A Healthy Heart is ESSENTIAL

It has become common knowledge that congestive heart failure is among the top leading causes of mortality in the United States. Over the past decade significant progress has been made in the treatment of heart failure patients who fit the New York Heart Association (NYHA) functional class I-III. Benefit has been shown from the use of angiotensin-converting enzyme inhibitors (ACEIs) and Beta-blocker agents. However, patients diagnosed with decompensated heart failure are not suited for treatment with beta-blocker therapy. For this patient population the treatment is confined to frequent inpatient hospitalizations or outpatient intravenous inotropic agent administrations. Both treatment options are expensive and taxing for patients and their families. CRSTI staff is excited about a new heart failure trial called ESSENTIAL. It is a multicenter study of oral ennoximone in advanced chronic heart failure patients sponsored by Myogen, Inc. This trial will be placebo-controlled. A placebo is a dummy treatment administered to the control group in a clinical trial in order that the specific and nonspecific effects of the experimental treatment can be distinguished, i.e., the experimental treatment, enoximone in this case, must produce better results than the placebo to be considered effective. Eligible subjects who enter the trial will be randomly assigned to one of the two treatment groups: enoximone tablet (25 mg three times a day) or a placebo tablet three times a day. The tablets will look identical and the study staff will be unaware of the assigned treatments to prevent bias in the study outcomes.

The primary study objective is to determine the safety and efficacy of low-dose enoximone therapy in subjects with advanced chronic heart failure. The study results will seek to demonstrate that, compared to placebo, low-dose enoximone will decrease hospitalization rates, decrease mortality and morbidity, improve quality of life, improve symptoms of heart failure and decrease the associated costs of caring for individuals with advanced heart failure. The minimum and maximum duration of the study is expected to be 12 and 30 months respectively, with an average participation of 21 months. Approximately 700 patients may take part in this study in North and South America. We are expecting to enroll 20-30 patients locally. CRSTI is the only participating site in the Dallas area and is looking forward to this clinical trial. Two of the CRSTI physicians are directly involved in the trial. Dr. Eric J. Eichhorn is the lead investigator for all of the involved sites worldwide and Dr. J. Edward Rosenthal is the primary investigator for the Medical City Dallas site.

Oral enoximone has undergone extensive clinical investigation over the past 15 years. Overall, there have been more than 80 separate studies conducted with this drug as part of the Phase II clinical development program. More than 5,000 subjects have been enrolled in these studies. It was shown that higher doses of enoximone, administered to stable heart failure subjects, may be associated with an adverse event rate in excess of that of placebo-treated subjects. However, when administered chronically in lower doses to pre-transplant patients with advanced heart failure, enoximone appeared to be well tolerated, allowed weaning from IV inotrope therapy, and was associated with a lowering of New York Heart Association functional class, and was not associated with increase in death rate compared to a control group at lower risk for morbidity and mortality. These data suggest that enoximone may be an effective palliative treatment for advanced heart failure and we, at CRSTI, are optimistic about our contribution to this important clinical trial.

written by Natasha Magee, RN, BA

Research Staff Profile

Natasha Magee, RN, BA
Clinical Research Coordinator

Natasha is a Clinical Research Coordinator for CRSTI. Formerly Senior Research Nurse for the Clinical Trials Office (CTO) at the University of Texas Southwestern Medical Center, Natasha was involved in research studies for many different specialties including oncology, ENT, pulmonary medicine, dermatology and pediatric cardiology.

As Clinical Research Coordinator, Natasha will work closely with both physicians and patients, assuring
the studies are carried out according to the sponsor's protocol and federal regulations.

Natasha graduated from Odessa State University, Odessa, Ukraine, with a Bachelor of Art in English, minoring in linguistics. She then graduated with an Associate of Science Degree in Nursing from Southwestern Adventist University, Keene, Texas. Natasha has worked as a registered nurse in various nursing fields, concentrating most of her recent career in research.

Natasha will concentrate most of her time working on heart failure studies and is excited about expanding her cardiovascular research experience.

