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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01505010 |
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Date of registration:
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03/01/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Renal Denervation for Management of Drug-Resistant Hypertension
INSPiRED |
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Scientific title:
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Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01505010 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Switzerland
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Contacts
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Name:
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Jan A. Staessen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Leuven |
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
69 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Procedure: Renal denervation
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Primary Outcome(s)
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Change in Glomerular Filtration Rate
[Time Frame: This endpoint has been assessed 6 months after randomization.]
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Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement)
[Time Frame: The primary endpoint has been assessed 6 months after randomization.]
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Secondary Outcome(s)
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The Intensity of Medical Treatment
[Time Frame: This endpoint will be assessed 6 months after randomization.]
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Secondary ID(s)
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INSPiRED, version 4.0
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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