Lotte Jacobs1, Alexandre Persu2,3, Qi-Fang Huang1, Jean-Philippe Lengelé2,4, Lutgarde Thijs1, Frank Hammer5, Wen-Yi Yang1, Zhen-Yu Zhang1, Jean Renkin2,3, Peter Sinnaeve6, Fang-Fei Wei1, Agnès Pasquet2, Fadl Elmula M Fadl Elmula7, Marc Carlier8, Arif Elvan9, Cora Wunder10, Sverre E Kjeldsen7, Stefan W Toennes10, Stefan Janssens11, Peter Verhamme11,12, Jan A Staessen1,13. 1. a Studies Coordinating Centre, Research Unit Hypertension and Cardiovascular Epidemiology, KU Leuven Department of Cardiovascular Sciences , University of Leuven , Leuven , Belgium. 2. b Division of Cardiology , Cliniques Universitaires Saint-Luc, Université Catholique de Louvain , Brussels , Belgium. 3. c Pole of Cardiovascular Research , Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain , Brussels , Belgium. 4. d Department of Nephrology , Grand Hôpital de Charleroi , Gilly , Belgium. 5. e Division of Radiology , Cliniques Universitaires Saint-Luc, Université Catholique de Louvain , Brussels , Belgium. 6. f Division of Cardiology , University Hospitals Leuven , Leuven , Belgium. 7. g Department of Cardiology , Oslo University Hospital Ullevål , Oslo , Norway. 8. h Department of Cardiology , Grand Hôpital de Charleroi , Gilly , Belgium. 9. i Department of Cardiology , Isala Hospital , Zwolle , The Netherlands. 10. j Department of Forensic Toxicology , Institute of Legal Medicine, University of Frankfurt , Frankfurt , Germany. 11. k Division of Cardiology, Department Internal Medicine , University Hospitals Leuven , Leuven , Belgium. 12. l Centre for Molecular and Vascular Biology, Department of Cardiovascular Sciences , University of Leuven , Leuven , Belgium. 13. m R&D Group VitaK , Maastricht University , Maastricht , The Netherlands.
Abstract
OBJECTIVE: Previous trials of catheter-based renal-artery denervation (RDN) as treatment modality in resistant hypertension (rHT) generated unconvincing results. In the Investigator-Steered Project on Intravascular Denervation for Management of Treatment-Resistant Hypertension (INSPiRED; NCT01505010), we optimized selection and management of rHT patients. METHODS: With ethical clearance to randomize 18 patients, three Belgian hypertension centers screened 29 rHT patients on treatment with ≥3 drugs, of whom 17 after optimization of treatment (age <70 years; systolic/diastolic office blood pressure (BP) ≥ 140/90 mm Hg; 24-h BP ≥130/80 mm Hg; glomerular filtration rate [eGFR] ≥ 45 mL/min/1.73 m2; body mass index <40kg/m2) were randomized and 15 were analyzed 6 months later, while medical treatment was continued (n = 9) or combined with RDN by the EnligHTN™ multi-electrode system (n = 6). RESULTS: The baseline-adjusted between-group differences amounted to 19.5/10.4 mm Hg (change in control vs. intervention group, +7.6/+2.2 vs. -11.9/-8.2 mm Hg; P = .088) for office BP, 22.4/13.1 mm Hg (+0.7/+0.3 vs. -21.7/-12.8; mm Hg; P ≤ .049) for 24-h BP, the primary efficacy endpoint, and 2.5 mL/min/1.73 m2 (+1.5 vs. -1.1 mL/min/1.73 m2; P = .86) for eGFR, the primary safety endpoint. At 6 month, ECG voltages and the number of prescribed drugs (P ≤ .036) were lower in RDN patients, but quality of life and adherence, captured by questionnaire and urine analysis were similar in both groups. Changes in BP and adherence were unrelated. No major complications occurred. CONCLUSIONS: The INSPiRED pilot suggests that RDN with the EnligHTN™ system is effective and safe and generated insights useful for the design of future RDN trials.
RCT Entities:
OBJECTIVE: Previous trials of catheter-based renal-artery denervation (RDN) as treatment modality in resistant hypertension (rHT) generated unconvincing results. In the Investigator-Steered Project on Intravascular Denervation for Management of Treatment-Resistant Hypertension (INSPiRED; NCT01505010), we optimized selection and management of rHT patients. METHODS: With ethical clearance to randomize 18 patients, three Belgian hypertension centers screened 29 rHT patients on treatment with ≥3 drugs, of whom 17 after optimization of treatment (age <70 years; systolic/diastolic office blood pressure (BP) ≥ 140/90 mm Hg; 24-h BP ≥130/80 mm Hg; glomerular filtration rate [eGFR] ≥ 45 mL/min/1.73 m2; body mass index <40kg/m2) were randomized and 15 were analyzed 6 months later, while medical treatment was continued (n = 9) or combined with RDN by the EnligHTN™ multi-electrode system (n = 6). RESULTS: The baseline-adjusted between-group differences amounted to 19.5/10.4 mm Hg (change in control vs. intervention group, +7.6/+2.2 vs. -11.9/-8.2 mm Hg; P = .088) for office BP, 22.4/13.1 mm Hg (+0.7/+0.3 vs. -21.7/-12.8; mm Hg; P ≤ .049) for 24-h BP, the primary efficacy endpoint, and 2.5 mL/min/1.73 m2 (+1.5 vs. -1.1 mL/min/1.73 m2; P = .86) for eGFR, the primary safety endpoint. At 6 month, ECG voltages and the number of prescribed drugs (P ≤ .036) were lower in RDN patients, but quality of life and adherence, captured by questionnaire and urine analysis were similar in both groups. Changes in BP and adherence were unrelated. No major complications occurred. CONCLUSIONS: The INSPiRED pilot suggests that RDN with the EnligHTN™ system is effective and safe and generated insights useful for the design of future RDN trials.
Authors: Anna Pisano; Luigi Francesco Iannone; Antonio Leo; Emilio Russo; Giuseppe Coppolino; Davide Bolignano Journal: Cochrane Database Syst Rev Date: 2021-11-22
Authors: Melvin D Lobo; Andrew S P Sharp; Vikas Kapil; Justin Davies; Mark A de Belder; Trevor Cleveland; Clare Bent; Neil Chapman; Indranil Dasgupta; Terry Levy; Anthony Mathur; Matthew Matson; Manish Saxena; Francesco P Cappuccio Journal: Heart Date: 2019-07-10 Impact factor: 5.994