CoChat
Sign Up
Cited by 519Blood Pressure and Hypertension StudiesRenal and Vascular PathologiesHormonal Regulation and Hypertension

Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial

Azizi, Michel, Sapoval, Marc, Gosse, Philippe, Monge, Matthieu, Bobrie, Guillaume, Delsart, Pascal, Midulla, Marco, Mounier-Véhier, Claire +8 more·2015·The Lancet
DOI 10.1016/s0140-6736(14)61942-5
Open this paper in CoChat — free account

Abstract

Background Conflicting blood pressure-lowering effects of catheter-based renal artery denervation have been reported in patients with resistant hypertension. We compared the ambulatory blood pressure-lowering efficacy and safety of radiofrequency-based renal denervation added to a standardised stepped-care antihypertensive treatment (SSAHT) with the same SSAHT alone in patients with resistant hypertension.Methods The Renal Denervation for Hypertension (DENERHTN) trial was a prospective, open-label randomised controlled trial with blinded endpoint evaluation in patients with resistant hypertension, done in 15 French tertiary care centres specialised in hypertension management. Eligible patients aged 18-75 years received indapamide 1·5 mg, ramipril 10 mg (or irbesartan 300 mg), and amlodipine 10 mg daily for 4 weeks to confirm treatment resistance by ambulatory blood pressure monitoring before randomisation. Patients were then randomly assigned (1:1) to receive either renal denervation plus an SSAHT regimen (renal denervation group) or the same SSAHT alone (control group). The randomisation sequence was generated by computer, and stratified by centres. For SSAHT, after randomisation, spironolactone 25 mg per day, bisoprolol 10 mg per day, prazosin 5 mg per day, and rilmenidine 1 mg per day were sequentially added from months two to five in both groups if home blood pressure was more than or equal to 135/85 mm Hg. The primary endpoint was the mean change in daytime systolic blood pressure from baseline to 6 months as assessed by ambulatory blood pressure monitoring. The primary endpoint was analysed blindly. The safety outcomes were the incidence of acute adverse events of the renal denervation procedure and the change in estimated glomerular filtration rate from baseline to 6 months. This trial is registered with ClinicalTrials.gov, number NCT01570777.Findings Between May 22, 2012, and Oct 14, 2013, 1416 patients were screened for eligibility, 106 of those were randomly assigned to treatment (53 patients in each group, intention-to-treat population) and 101 analysed because of patients with missing endpoints (48 in the renal denervation group, 53 in the control group, modified intention-to-treat population). The mean change in daytime ambulatory systolic blood pressure at 6 months was -15·8 mm Hg (95% CI -19·7 to -11·9) in the renal denervation group and -9·9 mm Hg (-13·6 to -6·2) in the group receiving SSAHT alone, a baseline-adjusted difference of -5·9 mm Hg (-11·3 to -0·5; p=0·0329). The number of antihypertensive drugs and drug-adherence at 6 months were similar between the two groups. Three minor renal denervation-related adverse events were noted (lumbar pain in two patients and mild groin haematoma in one patient). A mild and similar decrease in estimated glomerular filtration rate from baseline to 6 months was observed in both groups.Interpretation In patients with well defined resistant hypertension, renal denervation plus an SSAHT decreases ambulatory blood pressure more than the same SSAHT alone at 6 months. This additional blood pressure lowering effect may contribute to a reduction in cardiovascular morbidity if maintained in the long term after renal denervation.Funding French Ministry of Health.

Integrity signals

Registry

Crossref · 10.1016/s0140-6736(14)61942-5

Cites

30 of 30 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • The DENERHTN trial demonstrated a statistically significant reduction in daytime ambulatory SBP (−5.9 mm Hg; P=0.03) in patients on 3 antihypertensive drugs randomized to renal denervation versus those on 4 antihypertensive drugs.

    “In addition, the DENERHTN trial (Renal Denervation for Hypertension) recently demonstrated a statistically significant reduction in daytime ambulatory SBP (−5.9 mm Hg; P=0.03) in patients on 3 antihypertensive drugs randomized to renal denervation versus those on 4 antihypertensive drugs.406”

    From Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association (2018) · cites this paper as [406]

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Related

Authors
Azizi, M., Sapoval, M., Gosse, P., Monge, M., Bobrie, G., Delsart, P., Midulla, M., Mounier-Véhier, C., Courand, P.-Y., Lantelme, P., Denolle, T., Dourmap-Collas, C., Trillaud, H., Pereira, H., Plouin, P.-F., & Chatellier, G.
Affiliations
  • Inserm (FR)
  • Assistance Publique – Hôpitaux de Paris (FR)
  • Centre Hospitalier Universitaire de Bordeaux (FR)
  • Centre Hospitalier Universitaire de Lille (FR)
  • Hôpital de la Croix-Rousse (FR)
  • Lyon 1 Université (FR)
Corresponding author
Azizi, Michel
ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
2015-05
Volume
385
Issue
9981
Pages
1957-1965
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(14)61942-5
OpenAlex
W2161246417
Cited by
519
References
30
Citations by year
2026: 9 · 2025: 20 · 2024: 28 · 2023: 43 · 2022: 27 · 2021: 37 · 2020: 30 · 2019: 44 · 2018: 56 · 2017: 69 · 2016: 100 · 2015: 55
FWCI
67.78
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
  • HAL (submittedVersion)
Funders
  • Assistance Publique - Hôpitaux de Paris
  • Assistance publique-Hôpitaux de Paris
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Renal and Vascular Pathologies
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
Keywords
resistant hypertension, renal denervation, radiofrequency ablation, ambulatory blood pressure, spironolactone, bisoprolol, prazosin, rilmenidine, indapamide, ramipril, irbesartan, amlodipine, adverse events, estimated glomerular filtration rate
MeSH terms
Adolescent, Adult, Aged, Antihypertensive Agents, Denervation, Drug Resistance, Drug Therapy, Combination, Female, Humans, Hypertension, Male, Middle Aged, Prospective Studies, Renal Artery, Treatment Outcome, Catheter Ablation, Medication Adherence, Young Adult

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review