George L Bakris1, Raymond R Townsend2, Minglei Liu3, Sidney A Cohen4, Ralph D'Agostino5, John M Flack6, David E Kandzari7, Barry T Katzen8, Martin B Leon9, Laura Mauri10, Manuela Negoita3, William W O'Neill11, Suzanne Oparil12, Krishna Rocha-Singh13, Deepak L Bhatt14. 1. ASH Comprehensive Hypertension Center, University of Chicago Medicine, Chicago, Illinois. Electronic address: gbakris@medicine.bsd.uchicago.edu. 2. School of Medicine, Renal Electrolyte Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 3. Medtronic CardioVascular, Santa Rosa, California. 4. School of Medicine, Renal Electrolyte Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Medtronic CardioVascular, Santa Rosa, California. 5. Department of Medicine, Division of Cardiology, Harvard Clinical Research Institute and Boston University School of Public Health, Boston, Massachusetts. 6. Department of Medicine, Wayne State University and Detroit Medical Center, Detroit, Michigan. 7. Department of Medicine, Division of Cardiology, Piedmont Heart Institute, Atlanta, Georgia. 8. Department of Medicine, Division of Cardiology, Baptist Cardiac and Vascular Institute, Miami, Florida. 9. Department of Medicine, Division of Cardiology, New York Presbyterian Hospital, Columbia University Medical Center, and Cardiovascular Research Foundation, New York, New York. 10. Department of Medicine, Division of Cardiology, Harvard Clinical Research Institute, Brigham and Women's Hospital Heart and Vascular Center, and Harvard Medical School, Boston, Massachusetts. 11. Department of Medicine, Division of Cardiology, Henry Ford Hospital, Detroit, Michigan. 12. Department of Medicine, Division of Cardiology, University of Alabama at Birmingham, Birmingham, Alabama. 13. Department of Medicine, Division of Cardiology, Prairie Heart Institute, Springfield, Illinois. 14. Department of Medicine, Division of Cardiology, Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.
Abstract
BACKGROUND: Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring (ABPM) to assess the efficacy of the procedure. OBJECTIVES: SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) was a prospective, blinded, randomized, sham-controlled trial. The current analysis details the effect of renal denervation or a sham procedure on ABPM measurements 6 months post-randomization. METHODS:Patients with resistant hypertension were randomized 2:1 to renal denervation or sham control. Patients were on a stable antihypertensive regimen including maximally tolerated doses of at least 3 drugs including a diuretic before randomization. The powered secondary efficacy endpoint was a change in mean 24-h ambulatory systolic blood pressure (SBP). Nondipper to dipper (nighttime blood pressure [BP] 10% to 20% lower than daytime BP) conversion was calculated at 6 months. RESULTS: The 24-h ambulatory SBP changed -6.8 ± 15.1 mm Hg in the denervation group and -4.8 ± 17.3 mm Hg in the sham group: difference of -2.0 mm Hg (95% confidence interval [CI]: -5.0 to 1.1; p = 0.98 with a 2 mm Hg superiority margin). The daytime ambulatory SBP change difference between groups was -1.1 (95% CI: -4.3 to 2.2; p = 0.52). The nocturnal ambulatory SBP change difference between groups was -3.3 (95 CI: -6.7 to 0.1; p = 0.06). The percent of nondippers converted to dippers was 21.2% in the denervation group and 15.0% in the sham group (95% CI: -3.8% to 16.2%; p = 0.30). Change in 24-h heart rate was -1.4 ± 7.4 in the denervation group and -1.3 ± 7.3 in the sham group; (95% CI: -1.5 to 1.4; p = 0.94). CONCLUSIONS: This trial did not demonstrate a benefit of renal artery denervation on reduction in ambulatory BP in either the 24-h or day and night periods compared with sham (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261).
RCT Entities:
BACKGROUND: Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring (ABPM) to assess the efficacy of the procedure. OBJECTIVES: SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) was a prospective, blinded, randomized, sham-controlled trial. The current analysis details the effect of renal denervation or a sham procedure on ABPM measurements 6 months post-randomization. METHODS:Patients with resistant hypertension were randomized 2:1 to renal denervation or sham control. Patients were on a stable antihypertensive regimen including maximally tolerated doses of at least 3 drugs including a diuretic before randomization. The powered secondary efficacy endpoint was a change in mean 24-h ambulatory systolic blood pressure (SBP). Nondipper to dipper (nighttime blood pressure [BP] 10% to 20% lower than daytime BP) conversion was calculated at 6 months. RESULTS: The 24-h ambulatory SBP changed -6.8 ± 15.1 mm Hg in the denervation group and -4.8 ± 17.3 mm Hg in the sham group: difference of -2.0 mm Hg (95% confidence interval [CI]: -5.0 to 1.1; p = 0.98 with a 2 mm Hg superiority margin). The daytime ambulatory SBP change difference between groups was -1.1 (95% CI: -4.3 to 2.2; p = 0.52). The nocturnal ambulatory SBP change difference between groups was -3.3 (95 CI: -6.7 to 0.1; p = 0.06). The percent of nondippers converted to dippers was 21.2% in the denervation group and 15.0% in the sham group (95% CI: -3.8% to 16.2%; p = 0.30). Change in 24-h heart rate was -1.4 ± 7.4 in the denervation group and -1.3 ± 7.3 in the sham group; (95% CI: -1.5 to 1.4; p = 0.94). CONCLUSIONS: This trial did not demonstrate a benefit of renal artery denervation on reduction in ambulatory BP in either the 24-h or day and night periods compared with sham (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261).
Authors: Nick A Antic; Emma Heeley; Craig S Anderson; Yuanming Luo; Jiguang Wang; Bruce Neal; Ron Grunstein; Ferran Barbe; Geraldo Lorenzi-Filho; Shaoguang Huang; Susan Redline; Nanshan Zhong; R Doug McEvoy Journal: Sleep Date: 2015-08-01 Impact factor: 5.849
Authors: T A Bley; C J François; M L Schiebler; O Wieben; N Takei; J H Brittain; A Munoz Del Rio; T M Grist; S B Reeder Journal: Eur Radiol Date: 2015-05-28 Impact factor: 5.315