Effect of Renal deNervation on Arterial Stiffness and Haemodynamics in Patients With UncontRolled hypErtension (ENSURE)

NCT02102126 | Unknown Phase 4

• 1 other identifier: ENSURE
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The ENSURE study is a multi-center, prospective, single-blind, randomized, controlled study of the effect of renal denervation on arterial stiffness and haemodynamics in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the catheter, delivering radiofrequency energy through the luminal surface of the renal artery.

Conditions

Resistant Hypertensive Patients

Keywords

Renal denervation therapy; Aortic blood pressure; Blood pressure variability; Arterial stiffness; Target organ damage; Biomarker

Outcome Measures

Primary Outcomes (1)

• Change in 24-hour ambulatory aortic and brachial blood pressure and blood pressure variability

  Composite outcomes

  Baseline to 12 months post-randomization

Secondary Outcomes (1)

• Incidence of Major Adverse Events through 1 month post-randomization

  Baseline to 1 month post-randomization

Other Outcomes (1)

• Change in asymptomatic organ damages (including electrocardiographically or echocardiographically diagnosed left ventricular hypertrophy, carotid intima-media thickness or plaque, microalbuminuria, pulse wave velocity).

  baseline to 12 months post-randomization

Study Arms (2)

Renal denervation

EXPERIMENTAL

Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications

Procedure: Renal denervation

Control group

NO INTERVENTION

Subjects are maintained on baseline anti-hypertensive medications.

Interventions

Renal denervation PROCEDURE

Renal denervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual is ≥ 18 and ≤ 80 years old at time of randomization.
• Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 2 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
• Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit

You may not qualify if:

• Individual has an estimated glomerular filtration rate (eGFR) of \< 45 mL/min/1.73 m2
• Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP \< 135 mmHg
• Individual has type 1 diabetes mellitus
• Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
• Individual has primary pulmonary hypertension.
• Individual is pregnant, nursing or planning to be pregnant.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Central Study Contacts

Yawei Xu, Professor of medicine

CONTACT

+86-21-66300588; yizshcn@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: April 2, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 2, 2014

Record last verified: 2014-03

Locations

CN (1)