF: Global Registry on Long-Term Oral Anitithrombotic Treatment in Patients with Atrial Fibrillation

Brief Summary	To evaluate how patient characteristics influence antithrombotic treatment choice and outcome events.
Study Sponsor	Boehringer Ingelheim
Principal Investigator	Richard H. Smith, MD
Condition	Atrial Fibrillation
Drug	N/A

Title : A Placebo-Controlled, Double-Blind, Randomzied, Multi-Center, Study to Assess the Effects of Dronedarone 400 mg BID for 12 Weeks on Atrial Fibrillation Burden in Subjects with Permanent Pacemakers Hestia (Drone)

Brief Summary	This is a placebo-controlled, double-blind, randomized, multicenter study to assess AF burden and the effects of dronedarone 400mg BID versus placebo
Study Sponsor	Sanofi-Aventis
Principal	Steven Zeldis, MD
Investigator Sub I	Steven Shayani, MD
Condition	Atrial Fibrillation
Intervention	Drug: Dronedarone

Title : A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction (PEGASUS-TIMI-54)

Brief Summary	This is an event-driven, randomized, double-blind, placebo controlled, parallel group, international, multicentre study to assess the prevention of cardiovascular events with Ticagrelor compared to placebo on a background of ASA in patients with History of MI (1-3 years ago) and additional risk factors for atherothrombosis
Study Sponsor	Astra Zeneca
Principal	Steven Shayani, , MD
Investigator Sub I	Christina Kennedy, PA-C
Condition	Myocardial Infarction
Intervention	Drug: Ticagrelor

Clinical Trials Closed to Enrollment

Title : A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b (Edoxaban) Versus Warfarin In Subjects wit Artial Fibrillation-Effective aNticoaGulation with Factor xA Next Generation in Atrial Fibrillation (ENGAGE-AF-TIMI 48)

Brief Summary	This is an event driven, Phase 3, multi-national, multi-center, randomized, double-blind, double-dummy, parallel-group study to compare DU-176b to warfarin with regard to the composite primary endpoint of stroke and SEE.
Study Sponsor	Daiichi Sankyo Pharma Development
Principal	Richard H. Smith, MD
Investigator Sub I	Steven Shayani, MD Christina Kennedy, PA-C
Condition	Atrial Fibrillation
Intervention	Drug: DU-176b (Edoxaban)

Title : RELYY-ABLE Long Term Multi-Center Extension of Dabigatran Treament in Patients with Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomized Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes

Brief Summary	This is an open-label extension study for patients who have participated in the RE-LY Trial and had been taking the medication Dabigatran
Study Sponsor	Boehringer Ingelehim Pharmaceuticals..
Principal	Richard Smith, MD
Investigator Sub I	Steven Shayani MD, Matthew Moghadam
Condition	Atrial Fibrillation
Intervention	Drug: Dabigatran

Title : A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (e- GERD)

Brief Summary	This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, RAB ER 50 mg or ESO 40 mg for the treatment of moderate to severe erosive GERD.
Study Sponsor	Eisai Medical Research Inc.
Principal	David Gutman, MD
Investigator Sub I	Steven Shayani MD, Mattew Moghadam
Condition	Gastroesophageal Reflux Disease (GERD)
Intervention	Drug: Rabeprazole sodium Drug: Esomeprazole

Title : A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation (ARISTOTLE)

Brief Summary	The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.
Study Sponsor	Bristol-Myers Squibb
Principal	Richard Smith, MD
Investigator Sub I	Steven Shayani MD, Steven Zeldis MD, Mattew Moghadam
Condition	Atrial Fibrillation Atrial Flutter
Intervention	Drug: warfarin Drug: apixaban

Title : A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease (COGENTUS)

Brief Summary	The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy.
Study Sponsor	Cogentus Pharmaceuticals
Principal	George Yiachos, MD
Investigator Sub I	Steven Shayani MD, Albert Schenone MD, David Gutman MD
Condition	Acute Coronary Syndrome Myocardial Infarction Coronary Artery Disease Percutaneous Coronary Intervention
Intervention	Drug: CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin Drug: Plavix (clopidogrel 75 mg) and aspirin

Title : Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke or Systemic Embolism in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double Blind Trial (AVERROES)

Brief Summary	The purpose of this clinical research study is to learn if apixaban is more effective than Acetylsalicylic Acid (ASA) in preventing strokes and systemic embolisms associated with subjects who have atrial fibrillation. The safety of this treatment will also be studied.
Study Sponsor	Bristol-Myers Squibb
Principal	Richard Smith, MD
Investigator Sub I	Steven Zeldis MD, Steven Shayani MD
Condition	Atrial Fibrillation
Intervention	Drug: Apixaban Drug: Acetylsalicylic Acid (ASA)

