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Title: Rationale and design of the Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial
Authors: Jin, Yu
Jacobs, Lotte
Baelen, Marie
Thijs, Lutgarde
Renkin, Jean
Hammer, Frank
Kefer, Joelle
Petit, Thibault
Verhamme, Peter
Janssens, Stefan
Sinnaeve, Peter
Lengelé, Jean-Philippe
Persu, Alexandre
Staessen, Jan A ×
investigator-steered project on intravascular renal denervation for management of drug-resistant hypertension (INSPiRED) investigators #
Issue Date: Jun-2014
Publisher: Scandinavian University Press
Series Title: Blood Pressure vol:23 issue:3 pages:138-46
Article number: 10.3109/08037051.2014.899297
Abstract: The SYMPLICITY studies showed that renal denervation (RDN) is feasible as novel treatment for resistant hypertension. However, RDN is a costly and invasive procedure, the long-term efficacy and safety of which has not yet been proven. Therefore, we designed the INSPiRED trial to compare the blood pressure lowering efficacy and safety of RDN vs usual medical therapy. INSPiRED is a randomized controlled trial enrolling 240 treatment-resistant hypertensive patients at 16 expert hypertension centres in Belgium. Eligible patients, aged 20-69 years old, have a 24-h ambulatory blood pressure of 130 mmHg systolic or 80 mmHg diastolic or more, while taking at least three antihypertensive drugs. They are randomized to RDN (EnligHTN(TM), SJM system) plus usual care (intervention group) or usual care alone (control group) in a ratio of 1:1. The primary endpoints for efficacy and safety, measured after 6 months, are the baseline-adjusted between-group differences in 24h systolic blood pressure and in glomerular filtration rate as estimated by the Chronic Kidney Disease Epidemiology Collaboration equation. Follow-up will continue up to 36 months after randomization. INSPiRED is powered to demonstrate a 10-mmHg difference in systolic blood pressure between randomized groups with a two-sided p-value of 0.01 and 90% power. It will generate long-term efficacy and safety data, identify the subset of treatment-resistant hypertensive patients responsive to RDN, provide information on cost-effectiveness, and by doing so INSPiRED will inform guideline committees and health policy makers.
ISSN: 0803-7051
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Department of Cardiovascular Sciences - miscellaneous
Hypertension and Cardiovascular Epidemiology
Molecular and Vascular Biology
Cardiology
× corresponding author
# (joint) last author

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