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RecruitingPhase 2 / Phase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether timing blood pressure treatment to the body's day-night cycle can restore a normal blood pressure pattern. It is for adults with obesity and high blood pressure. The treatment targets hormone systems that help control blood pressure.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Body mass index (BMI), a measure of weight compared with height, from 30 to 45.
  • High blood pressure with a top number from 130 to 160 and a bottom number from 80 to 100.

Who can't join

  • Under age 18, or BMI or blood pressure outside the ranges listed above.
  • History of high blood pressure in the lungs; heart or blood vessel disease, including heart attack, chest pain or uneven heartbeat; diabetes; stroke; mini-stroke; or seizures.
  • Taking 3 or more types of blood pressure medicine at the highest dose, or having blood pressure that resists treatment.
  • History of angioedema, which causes swelling under the skin.
  • Kidney filtering test (GFR) below 60, urine albumin-to-creatinine ratio of 30 or higher, or liver enzyme tests (AST and ALT) above 3 times the normal upper limit.
  • Serious mental illness, or anemia (low red blood cells), with hematocrit below 38% for men or 36% for women.
  • Working night shifts or changing shifts.
  • Pregnant or breastfeeding, or able to become pregnant but not using an accepted birth control method during the study. Not having sex is an accepted method.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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/m\^2 or \>45 kg/m\^2 * 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 * 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; * Significant psychiatric illness * 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)

Study sites (1)

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