RECRUITING

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

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Conditions

ObesityCardiovascular DiseasesHypertensionNocturnal Blood PressureNatriuretic PeptidesRenin-Angiotensin-Aldosterone System

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-18
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04971720

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age more than or equal to 18 years of age
  2. * Body Mass Index between 30 to 45 kg/m\^2
  3. * 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
  1. * Age less than 18, at screening.
  2. * Systolic BP \<130 or \>160mmHg at baseline, or diastolic BP \<80 or \>100 mmHg at baseline
  3. * BMI \<30 kg/m\^2 or \>45 kg/m\^2
  4. * History of pulmonary hypertension
  5. * Have any past or present illness of cardiovascular disease including myocardial infarction, angina, cardiac arrhythmia, diabetes, stroke, TIA, or seizure.
  6. * Participants who are taking 3 or more classes of hypertension medications on the maximum dose or with resistant hypertension
  7. * History of angioedema
  8. * Estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73 m2 (CKD-EPI equation); urine albumin creatinine ratio ≥30 mg/g
  9. * Hepatic Transaminase (AST and ALT) levels \>3x the upper limit of normal;
  10. * Significant psychiatric illness
  11. * Anemia (men, Hct \< 38%; women, Hct \<36%)
  12. * Participants working night shifts or swing shifts
  13. * 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)

Contacts and Locations

Study Contact

Nehal Vekariya, MS
CONTACT
205-934-7173
nvekariya@uabmc.edu
Deborah Weber, BSN, RN
CONTACT
205-975-9964
dlowe@uabmc.edu

Principal Investigator

Pankaj Arora, MD, FAHA
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Pankaj Arora, MD, FAHA, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-18
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2022-02-18
Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

  • Natriuretic Peptides
  • Nocturnal Blood Pressure
  • Renin-Angiotensin-Aldosterone System
  • Obesity

Additional Relevant MeSH Terms

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