A QUALITY CONTROL REVIEW OF DISCREPANCY RATES IN RECORDING PATIENT DATA
Mitchell Magee, MD
Poster presentation 2002
Quality Meeting of the American College of Cardiology and the American Heart Association

Mitchell Magee, MD
Poster Presentation
January 30- February 2, 2003
39th Annual Meeting Society of Thoracic Surgeons

THORASCOPIC SYMPATHECTOMY FOR HYPERHIDROSIS: INDICATIONS AND RESULTS
Neeland Dooblah, MD
Oral Presentation
January 30- February 2, 2003
39th Annual Meeting Society of Thoracic Surgeons

FIRST YEAR CLINICAL OUTCOMES OF PATIENTS UNDERGOING BEATING HEART CORONARY ARTERY BYPASS GRAFTING WITH PROXIMAL ANASTOMOSES PERFORMED WITH MECHANICAL CONNECTORS
Todd Dewey, MD & Mitchell Magee, MD
Poster Presentation
January 30- February 2, 2003
39th Annual Meeting Society of Thoracic Surgeons

NEW TECHNIQUES IN CORONARY ARTERY BYPASS
Tea Acuff, MD
February 1, 2003
Cardiology Update 2003; El Paso, TX

SURGICAL APPROACHES TO CHF
Tea Acuff, MD
February 1, 2003
Cardiology Update 2003, El Paso, TX

ON PUMP BEATING HEART SURGERY AS THE PROCEDURE OF CHOICE FOR UNSTABLE PATIENTS UNDERGOING CORONARY ARTERY BYPASS GRAFTING (CABG)
James Edgerton, MD
Oral Presentation
June 18-21, 2003
6th Annual International Society for Minimally Invasive Cardiac Surgery

DOES CORONARY ARTERY BYPASS IMPROVE SURVIVAL IN PATIENTS WITH END STAGE RENAL DISEASE (ESRD)?
Todd Dewey, MD
Poster Presentation
June 18-21, 2003
6th Annual International Society for Minimally Invasive Cardiac Surgery

AVOIDANCE OF CARDIOPULMONARY BYPASS IMPROVES EARLY SURVIVAL IN MULTI-VESSEL CORONARY ARTERY BYPASS PATIENTS WITH POOR VENTRICULAR FUNCTION
Todd Dewey, MD
Oral Presentation
June 18-21, 2003
6th Annual International Society for Minimally Invasive Cardiac Surgery

Pending

NEGATIVE ADENOSINE MYOCARDIAL CONTRAST ECHOCARDIOGRAMS ARE ASSOCIATED WITH EXCELLENT PROGNOSIS
Jorge Cheirif, MD
June 11-14, 2003
American Society of Echocardiography

DOES ELECTRICAL CARDIOVERSION OF ATRIAL FIBRILLATION AND ATRIAL FLUTTER RESULT IN ACUTE NORMALIZATION OF LEFT ATRIAL PRESSURE?
Jorge Cheirif, MD
June 11-14, 2003
American Society of Echocardiography

DO NUCLEAR CARDIOLOGISTS NEED A LEARNING CURVE TO INTERPRET MYOCARDIAL PERFUSION IMAGES OBTAINED BY CONTRAST ECHOCARDIOGRAPHY?
Jorge Cheirif, MD
June 11-14, 2003
American Society of Echocardiography

A PROSPECTIVE RANDOMIZED STUDY OF SAPHENOUS VEIN GRAFT PATENCY AND OUTCOMES USING MECHANICAL CONNECTORS VS SUTURING FOR PROXIMAL ANASTOMOSES IN BEATING HEART CORONARY ARTERY BYPASS GRAFTING (CABG)
Todd Dewey, MD
June 18-21, 2003
29th Annual Meetings of the Western Thoracic Surgical Association

THE EFFECT OF PREOPERATIVE CLOPIDOGREL EXPOSURE ON CORONARY ARTERY BYPASS GRAFTING OUTCOMES
Neelan Doolabh, MD
June 18-21, 2003
29th Annual Meetings of the Western Thoracic Surgical Association

REDUCED LENGTH OF STAY AND INCIDENCE OF POSTOPERATIVE INFECTION IN PATIENTS UNDERGOING THE ROSS PROCEDURE
Will Ryan, MD
June 28-July 1, 2003
2nd Biennial Meeting of Society for Heart Valve Disease

AN EIGHT YEAR EXPERIENCE WITH THE ROSS PROCEDURE
Will Ryan, MD
June 28-July 1, 2003
2nd Biennial Meeting of Society for Heart Valve Disease

CRSTI Research Protocols

CRSTI currently maintains several protocols with active enrollment. CLICK HERE for a description of current protocols, including sponsors, investigators and designated sites.