Trial record 1 of 1 for:    NCT01570777
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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
  Purpose

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.


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
Endpoint Classification: Safety/Efficacy Study
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 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 ]

Enrollment: 121
Study Start Date: April 2012
Estimated Study Completion Date: April 2018
Primary Completion Date: May 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, 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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570777

Locations
France
CIC Hopital europeen george pompidou
Paris, France, 75015
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 10, 2014
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
Coronary Vasospasm
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases

ClinicalTrials.gov processed this record on August 01, 2014