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.
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.
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.
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: email@example.com
Received 29 January, 2019
Revised 14 June, 2019
Accepted 1 July, 2019