NCT04971720RecruitingPhase 2/3

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

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

Source: ClinicalTrials.gov · Last updated 9 Apr 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2/3
Study type: Interventional
Enrollment: 160 (estimated)
First submitted: 12 Jul 2021
Start date: 18 Feb 2022
Primary completion date: 1 Jan 2027
Lead sponsor: University of Alabama at Birmingham
Diseases: Obesity, High blood pressure
NCT number: NCT04971720

What you commit to

Study type: Interventional · Phase 2/3
Planned participants: 160
From 18 Feb 2022 to the primary completion date, 1 Jan 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

History of pulmonary hypertension
Have any past or present illness of cardiovascular disease including myocardial infarction, angina, cardiac arrhythmia, diabetes, stroke, TIA, or seizure.
Participants who are taking 3 or more classes of hypertension medications on the maximum dose or with resistant hypertension
History of angioedema
Significant psychiatric illness

Lab values

Estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73 m2 (CKD-EPI equation); urine albumin creatinine ratio ≥30 mg/g
Hepatic Transaminase (AST and ALT) levels \>3x the upper limit of normal;

Age

Age less than 18, at screening.

Other

Systolic BP \<130 or \>160mmHg at baseline, or diastolic BP \<80 or \>100 mmHg at baseline
BMI \<30 kg/m\^2 or \>45 kg/m\^2
Anemia (men, Hct \< 38%; women, Hct \<36%)
Participants working night shifts or swing shifts
Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)

Who the study is looking for

Age more than or equal to 18 years of age
Body Mass Index between 30 to 45 kg/m\^2
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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of Alabama at Birmingham Coordinator of this site? Confirm its status	Birmingham	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.