NCT01505010

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
3 years until next milestone

Results Posted

Study results publicly available

March 27, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

January 3, 2012

Results QC Date

May 10, 2017

Last Update Submit

March 15, 2020

Conditions

Hypertension

Keywords

Treatment-resistant hypertensionRenal denervationSympathetic nervous system

Outcome Measures

Primary Outcomes (2)

  • Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement)

    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 changes in 24-h systolic blood pressure. Because automated blood pressure monitors will be used, the assessment of the primary endpoint is blind.

    The primary endpoint has been assessed 6 months after randomization.

  • Change in Glomerular Filtration Rate

    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.

    This endpoint has been assessed 6 months after randomization.

Secondary Outcomes (1)

  • The Intensity of Medical Treatment

    This endpoint will be assessed 6 months after randomization.

Study Arms (2)

Control group

OTHER

Standard antihypertensive drug treatment

Procedure: Renal denervation

Intervention group

EXPERIMENTAL

Renal denervation plus standard antihypertensive drug treatment

Procedure: Renal denervation

Interventions

Renal denervationPROCEDURE

Renal denervation in the intervention group

Also known as: Renal denervation, using an intravascular catheter system
Control groupIntervention group

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cliniques Universitaires Saint-Luc

Brussels, BE-1200, Belgium

Location

Universitair Ziekenhuis Gasthuisberg

Leuven, BE-3000, Belgium

Location

Related Publications (2)

  • Jacobs L, Persu A, Huang QF, Lengele JP, Thijs L, Hammer F, Yang WY, Zhang ZY, Renkin J, Sinnaeve P, Wei FF, Pasquet A, Fadl Elmula FEM, Carlier M, Elvan A, Wunder C, Kjeldsen SE, Toennes SW, Janssens S, Verhamme P, Staessen JA; European Network Coordinating Research on Renal Denervation. Results of a randomized controlled pilot trial of intravascular renal denervation for management of treatment-resistant hypertension. Blood Press. 2017 Dec;26(6):321-331. doi: 10.1080/08037051.2017.1320939. Epub 2017 May 10.

    PMID: 28489464RESULT

  • Jin Y, Jacobs L, Baelen M, Thijs L, Renkin J, Hammer F, Kefer J, Petit T, Verhamme P, Janssens S, Sinnaeve P, Lengele JP, Persu A, Staessen JA; investigator-steered project on intravascular renal denervation for management of drug-resistant hypertension (INSPiRED) investigators. Rationale and design of the Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial. Blood Press. 2014 Jun;23(3):138-46. doi: 10.3109/08037051.2014.899297. Epub 2014 Apr 17.

    PMID: 24742341DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Limitations and Caveats

Ethical approval was obtained to randomise 18 patients in a pilot trial, published recently (http://dx.doi.org/10.1080/08037051.2017.1320939)

Results Point of Contact

Title
Dr. Jan A. Staessen
Organization
University of Leuven
jan.staessen@med.kuleuven.be
+32 16 34 7104

Study Officials

  • Jan A. Staessen, MD, PhD

    University of Leuven

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel group trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 3, 2012

First Posted

January 6, 2012

Study Start

April 1, 2014

Primary Completion

December 31, 2016

Study Completion

March 31, 2017

Last Updated

March 27, 2020

Results First Posted

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Anonymized data can be made available via a motivated data transfer request (for scientific purposes only) via the PI (Prof Jan A. Staessen) and pending ethics approval.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Currently available until 2025
Access Criteria
Ethics approval

Locations

BE(2)