Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
NCT04971720

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

Led by University of Alabama at Birmingham · Updated on 2026-04-09

160

Participants Needed

1

Research Sites

254 weeks

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Body Mass Index between 30 to 45 kg/m^2
  • Systolic blood pressure between 130 and 160 mmHg and diastolic blood pressure between 80 and 100 mmHg according to 2017 ACC/AHA Guidelines
Not Eligible

You will not qualify if you...

  • Age less than 18 years
  • Systolic blood pressure less than 130 mmHg or greater than 160 mmHg at baseline
  • Diastolic blood pressure less than 80 mmHg or greater than 100 mmHg at baseline
  • Body Mass Index less than 30 kg/m^2 or greater than 45 kg/m^2
  • History of pulmonary hypertension
  • Past or present cardiovascular diseases including myocardial infarction, angina, cardiac arrhythmia, diabetes, stroke, TIA, or seizure
  • Taking three or more classes of hypertension medications at maximum dose or have resistant hypertension
  • History of angioedema
  • Estimated glomerular filtration rate less than 60 ml/min/1.73 m2
  • Urine albumin creatinine ratio 30 mg/g or higher
  • Hepatic transaminase levels more than three times the upper limit of normal
  • Significant psychiatric illness
  • Anemia (men, hematocrit less than 38%; women, hematocrit less than 36%)
  • Working night shifts or swing shifts
  • Women who are pregnant, breastfeeding, or able to become pregnant and not using acceptable birth control during the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

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Research Team

N

Nehal Vekariya, MS

CONTACT

D

Deborah Weber, BSN, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

OTHER

Number of Arms

4

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