Cardiovascular Medicine

There are many clinical trials ongoing within Cardiovascular Medicine at Brigham and Women's Hospital.  Below you will find a list of current trials within the following subspecialties:

Cardiovascular Genetics
Diagnostic Catheterization/Interventional Services
General Cardiology
Heart Failure/Transplantation
Vascular Medicine
Thrombolysis In Myocardial Infarction (TIMI)

Cardiovascular Genetics

• Title:  Treatment of Preclinical Hypertrophic Cardiomyopathy (HCM) with Diltiazem
  Principal Investigator:   Carolyn Ho, MD
  Description:   Trial of diltiazem for patients who carry a gene mutation that puts them at risk for developing HCM but do not currently have any clinical signs of HCM. 
  
• Title:  Molecular Genetic Analysis of Cardiomyopathy
  Principal Investigator:   Christine Seidman, MD
  Description:   The goal of this study is to identify genes that cause inherited heart muscle conditions called cardiomyopathy. For people who have been diagnosed with cardiomyopathy or have family members with cardiomyopathy.  The following procedures may be done but are not required in all cases: brief physical exam, echocardiogram, EKG, MRI, and blood sample

Diagnostic Catheterization/Interventional Services

• Title:  The PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial 
  Principal Investigator(s):  Larry Cohn, MD; Andrew Eisenhauer, MD
• Title:  A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects with de novo Native Coronary Artery Lesions (SPIRIT IV).
  Principal Investigator:  Laura Mauri, MD
• Title:  The EVENT Registry
  Principal Investigator:  Laura Mauri, MD
• Title:  PROTECT I: A Prospective Feasibility Trial investigating the use of the IMPELLA® RECOVER® LP 2.5 System in Patients Undergoing High Risk PCI. 
  Principal Investigator:  Frederic Resnic, MD
• Title:  A Feasibility Study to Evaluate the Safety of The RENAL GUARD™ System in a Cardiac Catheterization Lab Setting. 
  Principal Investigator:  Frederic Resnic, MD
• Title:  A Randomized Trial to Compare Percutaneous Coronary Intervention Between Massachusetts Hospitals with Cardiac Surgery-On-Site and Community Hospitals Without Cardiac Surgery-On-Site (The MASS COMM Trial).
  Principal Investigator:  Frederic Resnic, MD
• Title:  A Study of the Evalve® Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge Repair Study (EVEREST II).
  Principal Investigator:  Andrew Eisenhauer, MD
• Title:  A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex Septal Closure System Versus Best Medical Therapy in Patients with a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patient Foramen Ovale - CLOSURE I Trial.
  Principal Investigator:   Galen Henderson, MD
  

General Cardiology

• Title:  The PREDICTION Trial (Prediction of Vascular and Clinical Outcomes by Intracoronary Vascular Profiling Study)
  Principal Investigator:   Peter H. Stone, MD
  Description:   The PREDICTION trial is a 500 patient multi-center study investigating the in-vivo natural history of coronary atherosclerosis in man, focusing both on changes in coronary plaque and arterial wall morphology (using IVUS) and clinical events.

Heart Failure/Transplantation

Medication Studies:

• Adenosine Receptor Blocker:  For patients who have been admitted to the hospital with decompensated heart failure and renal impairment, we are involved in a study examining the effects of an intravenous (IV) medication on heart failure signs and symptoms and kidney function.
  Investigator:  Dr. Michael Givertz
  Contact:  Susan Anello, RN (617) 732-7174
• New Drugs for Diastolic Heart Failure:  Brigham and Women's Hospital is actively involved in outpatient studies for patients with heart failure and normal ejection fraction to determine if certain oral medications can improve exercise tolerance and clinical outcomes.
  Investigators:  Dr. Akshay Desai
  Contact:  Kimberly Brooks, RN (617) 732-6237
• Anemia and Heart Failure: An outpatient study is ongoing to determine if treating anemia with biweekly injections (shots) of a new medication can improve outcomes in heart failure patients.
  Investigator: Dr. Eldrin Lewis
  Contact: Susan Anello, RN (617) 732-7174

Causes of Cardiomyopathy:   Approximately 50% of patients with a new diagnosis of cardiomyopathy or heart failure do not have a definite cause identified. Brigham and Women's Hospital is involved in a study to look at immunologic (the body attacking itself) and viral causes of heart failure.  This study includes a heart biopsy.
Investigator:  Dr. Kenneth Baughman
Contact:  Susan Anello, RN (617) 732-7174

