PRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping blood pressure (BP). These conditions are associated with an increased risk of cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by the heart which directly regulate BP by causing dilation of blood vessels and by removing sodium and water from the body. NPs have a 24-hour day-night rhythm and this controls the day-night rhythm of BP as well. The NP-BP rhythm relationship is broken down in obese individuals. Obese individuals also have lower circulating NP levels. Lower circulating levels of NPs and elevated renin hormone (a part of the Renin-Angiotensin-Aldosterone System \[RAAS\]) at nighttime may contribute to the high nocturnal blood pressure in obese individuals which puts them at a higher risk of developing CV events. This current study seeks to determine the biological implications of chronopharmacology for synchronizing NP-RAAS-based blood pressure therapy with the physiological diurnal rhythms to restore the normal diurnal rhythm of blood pressure in obese individuals.

Eligibility criteria

Qualifiers

Age more than or equal to 18 years of age

Body Mass Index between 30 to 45 kg/m²

Blood pressure: Systolic BP more than or equal to 130mmHg and less than or equal to 160mmHg and diastolic blood pressure more than or equal to 80mmHg and less than or equal to 100mmHg. Individuals with hypertension as per the 2017 ACC/AHA Guidelines will be eligible for enrollment

Disqualifiers

Age less than 18, at screening.

Systolic BP <130 or >160mmHg at baseline, or diastolic BP <80 or >100 mmHg at baseline

BMI <30 kg/m² or >45 kg/m²

History of pulmonary hypertension

Trial design

Treatments tested in this trial

  • Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet
  • Valsartan 80 mg Oral Tablet

Treatment groups

160 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator