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

Study acronym: PRECISION-BP
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Apr 21, 2025, no change to tracked fieldsv11-v12
  2. Collaborators expanded, about 7 wordsv10 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv9
  4. Site contact updatedv8
  5. Re-verified, no change to tracked fieldsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Eligibility criteria shortened, about 2 wordsv6 See this version in full on ClinicalTrials.gov ↗
  2. Study title shortened, about 2 wordsv5 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 1, 2023 to Feb 18, 2022 · Interventions: Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet (Drug), Standardized Study Diet (Other), Valsartan 80 mg Oral Tablet (Drug) to Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet (Drug), Valsartan 80 mg Oral Tablet (Drug) · Secondary endpoints revised (15) · 3 morev4 Show 6 more changesShow less
    • Start date changed from estimate of Jan 1, 2023 to Feb 18, 2022
    • Interventions: Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet (Drug), Standardized Study Diet (Other), Valsartan 80 mg Oral Tablet (Drug) to Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet (Drug), Valsartan 80 mg Oral Tablet (Drug)
    • Secondary endpoints revised (15)
    • Study description revised
    • Site details revised
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv3
  5. Interventions: Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet Evening Dose (Drug), Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet Morning Dose (Drug)… to Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet (Drug), Standardized Study Diet (Other), Valsartan 80 mg Oral Tablet (Drug) Secondary endpoints: 9 to 15 · Study description expanded, about 7 words · Eligibility criteria expanded, about 3 wordsv2 Show 3 more changesShow less
    • Secondary endpoints: 9 to 15
    • Study description expanded, about 7 words
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04971720
Lead Sponsor University of Alabama at Birmingham
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Obesity, Cardiovascular Diseases, Hypertension, Nocturnal Blood Pressure, Natriuretic Peptides, Renin-Angiotensin-Aldosterone System
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov