CURRENT RESEARCH STUDIES

The UPBEAT Study: A Research Study of Exercise, Depression, and Heart Disease
The DISCOVER Study: Determinants of Improved Survival with Compromised Ventricular Ejection Response
ENDEAVOR Women's Health Study: Estrogen/Progesterone & Coronary Heart Disease
ENCORE Study: Exercise and Nutritional Interventions for Cardiovascular Health
The SMILE Study: Exercise & Depression in Adults Aged 40+
The INSPIRE Study: Investigational Study of Psychological Intervention in Recipients of Lung Transplant
INSIGHT Study: Biobehavioral Mechanisms of Blood Pressure Regulation

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Do you have heart disease? Are you interested in exercise?
UPBEAT: A Research Study of Exercise, Depression, and Heart Disease

What is UPBEAT?
UPBEAT is an NIH-funded trial comparing the benefits of medication (sertraline) and exercise for cardiovascular functioning and depressive symptoms.  The study is designed to evaluate the benefits of these treatments, relative to placebo pill control, in adults aged 35 years and older who have heart disease.  Recent evidence has suggested that depression may be associated with increased risk of cardiac events.  This investigation builds upon previous research showing that exercise is as effective as medication in treating adults with depression.

Am I eligible?
Must meet all of the following criteria:
ü      Experienced a heart attack, had coronary angioplasty, stenting, or bypass surgery, or had an abnormal cardiac catheterization
ü      Experiencing any of the following symptoms:
      ·  Sad or irritable mood
      ·  Loss of interest or pleasure
      ·  Sleep disturbance—insomnia or sleeping too much
      ·  Changes in appetite
      ·  Lack of energy
      ·  Feelings of guilt or worthlessness
      ·  Difficulty concentrating or making decisions
ü      35 years or older
ü      NOT currently taking antidepressant medication, exercising regularly, or in psychotherapy

What will I have to do?
Ø      Series of initial assessments including a general physical exam, an interview,      questionnaires, exercise test, and imaging of the arteries
Ø      Random assignment to one of three groups: supervised exercise, medication (sertraline), or placebo pill
Ø      16-week program followed by repeat of initial assessments
Ø      Brief assessments 6-months after program ends

 What are the benefits?
Ø      Medical & psychological assessments, at no cost
Ø      Exercise or medication, at no cost
Ø      Compensation for your time and travel

Which Group will I get?
You will be assigned by chance (like pulling numbers from a hat) to one of 3 groups:
Supervised Exercise Group
Participate in supervised exercise training three days a week. Training consists of walking, cycling, or using an elliptical trainer.
Medication Group
The medication group will take a daily FDA approved drug called sertraline (“Zoloft”) and visit with a psychiatrist regularly.
Placebo Control Group
The placebo pill group will take a daily pill with no active ingredient and visit with a psychiatrist regularly.

The UPBEAT Research Team:
James Blumenthal, Ph.D. (Principal Investigator), Andrew Sherwood, Ph.D., P. Murali Doraiswamy, M.D., Robert Waugh, M.D., Alan Hinderliter, M.D., Lana Watkins, Ph.D., Sharon Rogers, Ph.D., Emily York-Crowe, Ph.D., Seema Patidar, B.S.

For more information, please contact the UPBEAT staff at (919) 681-4747.

IRB# 7914

The DISCOVER Study: Determinants of Improved Survival with Compromised Ventricular Ejection Response

The DISCOVER study was designed to evaluate how a broad range of factors, from the structure and function of the heart to how patients feel about their life, might be linked to congestive heart failure (CHF) and its progression. The study is a collaboration between Duke University Medical Center and the University of North Carolina at Chapel Hill and is funded by the National Institutes of Health.

