RecruitingPhase 2Phase 3NCT04971720

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

Natriuretic Peptide-Renin-Angiotensin-Aldosterone System Rhythm Axis and Nocturnal Blood Pressure

Sponsor

University of Alabama at Birmingham

Enrollment

160 participants

Start Date

Feb 18, 2022

Study Type

INTERVENTIONAL

Conditions

Obesity Cardiovascular Diseases Hypertension Natriuretic Peptides Nocturnal Blood Pressure Renin-Angiotensin-Aldosterone System

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking blood pressure medication at a specific time of day — timed according to your body's natural daily hormone rhythms — is more effective than standard blood pressure treatment in people with obesity-related high blood pressure. **You may be eligible if...** - You are 18 years or older - Your BMI is between 30 and 45 (indicating obesity) - Your blood pressure is elevated: systolic (top number) between 130 and 160, and diastolic (bottom number) between 80 and 100 - You meet the 2017 guidelines for a diagnosis of hypertension **You may NOT be eligible if...** - Your blood pressure is outside the required range at baseline - Your BMI is below 30 or above 45 - You have a history of heart attack, stroke, diabetes, heart rhythm problems, or seizures - You are already taking 3 or more blood pressure medications - You have pulmonary hypertension Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSacubitril-Valsartan 49 Mg-51 Mg Oral Tablet

The subject will be randomized, in a double-blind manner to sacubitril/valsartan 49/51 mg once in the morning or once in the evening for a period of 28 days.

DRUGValsartan 80 mg Oral Tablet

The subject will be randomized, in a double-blind manner to valsartan 80 mg once in the morning or once in the evening for a period of 28 days.