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Feasibility of 24-h central blood pressure monitoring

experience from multinational clinical trial assessing the efficacy of perindopril/indapamide/amlodipine

Topouchian, Jirara; Mourad, Jean-Jacquesb; De Champvallins, Martinec; Feldmann, Lucc; Asmar, Rolandd on behalf of the study coordinators, investigators

doi: 10.1097/HJH.0000000000002199
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Objectives: Brachial blood pressure (BP) is a predictor of cardiovascular events. Evidence suggests that central BP (CBP) provides additional information for cardiovascular risk assessment. Methods to assess 24-h CBP are now available. Our objective was to assess the feasibility of 24-h CBP monitoring in clinical trials and its ability for drug evaluation.

Methods: Data are issued from an international phase 3 randomized clinical trial comparing the efficacy of perindopril/indapamide/amlodipine vs. perindopril/indapamide (Per/Ind), in uncontrolled hypertensive patients treated with Per/Ind. 24-h ambulatory BP monitoring (ABPM) was performed at baseline and after 1-month treatment using the Mobil-O-Graph device which provide brachial BP and CBP and arterial parameters.

Results: From the 345 patients included in the ABPM substudy, 276 had two valid ABPM (M0 and M1) for brachial BP assessment (80%). After applying device/software built-in and expert quality control criteria on these recordings, 210 (76%) had valid data at M0 and M1 for the assessment of CBP. After 1 month, superior ambulatory central SBP reductions were observed in the perindopril/indapamide/amlodipine (n = 101) vs. Per/Ind group (n = 109) for 24-h/daytime/night-time periods (−4.5 mmHg, P = 0.002/−5.0, P < 0001/−4.1 mmHg, P = 0.016, respectively). Similar trends were observed for pulse wave velocity and other central parameters.

Conclusion: Recording 24-h central ABPM and its derived arterial parameters needs a strict expert quality control and must consider a loss of up to 39% of the population included in the ABPM substudy. This method can be used to assess drug effect.

aParis-Descartes University, AP-HP, Diagnosis and Therapeutic Center, Hôtel Dieu

bDepartment of Internal Medicine & ESH Excellence Centre, St Joseph Hospital, Paris

cInstitut de Recherches Internationales Servier, Suresnes, France

dFoundation-Medical Research Institutes, Geneva, Switzerland

Correspondence to Dr Jirar Topouchian, MD, Paris-Descartes University, AP-HP, Diagnosis and Therapeutic Center, Hôtel-Dieu, 1 rue de la Cité, 75181 Paris, France. Tel: +33 0 620102109; e-mail: jtopouchian@jtcrc.com

Received 29 January, 2019

Revised 14 June, 2019

Accepted 1 July, 2019

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