What does participation in DISCOVER involve?
Volunteers will come to Duke Medical Center for a 1-day study, which last approximately 6 hours and includes the following assessments:
· Echocardiogram, a real-time ultrasound picture of the heart [1 hour]
· Ultrasound imaging of a major artery [0.5 hour]
· Physiological responses to mental challenges [2 hours]
· Completion of psychological questionnaires [2 hours]
· Annual telephone or mail contact for up to 4 years after study completion

What are the benefits?
· $150 upon completion
· Free medical assessments
· Free echocardiogram
· Overnight accommodations and mileage reimbursement available for patients traveling a significant distance
· Help researchers gain a better understanding, in order to predict and prevent CHF

Who is eligible?
· Men or women aged 18 or older
· NYHA class II-III CHF of at least 3 months duration
· Left ventricular ejection fraction less than 40%

If you are interested in participating in DISCOVER, please consult your physician, who can help you determine if you meet the requirements for eligibility.

Patients who are pacemaker dependent, have uncontrolled hypertension, are currently pregnant, have had an MI, PTCA or CABG within 3 months of enrollment or who have abused alcohol or drugs within 12 months are not eligible for participation in the DISCOVER study.

The DISCOVER Research Team
Andrew Sherwood, Ph.D. (Principal Investigator), James Blumenthal, Ph.D., Alan Hinderliter, M.D., Christopher O'Connor, M.D., Kirkwood Adams, M.D., Lana Watkins, Ph.D., Robert Waugh, M.D., Michael Ellis, RDMS, RVT, Kristy Johnson, MPH, Miriam Chicurel.

For more information, please contact Kristy Johnson at (919) 681-2964.

ENCORE Study: Diet and Exercise in Adults with High Blood Pressure

ENCORE STUDY

DIET AND EXERCISE IN ADULTS WITH HIGH BLOOD PRESSURE 

The ENCORE Study (Exercise and Nutritional Interventions for Cardiovascular Health) is investigating the effects of the DASH diet (a diet high in low fat dairy products as well as fruits and vegetables), weight loss, and exercise in individuals with high blood pressure (BP).  This study is designed to: 1) Evaluate the DASH diet for the treatment of hypertension in a free-living environment; 2) compare the DASH diet alone and in combination with a cognitive-behavioral weight loss program including aerobic exercise; 3) examine the impact of diet and exercise on cardiac, metabolic and vascular function; and 4) examine the longer-term impact of these interventions on blood pressure, body weight, and cardiovascular function.  The principal investigators of ENCORE are Dr. James Blumenthal and Dr. Andrew Sherwood.  This study is funded by the National Heart, Lung, and Blood Institute. 

Potential participants must have pre-hypertension or stage 1 hypertension (resting BP 130-159/80-99 mm Hg), be overweight, and not be taking any blood pressure controlling medication.  Potential participants undergo 4 BP screening visits over a 3-week period to determine their eligibility for the study.  During these visits, we will measure blood pressure, weight and height, and give a brief physical examination.    Those who are eligible then undergo a series of bio-medical assessments (blood pressure monitoring, body composition testing, imaging of the heart and arteries, glucose tolerance testing, exercise stress testing) and then are randomly assigned to one of three groups: a diet and weight loss group, a diet only group, or a usual diet control group. 

All groups last for 16 weeks (4 months).  For the first 2 weeks participants receive food that is specially prepared at the Duke Clinical Research Unit (DCRU).  Following 2 weeks of “feeding,” the diet and weight loss group will meet 3 times a week for exercise, dietary counseling and behavior modification classes, and the diet only group will meet once a week for dietary counseling classes.  After the 16 week (4 month) program, participants are reassessed.  A 1-year follow-up assessment is performed to assess blood pressure, body composition, and heart function.

Benefits of being in the study include:

·         Free medical assessments

·         2 weeks of free food

·         Up to $355 reimbursement for travel and food during the study

·         Lower your blood pressure without medication 

The ENCORE research team: James A. Blumenthal, Ph.D. (Principal Investigator), Andrew Sherwood, Ph.D. (Co-Principal Investigator), Robert Waugh, M.D. (Medical Director), Alan Hinderliter, M.D. (Medical Co-Director), Pao-Hwa Lin, Ph.D., Michael Babyak, Ph.D., Lana Watkins, Ph.D., Carla Caccia, M.S., Teresa Edenfield, M.A., Mark Appelbaum, Ph.D., Linda Craighead, Ph.D., Mark Feinglos, M.D., Eugene Oddone, M.D., Julie M. James, MS, PA-C, Katie Earnhardt, B.A., Brian Beckman, B.A. 

