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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04971720
The ClinicalTrials.gov registry entry for NCT04971720 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (80% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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