Renal Denervation in Hypertension (DENER-HTN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01570777
First received: April 2, 2012
Last updated: June 10, 2014
Last verified: June 2013

April 2, 2012
June 10, 2014
April 2012
May 2014   (final data collection date for primary outcome measure)
  • Mean diurnal systolic blood pressure assessed by ABPM [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness evaluation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01570777 on ClinicalTrials.gov Archive Site
  • Antihypertensive medication score [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Adverse events of renal denervation [ Time Frame: baseline to 48 months ] [ Designated as safety issue: Yes ]
  • Detailed analysis of blood pressure [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Change in average 24-hour and nighttime Systolic Blood Pressure by ambulatory blood pressure monitoring [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Change in average 24-hour, daytime and nighttime diastolic Blood Pressure, pulse pressure and heart rate by ambulatory blood pressure monitoring [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Change in office Systolic/diastolic Blood Pressure [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Adherence to antihypertensive Medication [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Antihypertensive medication score [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Adverse events of renal denervation [ Time Frame: baseline to 15 months ] [ Designated as safety issue: Yes ]
  • Detailed analysis of blood pressure [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Change in average 24-hour and nighttime Systolic Blood Pressure by ambulatory blood pressure monitoring [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Change in average 24-hour, daytime and nighttime diastolic Blood Pressure, pulse pressure and heart rate by ambulatory blood pressure monitoring [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Change in office Systolic/diastolic Blood Pressure [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
  • Adherence to antihypertensive Medication [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Renal Denervation in Hypertension
Renal Denervation in Patients With Resistant Hypertension

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.

The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the efficacy and cost-effectiveness of renal denervation plus standardized optimal antihypertensive treatment compared to standardized optimal antihypertensive treatment alone in patients with proven resistant hypertension. Patients with essential resistant hypertension will first enter a 4-week run-in period during which they will receive a standardized triple combination therapy (diuretic+ ACE inhibitor+ CCB at maximal dose). After 4 weeks of standardized triple therapy patients will be randomized to renal denervation + optimal antihypertensive treatment compared to standardized optimal antihypertensive treatment if daytime ambulatory BP remains ≥ 135 and/or 85 mmHg. Bilateral renal denervation will be performed using the Symplicity Catheter (Medtronic ®) - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery. Study amendment: Extended follow-up of 48 months for all randomized patients.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension, Resistant to Conventional Therapy
  • Renal Denervation
  • Procedure: renal denervation and optimized medication regimen
    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.
    Other Name: TMAOS + DR
  • Procedure: optimized medication regimen
    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.
    Other Name: TMAOS
  • Experimental: Renal denervation
    Intervention: Procedure: renal denervation and optimized medication regimen
  • optimized medication regimen
    optimized medication regimen
    Intervention: Procedure: optimized medication regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
121
April 2018
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • 2 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

Exclusion Criteria:

  • 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 transient or fixed cerebral ischemia within 3 months before inclusion
  • Patient with myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion
  • 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01570777
P110127
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Marc SAPOVAL, PD, PhD departement of interventional radiology
Assistance Publique - Hôpitaux de Paris
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP