TRIUMPH Study for Hard-to-Control High Blood Pressure - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the effects of diet, exercise, and weight management on blood pressure and risk factors for heart disease in adults with high blood pressure that is hard to control with medicine.
What is the Condition Being Studied?
High Blood Pressure

Who Can Participate in the Study?

Adults age 35 and older who:
- Have high blood pressure and are currently taking 3 or more medicines to treat their blood pressure
- Have a BMI 25 or higher and not very physically active
- Are not currently on a special diet  
- Are willing to participate in a diet and exercise program
- Not using insulin for diabetes

For more information about who can be in this study, please contact the study team.

Age Group

What is Involved?

If you choose to join this study, you will:

- Have several screening visits to make sure it is safe for you to be in the study which include:
-- Blood pressure checks
-- Physical exam
-- An ultrasound of your heart (called an echocardiogram),
-- Blood and urine tests,
-- Treadmill exercise stress tests,
-- Measurements of your physical activity level and
-- Questionnaires about your diet, activity habits, memory, thinking and how you feel

- Be randomized (like the flip of a coin) to one of two groups:
-- A supervised diet, exercise and weight management program that includes 16 weekly visits with a dietician and weight loss specialist and supervised exercise sessions three times per week for 16 weeks.


-- A standardized education and physician advice plan in which you are encouraged to lose weight, eat per the DASH diet and exercise on your own for 16 weeks.

- Be in the study for about a year.

Study Details

Full Title
Treating Resistant Hypertension Using Lifestyle Modification to Promote Health
Principal Investigator
Clinical Psychologist
Protocol Number
IRB: PRO00055703
NCT: NCT02342808
Contact the Duke Recruitment Innovation Center