For more information please call 919-681-2471.

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ENDEAVOR Women's Health Study: Estrogen/Progesterone & Coronary Heart Disease

The ENDEAVOR study is an examination of the acute effects of estrogen and estrogen/progesterone interventions on postmenopausal women with documented coronary heart disease (CHD) and age-matched healthy women. The study is designed to assess vascular endothelial function and its associated effects on systemic vascular resistance (SVR) at rest, during stress, and for 24-hours during normal daily activities. The study is funded by the National Institutes of Health.

What does participation in ENDEAVOR involve?
Volunteers will come to the Duke Medical Center for three visits, each lasting approximately 4 hours. Prior to each visit, volunteers are instructed to apply one of three randomly assigned hormone patches. Each patch will contain a small dose of estrogen, estrogen and progesterone, or an inactive (placebo) solution. Each visit will include:
· Ultrasound imaging of the heart and 2 major arteries
· A small blood sample to look at hormone and cholesterol levels
· Measurement of physiological responses to mental challenges
· Psychological questionnaires
· Instrumentation with an ambulatory blood pressure and heart monitor, to be worn for 24 hours at work and at home.

What are the benefits?
· Free medical assessments
· Blood pressure profile for a 24-hour period
· Lipid (cholesterol) profile
· Up to $300 for participating
· Help researchers gain a better understanding of coronary heart disease and the possible benefits of hormone replacement therapy

Who is Eligible for ENDEAVOR?
To participate, you must be a woman between the ages of 50 and 80 years who fits into one of the following categories:
· Cardiac Subjects: Women with a history of coronary artery disease, documented by a cardiac catheterization with more than 50% stenosis in at least one coronary artery
· Healthy Subjects: Women with no history of coronary artery disease

The ENDEAVOR Research Team
Andrew Sherwood, PhD (Principal Investigator), James Blumenthal, PhD, Alan Hinderliter, M.D., Kristin Newby, M.D., Michael Ellis, RDMS, RVT, Julie Bower, Ranak Trivedi, Therese Hennig, PA, Judith McFetridge, Ph.D.

For more information, please contact Julie Bower at (919) 684-3242.

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The SMILE Study: Exercise & Depression in Adults Aged 40+

The SMILE (Standard Medical Intervention and Long-term Exercise) Study was designed to investigate exercise as a treatment for depression in middle-aged and older adults. Two forms of aerobic exercise (supervised and home-based) are being compared to antidepressant medication (Zoloft, or sertraline) and pill placebo. The study is funded by the National Institute of Mental Health.

What does participation in SMILE involve?
Participants first complete a series of assessments, including a clinical interview, a physical examination, testing of memory and concentration, an exercise treadmill test, ultrasound assessment of vascular functioning, and a test of heart rate control. Eligible participants are then randomly assigned to one of four treatment groups: (1) Supervised Exercise at Duke's Center for Living; (2) Home-based Exercise; (3) Medication (Zoloft); or (4) Placebo pill ("sugar pill"). All treatments last 16 weeks and are offered free of charge. After treatment, participants repeat the assessments that they did at study entry. Participants return for a brief interview 6- and 12-months post-treatment.

What are the benefits?
· Free assessments
· Free 16-week treatment program
· $100 upon completion of study
· Help researchers gain a better understanding of the possible benefits of exercise training for people with depression

Who is Eligible for SMILE?
Eligible participants must be:
· 40 years of age or older
· not currently taking antidepressant medication (or, willing to come off medication for the study)
· not currently exercising
· willing to be randomly assigned to any of the four treatments

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The SMILE Research Team
James Blumenthal, Ph.D. (Principal Investigator), Alisha Hart, Ph.D., P. Murali Doraiswamy, M.D., Steve Herman, Ph.D., Erin Sheets, Lee M. Pierson, MS, Therese Hennig, PA, Michael Ellis, RDMS, RVT, Andrew Sherwood, Ph.D., Lana Watkins, Ph.D., Robert Waugh, M.D.

