Renal Denervation in Hypertension

NCT01570777 | Completed Phase 4 DMC

• 1 other identifier: P110127
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the effectiveness and costs of renal denervation in addition to standardized medical treatment compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

Conditions

Hypertension, Resistant to Conventional Therapy; Renal Denervation

Keywords

Resistant hypertension; Renal denervation; Standardized medication regimen; Endovascular; Primary hypertension; Cardiovascular diseases; Vascular diseases

Outcome Measures

Primary Outcomes (2)

• Mean diurnal systolic blood pressure assessed by ABPM

  Baseline to 6 months

• Cost-effectiveness evaluation

  1 year

Secondary Outcomes (8)

• Antihypertensive medication score

  baseline to 15 months

• Adverse events of renal denervation

  baseline to 48 months

• Detailed analysis of blood pressure

  baseline to 15 months

• Change in average 24-hour and nighttime Systolic Blood Pressure by ambulatory blood pressure monitoring

  baseline to 15 months

• Change in average 24-hour, daytime and nighttime diastolic Blood Pressure, pulse pressure and heart rate by ambulatory blood pressure monitoring

  baseline to 15 months

Study Arms (2)

Renal denervation

EXPERIMENTAL

Procedure: renal denervation and optimized medication regimen

optimized medication regimen

OTHER

optimized medication regimen

Procedure: optimized medication regimen

Interventions

renal denervation and optimized medication regimen PROCEDURE

Patients are treated with the renal denervation plus a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.

Also known as: TMAOS + DR

Renal denervation

optimized medication regimen PROCEDURE

Patients are treated with a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.

Also known as: TMAOS

optimized medication regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual is more than 18 and less than 75 years old at time of randomization
• Essential hypertension diagnosed during a complete work-up within the past 2 years
• Office blood pressure ≥140 and/or 90 mmHg despite a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, including a diuretic
• functional kidneys sizing ≥ 90 mm; eGFR ≥ 40 mL/min/1.73m² (MDRD formula)
• Suitable renal anatomy compatible with the endovascular denervation procedure
• Signed Informed consent
• Confirmed resistant hypertension defined by diurnal ambulatory blood pressure measurement ≥ 135 and/or 85 mmHg after 4 week standardized triple antihypertensive treatment

You may not qualify if:

• Patients with an estimated glomerular filtration rate (eGFR) of less than 40 mL/min/1.73 m2
• Patients with secondary hypertension
• Kaliemia ≥ 6mmol/L
• Patient with single functioning kidney
• Patient with contrast media allergy
• Patient with any implantable device incompatible with radiofrequency energy delivery
• Patient with contra-indication to the anti-hypertensive standardized medication regimen
• Patient with type 1 diabetes mellitus
• Patient with malignancy within the 5 past years
• Patient with atrial fibrillation and/or a brachial circumference of ≥ 42cm

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (1)

CIC Hopital europeen george pompidou

Paris, 75015, France

Location

Related Publications (6)

• Hamdidouche I, Gosse P, Cremer A, Lorthioir A, Delsart P, Courand PY, Denolle T, Halimi JM, Girerd X, Ormezzano O, Rossignol P, Pereira H, Azizi M; DENERHTN Investigators. Clinic Versus Ambulatory Blood Pressure in Resistant Hypertension: Impact of Antihypertensive Medication Nonadherence: A Post Hoc Analysis the DENERHTN Study. Hypertension. 2019 Nov;74(5):1096-1103. doi: 10.1161/HYPERTENSIONAHA.119.13520. Epub 2019 Sep 23.

  PMID: 31995406 DERIVED

• Courand PY, Pereira H, Del Giudice C, Gosse P, Monge M, Bobrie G, Delsart P, Mounier-Vehier C, Lantelme P, Denolle T, Dourmap C, Halimi JM, Girerd X, Rossignol P, Zannad F, Ormezzano O, Vaisse B, Herpin D, Ribstein J, Bouhanick B, Mourad JJ, Ferrari E, Chatellier G, Sapoval M, Azarine A, Azizi M; DENERHTN Investigators. Abdominal Aortic Calcifications Influences the Systemic and Renal Hemodynamic Response to Renal Denervation in the DENERHTN (Renal Denervation for Hypertension) Trial. J Am Heart Assoc. 2017 Oct 10;6(10):e007062. doi: 10.1161/JAHA.117.007062.

  PMID: 29018027 DERIVED

• Gosse P, Cremer A, Pereira H, Bobrie G, Chatellier G, Chamontin B, Courand PY, Delsart P, Denolle T, Dourmap C, Ferrari E, Girerd X, Michel Halimi J, Herpin D, Lantelme P, Monge M, Mounier-Vehier C, Mourad JJ, Ormezzano O, Ribstein J, Rossignol P, Sapoval M, Vaisse B, Zannad F, Azizi M. Twenty-Four-Hour Blood Pressure Monitoring to Predict and Assess Impact of Renal Denervation: The DENERHTN Study (Renal Denervation for Hypertension). Hypertension. 2017 Mar;69(3):494-500. doi: 10.1161/HYPERTENSIONAHA.116.08448. Epub 2017 Jan 23.

  PMID: 28115517 DERIVED

• Azizi M, Pereira H, Hamdidouche I, Gosse P, Monge M, Bobrie G, Delsart P, Mounier-Vehier C, Courand PY, Lantelme P, Denolle T, Dourmap-Collas C, Girerd X, Michel Halimi J, Zannad F, Ormezzano O, Vaisse B, Herpin D, Ribstein J, Chamontin B, Mourad JJ, Ferrari E, Plouin PF, Jullien V, Sapoval M, Chatellier G; DENERHTN Investigators. Adherence to Antihypertensive Treatment and the Blood Pressure-Lowering Effects of Renal Denervation in the Renal Denervation for Hypertension (DENERHTN) Trial. Circulation. 2016 Sep 20;134(12):847-57. doi: 10.1161/CIRCULATIONAHA.116.022922. Epub 2016 Aug 30.

  PMID: 27576780 DERIVED

• Azizi M, Sapoval M, Gosse P, Monge M, Bobrie G, Delsart P, Midulla M, Mounier-Vehier C, Courand PY, Lantelme P, Denolle T, Dourmap-Collas C, Trillaud H, Pereira H, Plouin PF, Chatellier G; 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 May 16;385(9981):1957-65. doi: 10.1016/S0140-6736(14)61942-5. Epub 2015 Jan 26.

  PMID: 25631070 DERIVED

• Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323. No abstract available.

  PMID: 25186534 DERIVED

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy; Essential Hypertension; Cardiovascular Diseases; Vascular Diseases

Condition Hierarchy (Ancestors)

Hypertension

Study Officials

• Marc SAPOVAL, PD, PhD

  departement of interventional radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 4, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 15, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

FR (1)