Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED)
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|ClinicalTrials.gov Identifier: NCT01505010|
Recruitment Status : Unknown
Verified February 2015 by Jan A. Staessen, KU Leuven.
Recruitment status was: Recruiting
First Posted : January 6, 2012
Last Update Posted : February 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Procedure: Renal denervation||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
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
- Decrease in systolic blood pressure on ambulatory measurement [ Time Frame: The primary endpoint will be assessed at 6 months. ]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 ]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.
- Proportion of patients whose 24-hour blood pressure is controlled [ Time Frame: This endpoint will be assessed at the end of follow-up . ]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 . ]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. ]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 . ]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 . ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505010
|Contact: Jan A. Staessen, MD, PhDemail@example.com|
|Contact: Alexandre Persu, MD, PhDfirstname.lastname@example.org|
|Cliniques Universitaires Saint-Luc||Recruiting|
|Brussels, Belgium, BE-1200|
|Contact: Alexandre Persu, MD, PhD email@example.com|
|Contact: Jean Renkin, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Alexandre Persu, MD, PhD|
|Sub-Investigator: Jean Renkin, MD, PhD|
|Universitair Ziekenhuis Gasthuisberg||Recruiting|
|Leuven, Belgium, BE-3000|
|Contact: Geert Maleux, MD, PhD +32-16-347766 email@example.com|
|Contact: Johan Vaninbroukx, MD, PhD +32-16-347766 firstname.lastname@example.org|
|Principal Investigator: Stefan Janssen, MD, PhD|
|Sub-Investigator: Pieter Evenepoel, MD, PhD|
|Sub-Investigator: Kathleen Claes, MD, PhD|
|Principal Investigator:||Jan A. Staessen, MD, PhD||University of Leuven|