title: Lifestyle modification for resistant hypertension: The TRIUMPH randomized clinical trial.
abstract: BACKGROUND
  Resistant hypertension (RH) is a growing health burden in this country affecting as many as 1 in 5 adults being treated for hypertension. Resistant hypertension is associated with increased risk of adverse cardiovascular disease (CVD) events and all-cause mortality. Strategies to reduce blood pressure (BP) in this high-risk population are a national priority.
  
  
  METHODS
  TRIUMPH is a single-site, prospective, randomized clinical trial to evaluate the efficacy of a center-based lifestyle intervention consisting of exercise training, reduced sodium and calorie Dietary Approaches to Stop Hypertension eating plan, and weight management compared to standardized education and physician advice in treating patients with RH. Patients (n = 150) will be randomized in a 2:1 ratio to receive either a 4-month supervised lifestyle intervention delivered in the setting of a cardiac rehabilitation center or to a standardized behavioral counseling session to simulate real-world medical practice. The primary end point is clinic BP; secondary end points include ambulatory BP and an array of CVD biomarkers including left ventricular hypertrophy, arterial stiffness, baroreceptor reflex sensitivity, insulin resistance, lipids, sympathetic nervous system activity, and inflammatory markers. Lifestyle habits, BP, and CVD risk factors also will be measured at 1-year follow-up.
  
  
  CONCLUSIONS
  The TRIUMPH randomized clinical trial (ClinicalTrials.gov NCT02342808) is designed to test the efficacy of an intensive, center-based lifestyle intervention compared to a standardized education and physician advice counseling session on BP and CVD biomarkers in patients with RH after 4 months of treatment and will determine whether lifestyle changes can be maintained for a year.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC. Electronic address: blume003@mc.duke.edu.
authors.forename: James A
authors.initials: JA
authors.lastname: Blumenthal
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
authors.forename: Andrew
authors.initials: A
authors.lastname: Sherwood
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Smith
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Mabe
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
authors.forename: Lana
authors.initials: L
authors.lastname: Watkins
authors.affiliation: Department of Medicine, Duke University Medical Center, Durham, NC.
authors.forename: Pao-Hwa
authors.initials: PH
authors.lastname: Lin
authors.affiliation: Department of Psychology, Emory University, Atlanta, GA.
authors.forename: Linda W
authors.initials: LW
authors.lastname: Craighead
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
authors.forename: Michael
authors.initials: M
authors.lastname: Babyak
authors.affiliation: Department of Medicine, Duke University Medical Center, Durham, NC.
authors.forename: Crystal
authors.initials: C
authors.lastname: Tyson
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
authors.forename: Kenlyn
authors.initials: K
authors.lastname: Young
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
authors.forename: Megan
authors.initials: M
authors.lastname: Ashworth
authors.affiliation: Department of Medicine, Duke University Medical Center, Durham, NC.
authors.forename: William
authors.initials: W
authors.lastname: Kraus
authors.affiliation: Department of Medicine, Duke University Medical Center, Durham, NC.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Liao
authors.affiliation: Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Alan
authors.initials: A
authors.lastname: Hinderliter
mesh_terms: D000328:Adult; D001521:Behavior Therapy / Q000379:methods*; D001794:Blood Pressure / Q000502:physiology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000503:physiopathology / Q000628:therapy*; D008019:Life Style; D008297:Male; D011446:Prospective Studies; D012307:Risk Factors; D016896:Treatment Outcome