Title : A treatment investigational new drug (tIND) program of Tegaserod 6 mg bid given orally in women adult patients with irritable bowel syndrome with constipation or with chronic idiopathic constipation (IBS-C, CIC)

Brief Summary	To provide tegaserod to eligible women adult patients who did not have satisfactory improvement of their irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) symptoms with other available treatment(s) and / or patients who had satisfactory improvement of their symptoms with prior tegaserod treatment for IBS-C or CIC.
Study Sponsor	Novartis Pharmaceuticals Corporation
Principal	David Gutman, MD
Investigator Sub I	None
Condition	Irritable Bowel Syndrome With Constipation Chronic Idiopathic Constipation
Intervention	Drug: Tegaserod

Title : A 5-Year Registry Study of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

Brief Summary	The primary objective of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.
Study Sponsor	Abbott
Principal	David Gutman, MD
Investigator Sub I	None
Condition	Crohn’s Disease
Intervention	Drug: adalimumab

Title : A Prospective Multi-Center Study Comparing Cardiac Computed Tomography (CT) Using a 64-Detector Row Volumetric Computed Tomography (VCT) Scanner for the Detection of Coronary Artery Disease With Cardiac Radionuclide Imaging. PICTURE

Brief Summary	To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of CAD.
Study Sponsor	GE Healthcare
Principal	Steven Shayani, MD
Investigator Sub I	Steven Zeldis, MD
Condition	Coronary Artery Disease
Intervention	Device: 64 Channel VCT

Title : Registry on Cardiac rhythm disorders: an international, observational, prospective survey assessing the control of Atrial Fibrillation (Record AF)

Brief Summary	The purpose of this study is to collect information about the following: to see how well your AF is controlled, to compare the different choices of therapy for AF, and to see how AF responds to your treatment.
Study Sponsor	Sanofi-Aventis
Principal	Richard Smith, MD
Investigator Sub I	None
Condition	Atrial Fibrillation

Title : A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)

Brief Summary	The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.
Study Sponsor	AGI Therapeutics, Inc.
Principal	David Gutman, MD
Investigator Sub I	None
Condition	Irritable Bowel Syndrome With Diarrhea
Intervention	Drug: Rezular

Title : Registry of AT/AF Episodes in the CRM Device Population: RATE Registry

Brief Summary	The purpose of this registry is to form a collection of information from various patients across the country and to observe the progress of their treatment.
Study Sponsor	St. Jude Medical
Principal	George Juang, MD
Investigator Sub I	None
Condition	Abnormal heart rhythm

Title : TREAT: The Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry

Brief Summary	The purpose of this study is to evaluate the long-term clinical, economic and humanistic outcomes of various treatment regimens, including infliximab, in Crohn's disease in real world medical practice.
Study Sponsor	Centocor, Inc.
Principal	David Gutman, MD
Investigator Sub I	None
Condition	Crohn's Disease

Title : Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy (PEGASUS CRT)

Brief Summary	This study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.
Study Sponsor	Boston Scientific Corporation
Principal	George Juang, MD
Investigator Sub I	None
Condition	Heart Failure
Intervention	Device: Cardiac Resynchronization Therapy

Title : CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision (CONNECT)

Brief Summary	The purpose of this study is to determine whether the ability of clinicians to receive and review information from patients implanted with a heart device over the internet (remote care) is comparable to patients who are seen in-office for routine visits to check the status of their device.
Study Sponsor	Medtronic Cardiac Rhythm Disease Management
Principal	George Juang, MD
Investigator Sub I	None
Condition	Arrhythmia Tachycardia Atrial Fibrillation Ventricular Fibrillation
Intervention	Device: Remote Management Device: In-Office Care

Title : Optim Lead insulation Material (OPTIMUM) Registry

Brief Summary	The primary purpose of this registry is to produce a large database of information on patients implanted with an SJM Optim lead.
Study Sponsor	St. Jude Medical
Principal	George Juang, MD
Investigator Sub I	None
Condition	Patient Has a Standard Indication for a pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator.

Title : FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

Brief Summary	The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and inter-ventricular (V-V) delay optimization using QuickOpt in patients with CRT-D device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-IEGM optimization methods).
Study Sponsor	St. Jude Medical
Principal	George Juang, MD
Investigator Sub I	None
Condition	Patient Has a Standard Indication for a CRT-D
Intervention	Device: Optimization of atrio-ventricular (AV/PV) and inter-ventricular (V-V) delays

Title : A Multicenter, Randomized, Double Blind, Double Dummy, Parallel Group Study to Compare Effects of Coreg CR and Coreg IR on Left Ventricular End Systolic Volume Index in Subjects With Stable Chronic Heart Failure (Compare)

