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Status:

COMPLETED

Renal Denervation for Management of Drug-Resistant Hypertension

Lead Sponsor:

KU Leuven

Conditions:

Hypertension

Eligibility:

All Genders

20-69 years

Phase:

NA

Brief Summary

INSPiRED is a multicenter parallel-group trial comparing usual medical treatment (control group) or usual medical treatment plus renal denervation (intervention). In both groups adherence will be moni...

Detailed Description

Objectives: To compare the blood pressure lowering efficacy and safety of renal denervation vs. usual medical therapy. The primary endpoints for efficacy and safety are the baseline-adjusted between-...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Women and men are eligible. Women of reproductive age should apply effective contraception.
  • Age ranges from 20 years (inclusive) to less than 70 years.
  • Patients should have essential hypertension.
  • Treatment-resistant hypertension in patients taking a stable drug regimen for at least 4 weeks consisting of 3 or more antihypertensive medications from different classes, including a diuretic.
  • Under maximal therapy, office blood pressure should be ≥140/90 mmHg and the 24-h ambulatory blood pressure should be 130 mm Hg systolic or 80 mm Hg diastolic or higher.
  • eGFR must be ≥ 60 mL/min/1.73 m2.
  • The patients should accept to have adherence checked before randomisation and during supervised follow-up, but both patients and doctors will remain blinded to the results;
  • Informed written consent.
  • Exclusion criteria:
  • Suboptimal clinical context, because of recent history or concurrent disease.
  • Isolated systolic and diastolic hypertension.
  • Body-mass index ≥ 40kg/m2.
  • The anatomy of the renal arteries is suboptimal for renal denervation.
  • Pregnancy.
  • Alcohol or substance abuse or psychiatric illnesses.
  • Participation in other study.
  • The clinical context is suboptimal for renal denervation.

Exclusion

    Key Trial Info

    Start Date :

    April 1 2014

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 31 2017

    Estimated Enrollment :

    17 Patients enrolled

    Trial Details

    Trial ID

    NCT01505010

    Start Date

    April 1 2014

    End Date

    March 31 2017

    Last Update

    March 27 2020

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Cliniques Universitaires Saint-Luc

    Brussels, Belgium, BE-1200

    2

    Universitair Ziekenhuis Gasthuisberg

    Leuven, Belgium, BE-3000