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Results of a randomized controlled pilot trial of intravascular renal denervation for management of treatment-resistant hypertension

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Jacobs, Lotte Persu, Alexandre [UCL] Huang, Qi-Fang Lengelé, , Jean-Philippe [UCL] Thijs, Lutgarde Hammer, Frank [UCL] Renkin, Jean [UCL] Pasquet, Agnes [UCL] European Network Coordinating Research on Renal Denervation.

(eng) 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.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès restreint
Publication date 2017
Language Anglais
Journal information "Blood Pressure" - Vol. 26, no. 6, p. 321-331 (2017)
Peer reviewed yes
Publisher Taylor & Francis ((United Kingdom) Abingdon)
issn 0803-7051
e-issn 1651-1999
Publication status Publié
Affiliations UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire
UCL - SSS/IREC/IMAG - Pôle d'imagerie médicale
UCL - (SLuc) Service de cardiologie
UCL - (SLuc) Service de radiologie
UCL - SSS/IONS/NEUR - Clinical Neuroscience
Keywords Internal Medicine ; Cardiology and Cardiovascular Medicine ; General Medicine ; Adherence ; Blood pressure monitoring ; Clinical science ; Glomerular filtration rate ; Renal denervation ; Resistant hypertension
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Bibliographic reference Jacobs, Lotte ; Persu, Alexandre ; Huang, Qi-Fang ; Lengelé, , Jean-Philippe ; Thijs, Lutgarde ; et. al. Results of a randomized controlled pilot trial of intravascular renal denervation for management of treatment-resistant hypertension. In: Blood Pressure, Vol. 26, no. 6, p. 321-331 (2017)
Permanent URL http://hdl.handle.net/2078.1/195288