Renal Denervation in Hypertension

Hypertension, Resistant to Conventional Therapy Clinical Trial

— DENER-HTN  

Official title:

Renal Denervation in Patients With Resistant Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570777
• Other study ID #: P110127
• Status: Completed
• Phase: Phase 4
• Start date: April 2012
• Est. completion date: May 15, 2018

Study information

• Verified date: September 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: May 15, 2018
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy
• Renal Denervation

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CIC Hopital europeen george pompidou	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean diurnal systolic blood pressure assessed by ABPM		Baseline to 6 months
Primary	Cost-effectiveness evaluation		1 year
Secondary	Antihypertensive medication score		baseline to 15 months
Secondary	Adverse events of renal denervation		baseline to 48 months
Secondary	Detailed analysis of blood pressure		baseline to 15 months
Secondary	Change in average 24-hour and nighttime Systolic Blood Pressure by ambulatory blood pressure monitoring		baseline to 15 months
Secondary	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
Secondary	Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring		baseline to 15 months
Secondary	Change in office Systolic/diastolic Blood Pressure		baseline to 15 months
Secondary	Adherence to antihypertensive Medication		baseline to 15 months