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
© 2011 all rights reserved to Sleep Wellness Centers of New York Design Credits: Talent Gurus