CURRENT RESEARCH STUDIES
The DISCOVER Study: Determinants of Improved
Survival with Compromised Ventricular Ejection Response
ENDEAVOR Women's Health Study: Estrogen/Progesterone
& Coronary Heart Disease
SMART HEART: Exercise & Stress Management
in Patients with Coronary Artery Disease
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
.
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.
.
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.
.
SMART HEART: Exercise & Stress Management in Patients with Coronary
Artery Disease
SMART HEART is a collaborative study between Duke University Medical Center and the University of North Carolina Hospitals designed to: (1) examine the relationship between mental stress and coronary artery disease (CAD), and (2) evaluate the benefits of exercise training and stress management programs for patients with CAD. This investigation builds upon previous research indicating that stress-induced myocardial ischemia (temporary inadequate blood supply to the heart), which is associated with adverse health outcomes, may be improved with exercise or stress management. The Principal Investigators of Smart Heart are Dr. James Blumenthal and Dr. Andrew Sherwood. The study is funded by the National Heart, Lung, and Blood Institute.
What does participation
in SMART Heart involve?
Potential participants first have a general physical examination. Those
who appear to be eligible for the study then complete a series of initial
assessments (blood pressure/ECG monitoring, imaging of the heart and
arteries). Participants are then randomly assigned to one of three groups:
stress management, aerobic exercise, or usual care. The 16-week intervention
is followed by a repeat of the initial assessments. Participants are
contacted by telephone or mail each year for 5 years after study completion.
What are the benefits?
· Free medical assessments
· Free 16-week exercise or stress management program (for most
participants)
· $300 upon completion of study
· Improve your health
· Contribute to science
Who is eligible?
Persons who are not currently enrolled in a cardiac rehabilitation program
but have history of coronary artery disease, documented by any of the
following:
· Previous myocardial infarction (heart attack)
· Prior coronary revascularization, such as bypass surgery, balloon
angioplasty, or stent
· Previous cardiac catheterization with more than 75% stenosis
(blockage) in at least one coronary artery
· Positive exercise treadmill test or positive MUGA/Thallium
scan in last 2 years
Click below to view an advertisement for the Smart Heart Study.
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The Smart Heart Research
Team
James Blumenthal, Ph.D. (Principal
Investigator), Andrew Sherwood, Ph.D.,
Robert
Waugh, M.D., Alan Hinderliter, M.D., Edward Coleman, M.D., Simon
Bacon, Ph.D., Kathy Light, M.D., Therese Hennig, PA, Michael Ellis,
RDMS, RVT, Lee M. Pierson, MS, Margaret Stewart, and Rebecca Thurston.
For more information, please contact Margaret Stewart at (919) 684-3975.
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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
Click below to view an advertisement for the Smile Study.
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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.
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.