Renal Denervation for Hypertension - DENERHTN

Sep 30, 2016
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Assistance Publique-Hopitaux de Paris, French Ministry of Health
Date Published:
09/20/2016
Date Updated:
09/30/2016
Original Posted Date:
06/01/2015
References

Contribution To Literature:

The DENERHTN trial suggested that renal denervation plus standardized antihypertensive treatment might improve ambulatory blood pressure at 6 months.

Description:

The goal of the trial was to evaluate treatment with renal denervation plus standardized antihypertensive treatment versus standardized antihypertensive treatment alone.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients with resistant hypertension were randomized to renal denervation plus standardized stepped-care antihypertensive treatment (n = 53) versus standardized stepped-care antihypertensive treatment alone (n = 53).

Standardized stepped-care antihypertensive treatment consisted of spironolactone 25 mg, bisoprolol 10 mg, prazosin 5 mg, and rilmenidine 1 mg daily from months 2-5 if blood pressure was ≥135/85 mm Hg.

Inclusion criteria:

  • Patients 18-75 years of age with resistant hypertension
  • Eligible patients received indapamide 1.5 mg, ramipril 10 mg, and amlodipine 10 mg daily for 4 weeks to confirm treatment resistance

Exclusion criteria:

  • Secondary hypertension
  • Estimated glomerular filtration rate <40 cc/min/1.73 m2
  • Total number of enrollees: 106
  • Duration of follow-up: 6 months
  • Mean patient age: 55 years
  • Percentage female: 36%
  • Percentage diabetics: 17%

Principal Findings:

The primary outcome, change in systolic blood pressure from baseline to 6 months, was -15.8 mm Hg in the renal denervation group versus -9.9 mm Hg in the standardized antihypertensive treatment alone group (p = 0.033).

The proportion of patients that reached the last step of the treatment algorithm was 27.1% of the renal denervation group versus 28.3% of the standardized antihypertensive treatment alone group (p = 0.89).

Patients fully adherent to antihypertensive treatment: (20/40 vs. 21/45), partially nonadherent (13/40 vs. 20/45), or completely nonadherent (7/40 vs. 4/45); respectively, for renal denervation versus control groups (p = 0.36).

Interpretation:

Among patients with resistant hypertension, renal denervation plus standardized antihypertensive treatment was more effective at reducing ambulatory, but not office blood pressure, compared with standardized antihypertensive treatment alone. The number of antihypertensive drugs was similar between the groups at 6 months. The prevalence of antihypertensive nonadherence was high, but not different between the treatment groups. The effect on ambulatory blood pressure was small and the lack of effect on office blood pressure is perplexing. Limitations of the trial include small sample size and lack of a sham control group. Further study of renal artery denervation is necessary before the procedure should be used clinically.

References:

Azizi M, Pereira H, Hamdidouche I, et al. Adherence to Antihypertensive Treatment and the Blood Pressure–Lowering Effects of Renal Denervation in the Renal Denervation for Hypertension (DENERHTN) Trial. Circulation 2016;134:847-57.

Azizi M, Sapoval M, Gosse P, et al., on behalf of the Renal Denervation for Hypertension (DENERHTN) Investigators. Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial. Lancet 2015;2015;385:1957-65.

Keywords: Algorithms, Amlodipine, Antihypertensive Agents, Bisoprolol, Blood Pressure, Blood Pressure Monitoring, Ambulatory, Denervation, Glomerular Filtration Rate, Hypertension, Indapamide, Kidney, Oxazoles, Prazosin, Primary Prevention, Ramipril, Renal Artery, Spironolactone


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