Renal Denervation in Hypertension (DENER-HTN)
This study is currently recruiting participants.
Verified March 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01570777
First received: April 2, 2012
Last updated: June 4, 2012
Last verified: March 2012
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Purpose
The DENER-HTN study is a, multi-center, 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension, Resistant to Conventional Therapy Renal Denervation |
Procedure: renal denervation and optimized medication regimen Procedure: optimized medication regimen |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Renal Denervation in Patients With Resistant Hypertension |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 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
|
|
optimized medication regimen
optimized medication regimen
|
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
|
Detailed Description:
The DENER-HTN study is a, multi-center, 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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 withnin 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570777
Contacts
| Contact: Michel AZIZI, PD, PhD | 00 33 (1) 56 09 29 11 | michel.azizi@egp.aphp.fr |
| Contact: Marc SAPOVAL, PD, PhD | 00 33 (1) 56 09 37 40 | marc.sapoval2@egp.aphp.fr |
Locations
| France | |
| CIC Hopital europeen george pompidou | Recruiting |
| Paris, France, 75015 | |
| Contact: Michel AZIZI, PD, PhD 00 33 (1) 56 09 29 11 michel.azizi@egp.aphp.fr | |
| Contact: Marc SAPOVAL, PD, PhD 00 33 (1) 56 09 37 40 marc.sapoval2@egp.aphp.fr | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Marc SAPOVAL, PD, PhD | departement of interventional radiology |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01570777 History of Changes |
| Other Study ID Numbers: | P110127 |
| Study First Received: | April 2, 2012 |
| Last Updated: | June 4, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Resistant hypertension Renal denervation Standardized medication regimen Endovascular |
Primary hypertension Cardiovascular diseases Vascular diseases |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013