Brief Summary	The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in improving heart function in subjects with stable chronic heart failure.
Study Sponsor	GlaxoSmithKline
Principal	Albert Schenone, DO
Investigator Sub I	Steven Shayani, MD George Yiachos, MD Jin Park, MD Richard Smith, MD Steven Zeldis, MD Michael Gurfinkel, DO Brian Paimany, MD Steven Blumenthal, MD George Juang, MD
Condition	Congestive Heart Failure
Intervention	Drug: Omega-3-acid ethyl esters

Title : A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of Omacor for the Prevention of Recurrent, Symptomatic Atrial Fibrillation (OM8 AFib)

Brief Summary	The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.
Study Sponsor	Reliant Pharmaceuticals
Principal	Richard Smith, MD
Investigator Sub I	Steven Shayani, MD Albert Schenone, DO George Yiachos, MD Jin Park, MD Steven Zeldis, MD Michael Gurfinkel, DO Brian Paimany, MD Steven Blumenthal, MD George Juang, MD
Condition	Atrial Fibrillation
Intervention	Drug: Omega-3-acid ethyl esters

Title : A Placebo-Controlled,Double-Blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in patiENts With Atrial Fibrillation/Atrial Flutter (AF/AFL) (ATHENA)

Brief Summary	The primary efficacy parameter is the combined endpoint of cardiovascular hospitalization and death. Secondary efficacy parameters are death of any cause, cardiovascular death, cardiovascular hospitalization and non-cardiovascular hospitalization.
Study Sponsor	Sanofi-Aventis
Principal	Steven Zeldis, MD
Investigator Sub I	Steven Shayani, MD
Condition	Atrial Fibrillation Atrial Flutter
Intervention	Drug: Dronedarone

Title : A Phase III, Multicenter, Open Label, Extension Study to Evaluate the Long-Term Safety of Renzapride 4 mg Once Daily in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C) (Alizyse 052)

Brief Summary	The main purpose of this study is to evaluate the long-term safety and tolerability of Renzapride at a dose of 4 mg taken once daily for 12 months in women with constipation-predominant irritable bowel syndrome (IBS-C).
Study Sponsor	Alizyme
Principal	David Gutman, MD
Investigator Sub I	Steven Shayani, MD
Condition	Constipation-Predominant Irritable Bowel Syndrome
Intervention	Drug: Renzapride

Title : A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (c-IBS) (Alizyse 038)

Brief Summary	The purpose of the study is to investigate whether Renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome in female patients.
Study Sponsor	Alizyme
Principal	David Gutman, MD
Investigator Sub I	Steven Shayani, MD
Condition	Irritable Bowel Syndrome
Intervention	Drug: Renzapride

Title : BPSZ-BLISS: Blood Pressure Success Zone Longitudinal Observational Study of Success

Brief Summary	Outcomes data collection in Blood Pressure Success Zone program participants.
Study Sponsor	Novartis
Principal	Steven Shayani, MD
Investigator Sub I	None
Condition	Hypertension
Intervention

Title : Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)

Brief Summary	The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed AV/PV delay. This study will compare the two methods of programming with respect to intrinsic activity.
Study Sponsor	St. Jude Medical
Principal	Steven Shayani, MD
Investigator Sub I	George Juang, MD
Condition	Arrhythmia
Intervention	Device: Autointrinsic Conduction Search Algorithm

Title : Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: Prospective, Multi-Centre, parallel-group, non-inferiority trial.

Brief Summary	The primary objective of this trial is to demonstrate the efficacy and safety of Dabigatran Etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism
Study Sponsor	Boehringer Ingelheim Pharmaceuticals
Principal	Richard Smith, MD
Investigator Sub I	Steven Shayani, MD Albert Schenone, DO George Yiachos, MD Jin Park, MD Steven Zeldis, MD Michael Gurfinkel, DO Brian Paimany, MD Steven Blumenthal, MD
Condition	Atrial Fibrillation
Intervention	Drug: Dabigatran etexilate Drug: Warfarin

Title : Atrial Fibrillation: Focus on Effective Clinical treatment Strategies (AFFECTS) Registry

Brief Summary	This is an observational registry used to gather real world data.
Study Sponsor	Reliant Pharmaceuticals
Principal	Richard Smith, MD
Investigator Sub I	Steven Shayani, MD
Condition	Atrial Fibrillation

Title : Impact of a Self-Adjusted Titration Guideline in Subjects With Type 2 Diabetes Mellitus: A Treat-to-Target of the Efficacy and Safety of Levemir® (Insulin Detemir [rDNA Origin] Injection) (Predictive 303)

Brief Summary	This trial aims for a comparison of the safety and efficacy in subjects with type 2 diabetes using either self titration or physician guided titration according to the local standard of care.
Study Sponsor	Novo Nordisk, Inc.
Principal	Steven Shayani, MD
Investigator Sub I	None
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: insulin detemir