What they want
Conduct a patient-oriented physiological, clinical trial using a 2x2 factorial design. Participants will be randomized to one of four arms: daytime dosing of LCZ696, nighttime dosing of LCZ696, daytime dosing of valsartan, or nighttime dosing of valsartan. The study will assess the effect of timing (morning vs. evening dose) and type (LCZ696 vs. valsartan) of NP-RAAS-BP axis therapy on the nighttime blood pressure profile, NP levels, RAAS levels, and their diurnal rhythms in obese hypertensive patients with non-dipping nocturnal blood pressure.
Deliverables
- Assessment of the effect of timing of NP-RAAS-BP axis medication on nighttime BP profile
- Assessment of the effect of type of NP-RAAS-BP axis therapy on nocturnal BP profile
- Examination of the impact of timing and type of therapy on NP levels, RAAS levels, and their diurnal rhythms
Technical requirements
- 2x2 factorial design clinical trial
- Randomization to four arms: daytime LCZ696, nighttime LCZ696, daytime valsartan, nighttime valsartan
- Study population: obese hypertensive individuals with non-dipping nocturnal BP
- Measurement of NP levels, RAAS levels, and diurnal rhythms
