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NCT04055428 · ClinicalTrials.gov registry record · Phase 2
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
A Phase 2 study of Cardiovascular Diseases and Diabetes Mellitus, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT04055428: Recruiting Phase 2 study of Cardiovascular Diseases and Diabetes Mellitus, sponsored by University of Alabama at Birmingham.
NCT04055428 is a Phase 2 study of Cardiovascular Diseases and Diabetes Mellitus that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 200 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04055428, a Phase 2 study of Cardiovascular Diseases and Diabetes Mellitus, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease. The reasons for this are incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart that play a role in regulating the metabolic health of an individual. Low circulating level of NPs is an important contributor to increased risk for diabetes. The NP levels are relatively lower among Black individuals thus affecting their metabolic health and putting them at a higher risk for diabetes. This study aims to test the hypothesis that by augmenting NP levels using sacubitril/valsartan, among Black Individuals one can improve their metabolic health (as measured by insulin sensitivity \& energy expenditure) and help establish the role of NPs in the underlying mechanism behind increased risk for cardiometabolic disease in these population.
Primary Outcome
An assessment of the insulin sensitivity will be done at baseline and after 12 weeks of pharmacological intervention.
Conditions Studied
Interventions
- DRUG Sacubitril, Valsartan 97-103 mg Oral Tablet
- DRUG Valsartan 160 mg
- OTHER Intravenous Glucose Tolerance Test
- DIETARY_SUPPLEMENT Standardized Meals
- OTHER Exercise capacity VO2 maximum determination
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2020-08-15 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
What NCT04055428 shows while recruiting
NCT04055428 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower).
The record links to 7 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 5 interventions - of which Sacubitril, Valsartan 97-103 mg Oral Tablet is the first listed.
NCT04055428 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT04055428 about?
NCT04055428 is a clinical study titled "NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals". Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease. The reasons for this are incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart that play a role in regulating the meta...
What is the current status of trial NCT04055428?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2020-08-15. Estimated completion is 2027-05-31.
What conditions does trial NCT04055428 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Diabetes Mellitus, Metabolic Disease, Metabolism, Energy Expenditure.
What interventions are being tested in trial NCT04055428?
The interventions under investigation include: Sacubitril, Valsartan 97-103 mg Oral Tablet (DRUG), Valsartan 160 mg (DRUG), Intravenous Glucose Tolerance Test (OTHER), Standardized Meals (DIETARY_SUPPLEMENT), Exercise capacity VO2 maximum determination (OTHER).
Who is sponsoring clinical trial NCT04055428?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04055428 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
Similar trials for Cardiovascular Diseases
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 NCT04055428's enrollment target sits among peer trials
200 145th of 300 higher than 146 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases 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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