Provides methodological guidelines for designing and conducting clinical trials on the chronopharmacology and chronotherapy of hypertension medications.
These recommendations should guide future chronopharmacology trial design; leaves open clinical adoption pending higher-level evidence.
procedure, not by inaccurate arithmetic averages. (vi) ABPM should be performed with validated and calibrated devices at least hourly throughout two or more consecutive 24 h periods (48 h in total) to achieve the highest reproducibility of mean wake-time, sleep-time and 48 h BP values plus the reliable classification of dipping status. (vii) Calculation of minimum required sample size in adherence with proper statistical methods must be provided. (viii) Hypertension chronopharmacology and chronotherapy trials should preferably be randomized double-blind, randomized open-label with blinded-endpoint, or crossover in design, the latter with sufficient washout period between tested treatment-time regimens.
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Hermida et al. (2020) conducted a review in Hypertension. Chronopharmacology and chronotherapy of hypertension medications was evaluated. Guidelines for hypertension chronopharmacology trials recommend 48-hour ambulatory blood pressure monitoring and randomized double-blind or crossover designs.
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