For more information, please contact Dr. Alisha Hart at (919) 681-2612.

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The INSPIRE Study: Investigational Study of Psychological Intervention in Recipients of Lung Transplant

The INSPIRE Study was designed to evaluate the benefits of a telephone-based stress management and coping skills training program in people who are awaiting a lung transplant. It is a collaborative study between Duke University Medical Center and Washington University Medical School and is funded by the National Heart, Lung, and Blood Institute.

What does participation in INSPIRE involve?
Participants first complete a baseline evaluation, including an interview with a staff member, tests of memory and concentration, and a questionnaire packet. They are then randomly assigned (by chance) to one of 2 groups: Stress Management (by phone) or Usual Care. Stress management participants receive a phone call from an INSPIRE interventionist every week for 12 weeks; the phone sessions focus on helping to reduce stress and learning new skills to better cope with lung disease and the upcoming transplant. The INSPIRE staff interventionists are all psychologists who have been trained to work with patients who have lung disease. Usual care participants continue their routine and usual treatments and do not receive the 12 telephone training sessions. Participants complete follow-up evaluations three months after the initial (baseline) evaluation, after transplant surgery, and twelve months after the initial evaluation.

Who is eligible for INSPIRE?
To participate, you must be listed for a lung transplant at either Duke University Medical Center or Washington University Medical School.

The INSPIRE Research Team
James Blumenthal, Ph.D. (Principal Investigator), Scott Palmer, M.D. (Medical Director), Priti Parekh, Ph.D., Jennifer Norten, Ph.D., Kari Merrill, Ph.D., Joel Hughes, Ph.D., Lee Bullock, and Jennifer Huffman.

For more information, please contact Priti Parekh at (919) 681-3054.
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INSIGHT – Biobehavioral Mechanisms of Blood Pressure Regulation

The INSIGHT Study is funded by the National Institutes of Health and is designed to further our understanding of individual differences in the nighttime fall, or “dip”, in blood pressure (BP).  Blunted nighttime BP dipping is associated with increased cardiovascular risk, especially in the presence of hypertension.  This research will help us gain a better of understanding of what factors contribute to high daytime and nighttime blood pressure levels and how these factors affect the heart, kidneys, and blood vessels. 

Who is eligible for INSIGHT?
• Men and women between the ages of 30 and 60 years
• Blood pressure above 130/85 and below 160/100 mm Hg
• Not presently on blood pressure medication
*Two screening visits to Duke for blood pressure measurements and a health history screening will determine eligibility.

What does participation in INSIGHT involve?
• Clinic Assessment (3-4 hours): Volunteers will come to Duke Medical Center, where they will participate in clinical assessments including an ultrasound examination of the heart and major arteries and have a blood sample taken to measure hormone, cholesterol and C-reactive protein levels. Participants will also undergo an interview to learn about sleep habits and to determine whether any sleep disorders are present.  Upon leaving, participants will be equipped with a small wristwatch device that will monitor their activity level over the next seven days.

• Blood Pressure Monitoring Sessions:  Participants will return to Duke Medical Center where they will be equipped with portable blood pressure and heart monitors. The monitors will be worn for 24 hours while participants carry out their normal routine. During this 24 hour session, activity levels will also be monitored and urine will be collected.  A total of 3 blood pressure monitoring sessions will be completed. 

What are the benefits of participation?
• Profile of blood pressure over a 24-hour period
• Results from blood work, including cholesterol and C-reactive protein
• Clinical echocardiography report
• Reimbursement of up to $500 upon completion of the study for time and travel expenditures

 The INSIGHT Research Team:
Andrew Sherwood, PhD (Principal Investigator), James Blumenthal, PhD, Alan Hinderliter, MD, Michael Babyak, PhD, William Wohlgemuth, PhD, Julie Bower, Michael Ellis, RDMS, RVT, Amy Hodges, Caitlyn Mathis, Nickolas Nahm, Jennifer Pascual, Steve Taxman, PA-C.

For more information, please call (919) 681-1863.  We may also be reached via email at INSIGHT@mc.duke.edu.