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NCT04971720 · ClinicalTrials.gov registry record · Phase 2
PRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis
A Phase 2 study of Obesity and Hypertension, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT04971720: Recruiting Phase 2 study of Obesity and Hypertension, sponsored by University of Alabama at Birmingham.
NCT04971720 is a Phase 2 study of Obesity and Hypertension that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 160 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04971720, a Phase 2 study of Obesity and Hypertension, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Change in mean nocturnal systolic blood pressure will be analyzed in the two study arms (morning vs. evening dose of sacubitril/valsartan or valsartan) from baseline and after 28 days of intervention.
Conditions Studied
Interventions
- DRUG Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet
- DRUG Valsartan 80 mg Oral Tablet
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2022-02-18 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 2 |
What NCT04971720 shows while recruiting
NCT04971720 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (80% lower).
The record links to 6 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet is the first listed.
NCT04971720 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT04971720 about?
NCT04971720 is a clinical study titled "PRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis". 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 causin...
What is the current status of trial NCT04971720?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2022-02-18. Estimated completion is 2027-01-01.
What conditions does trial NCT04971720 study?
This clinical trial studies the following conditions: Obesity, Hypertension, Cardiovascular Diseases, Natriuretic Peptides, Nocturnal Blood Pressure.
What interventions are being tested in trial NCT04971720?
The interventions under investigation include: Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet (DRUG), Valsartan 80 mg Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04971720?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04971720 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04971720's enrollment target sits among peer trials
160 359th of 1053 higher than 691 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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