Device Therapies:   Brigham and Women's Hospital is currently involved in studies to evaluate implantable cardiac devices.  These investigational devices record and report the function of the heart at rest and during activities, and may help doctors to manage patients at home with heart failure.
Investigator:  Dr. Lynne Stevenson
Contact:  Kimberly Brooks, RN (617) 732-6237

Mechanical Circulatory Support and Cardiac Transplant:   Studies are being done to assess the role of mechanical pumps in supporting patients with end-stage heart failure, some of whom are waiting for a heart transplant.
Investigator: Drs. Prem Shekar and Michael Givertz
Contact: Suzanne Kelly, RN (617) 732-7141

Vascular Medicine

• Title:  The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome.
  Principal Investigator:  Joshua Beckman, M.D.
  Objective: A study investigating the role of inflammation in patients with the metabolic syndrome. Subjects with the metabolic syndrome will undergo vascular function testing, hyperinsulinemic euglycemic clamp, skin biopsy, and blood testing during treatment with an anti-inflammatory medication and placebo.
• Title: Inflammation and Vascular Function In Atherosclerosis
  Principal Investigator:  Joshua A. Beckman, M.D.
  Objective: The purpose of the study is to determine whether reducing inflammation in blood vessels with Salsalate will improve their function.
• Title: Endothelial Function in Lower Extremity Bypass Grafts
  Principal Investigator:  Joshua A. Beckman, M.D.
  Objective: We seek to determine whether or not leg bypass grafts relax in response to increases in blood flow.
• Title: 11BHSD2 Inactivation in Resistant Hypertension
  Principal Investigator:  Joshua A. Beckman, M.D.
  Objective: 1. To define the antihypertensive efficacy of MRA in resistant hypertension. 2.To define the prevalence of 11BHSD2 inactivation in resistant hypertension. 3. To determine correlations of 11BHSD2 inactivation with vascular function in resistant hypertension.4. To determine whether 11BHSD2 inactivation determines the antihypertensive efficacy of MRA in resistant hypertension. 5. To determine 11BHSD2 inactivation predicts the blood pressure response to hydrochlorothiazide therapy in resistant hypertension.
• Title:  The Contribution of Inflammation and Insulin Resistance to Intermittent Claudication (Atorvastatin and Rosiglitazone to Reduce Symptoms of Claudication Trail in Peripheral Arterial Disease-ARREST-PAD)
  Principal Investigator:  Mark A. Creager, M.D.
  Objective: To test the hypothesis that inflammation and insulin resistance contributes to reduced walking distance in subjects with intermittent claudication by impairing vascular reactivity and skeletal muscle metabolic function.
• Title:  The Contribution of Inflammation to Vascular Function in Subjects with Type 2 Diabetes
  Principal Investigator:  Mark A. Creager, M.D.
  Objective: To test the hypothesis that inhibition of I[kappa] B kinase [beta] (IKKB), an inflammatory mediator, by high dose Salsalate will restore insulin-mediated endothelium-dependent vasodilation in patients with type 2 diabetes.
• Title:  The Impact of Free Fatty Acid Reduction on Vascular Function in Type 2 Diabetes Mellitus
  Principal Investigator:  Mark A. Creager, M.D.
  Objective: To test the hypothesis that reduction in release of free fatty acids from adipocytes will restore insulin-mediated endothelium-dependent vasodilation in subjects with type 2 diabetes.
• Title:  Randomized, Multinational, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients with Clustering Risk Factors   CRESCENDO - Comprehensive Rimonabant Evaluation Study of Cardiovascular Endpoints and Outcomes    
  Principal Investigator:  Mark A. Creager, M.D.
  Objective: 1.To demonstrate the efficacy of rimonabant versus placebo for reducing the risk of myocardial infarction, stroke, or cardiovascular death in patients with abdominal obesity at increased risk for such cardiovascular events. 2. To demonstrate the efficacy of rimonabant versus placebo for reducing the risk of myocardial infarction, stroke, cardiovascular death, or hospitalization for cardiovascular cause (unstable angina, transient ischemic attack, cardiac rhythm disorder, congestive heart failure, syncope, or urgent revascularization procedure) in patients with abdominal obesity at increased risk for such cardiovascular events.
• Title: Physician Alerts to Prevent DVT and Pulmonary Embolism in Hospitalized Patients (U.S. MULTICENTER ALERT
  Principal Investigator:  Samuel Z. Goldhaber, MD
  Objective:  To test a strategy of issuing or withholding human (as opposed to electronic) alerts to Attending Physicians (as opposed to House Officers) whose high risk hospitalized patients are not receiving prophylaxis against DVT, as a multicenter randomized controlled trial of 2,500 hospitalized patients.
  This study is a sequel to the Venous Thromboembolism Research Group’s NEJM 2005; 352: 969-977 publication.
• Title: Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or PE
  Principal Investigator:  Samuel Z. Goldhaber, MD
  Objective: To investigate the efficacy and safety of once daily enoxaparin (1.5 mg/kg/24h) as a “bridge” to warfarin for the outpatient treatment of acute deep venous thrombosis and/or pulmonary embolism. This dosing regimen of enoxaparin is investigational and has not been FDA approved for outpatients.
• Title: Fondaparinux as Monotherapy for DVT or PE
  Principal Investigator:  Samuel Z. Goldhaber, MD 
  Objective: To determine whether Fondaparinux as Monotherapy without warfarin is effective and safe for long-term (90 days) treatment of DVT and/or PE, thus gaining long-term data using fondaparinux.  Currently, fondaparinux is not approved for use beyond 10 days.  In patients with PE or DVT, it is not approved as monotherapy but only as a “bridge” to warfarin. 
• Title: Gastrointestinal Ulceration in Patients on Dual Antiplatelet Therapy after Percutaneous Coronary Intervention  (PillCam Study)
  Principal Investigator:  Samuel Z. Goldhaber, MD
  Objective: To determine the rate of symptomatic and asymptomatic gastrointestinal erosions and ulcerations in patients on dual antiplatelet (aspirin and clopidogrel) therapy, 90 days after percutaneous coronary intervention (PCI).  We will use noninvasive Pillcamâ endoscopy to assess gastrointestinal mucosa.  This study is a sequel to the Venous Thromboembolism Research Group’s Circulation 2006; 113: e655-e658 publication.
• Title: Electronic Alerts to Prevent Venous Thromboembolism: A Cohort Study
  Principal Investigator:  Samuel Z. Goldhaber, MD
  Objective: To evaluate the 90-day rate of symptomatic DVT and pulmonary embolism among patients identified electronically as being at high risk but not receiving venous thromboembolism prophylaxis.  The physicians for these patients will have received electronic alerts recommending prophylaxis.  This study is a sequel to the Venous Thromboembolism Research Group’s NEJM 2005; 352: 969-977 publication.  The prior NEJM study randomized patients to alerting their physicians versus not issuing alerts.  In the current cohort study, alerts are sent to all responsible physicians because we have “turned off” the randomization. 
• Title: Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events (ACTIVE)
  Principal Investigator:  Samuel Z. Goldhaber, MD
  Objective: To evaluate whether the angiotensin receptor blocker, irbesartan, is superior to placebo for irbesartan in preventing vascular events in patients with permanent atrial fibrillation.
• Title: Heparin Induced Thrombocytopenia Registry
  Principal Investigator:  Samuel Z. Goldhaber, MD
  Objective:  Explore the frequency of heparin-induced thrombocytopenia (HIT) at Brigham and Women's Hospital and assess its mortality rate.  This is a case series.
• Title: VITAE I & II
  Principal Investigator:  Samuel Z. Goldhaber, MD
  Objective: This is an epidemiologic study of the U.S. venous thromboembolism (VTE) burden.  We will determine the number of VTE events in acutely ill medical patients hospitalized across 38 states.  We will assess complications of VTE among surgical and medically ill patients to estimate the incidence of recurrent VTE, complications of chronic venous insufficiency, and chronic thromboembolic pulmonary hypertension. 
• Title: DVT Free Registry
  Principal Investigator:  Samuel Z. Goldhaber, MD
  Objective: A database consisting of 5,451 ultrasound-confirmed DVT patients from 183 U.S. institutions. The database will be analyzed to assess the following 5 topics:  medically ill hospitalized patients, cancer patients, nonorthopedic general surgery patients, orthopedic surgery patients, and long-haul travel. 

Thrombolysis In Myocardial Infarction (TIMI) Study Group

• Please find a list of TIMI clinical trials on their website http://www.timi.org/