Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Katholieke Universiteit Leuven
Sponsor:
Information provided by (Responsible Party):
Jan A. Staessen, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01505010
First received: January 3, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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 monitored both before randomization and during 36 months of follow-up.


Condition Intervention Phase
Hypertension
Procedure: Renal denervation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Decrease in systolic blood pressure on ambulatory measurement [ Time Frame: The primary endpoint will be assessed at 6 months. ] [ Designated as safety issue: No ]
    The primary endpoint deals with efficacy of renal denervation with regard to controlling blood pressure on ambulatory measurement. It consists of the baseline-adjusted between-group difference in the decrease in 24-h systolic blood pressure. Because automated blood pressure monitors will be used, the assessment of the primary endpoint is blind.

  • Change in glomerular filtration rate [ Time Frame: The primary endpoint will be assessed at 6 months ] [ Designated as safety issue: Yes ]
    The primary endpoint for safety of renal denervation is the baseline-adjusted between group difference in the change of glomerular filtration rate estimated by using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.


Secondary Outcome Measures:
  • Proportion of patients whose 24-hour blood pressure is controlled [ Time Frame: This endpoint will be assessed at the end of follow-up . ] [ Designated as safety issue: No ]
    The proportion of patients reaching and maintaining blood pressure control over the whole day, defined as a 24-hour blood pressure level below 130 mm Hg systolic and 80 mm Hg diastolic.

  • Proportion of patients whose daytime blood pressure is controlled [ Time Frame: This endpoint will be assessed at the end of follow-up . ] [ Designated as safety issue: No ]
    The proportion of patients reaching and maintaining blood pressure control, defined as a daytime ambulatory blood pressure and a self-measured blood pressure below 135 mm Hg systolic and 85 mm Hg diastolic.

  • Proportion of patients whose office blood pressure is controlled [ Time Frame: This endpoint will be assessed at the end of follow-up. ] [ Designated as safety issue: No ]
    The proportion of patients reaching and maintaining blood pressure control on clinic measurement, defined as an office blood pressure below 140 mm Hg systolic and 90 mm Hg diastolic.

  • The intensity of medical treatment [ Time Frame: This endpoint will be assessed at the end of follow-up . ] [ Designated as safety issue: No ]
    The number and doses of blood-pressure lowering drugs in the 2 arms of the trial.

  • Safety [ Time Frame: This endpoint will be assessed at the end of follow-up . ] [ Designated as safety issue: Yes ]
    Acute procedural safety; chronic procedural safety: reduction of estimated glomerular filtration rate by less than 25% or new stenosis over 60% confirmed by renal arteriography angiogram at 6 months.


Estimated Enrollment: 240
Study Start Date: April 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Standard antihypertensive drug treatment
Experimental: Intervention group
Renal denervation plus standard antihypertensive drug treatment
Procedure: Renal denervation
Renal denervation in the intervention group
Other Name: Renal denervation, using an intravascular catheter system

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01505010

Contacts
Contact: Jan A. Staessen, MD, PhD +32-16-347104 jan.staessen@med.kuleuven.be
Contact: Alexandre Persu, MD, PhD +32-2-7642888 alexandre.persu@uclouvain.be

Locations
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, BE-1200
Universitair Ziekenhuis Gasthuisberg Not yet recruiting
Leuven, Belgium, BE-3000
Contact: Geert Maleux, MD, PhD    +32-16-347766    geert.maleux@uzleuven.be   
Contact: Johan Vaninbroukx, MD, PhD    +32-16-347766    johan.vaninbroukx@uzleuven.be   
Principal Investigator: Stefan Janssen, MD, PhD         
Sub-Investigator: Pieter Evenepoel, MD, PhD         
Sub-Investigator: Kathleen Claes, MD, PhD         
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Jan A. Staessen, MD, PhD University of Leuven
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jan A. Staessen, Professor of Medicine, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01505010     History of Changes
Other Study ID Numbers: INSPiRED, version 4.0
Study First Received: January 3, 2012
Last Updated: March 12, 2014
Health Authority: Belgium: Institutional Review Board

Keywords provided by Katholieke Universiteit Leuven:
Treatment-resistant hypertension
Renal denervation
Sympathetic nervous system

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014