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NAUTICAL: Sacubitril/Valsartan for Cardiometabolic Health in Black Individuals

This study, called NAUTICAL, is looking at how a medication called sacubitril/valsartan (Entresto) might improve heart and metabolism health in Black individuals. Black individuals often have lower levels of natural hormones called natriuretic peptides (NPs), which are important for how your body uses insulin and energy. Researchers believe that increasing these NP levels with sacubitril/valsartan could help improve insulin sensitivity (how well your body responds to insulin) and overall metabolic health. You might be able to join if you are an adult (18 or older) who identifies as African-American or Black and have blood pressure between 120-160/80-100 mmHg. The study will measure changes in your insulin sensitivity and how your body uses energy after 12 weeks of treatment. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 200 participants. You would be randomly assigned, without you or the researchers knowing, to receive either sacubitril/valsartan or valsartan.
What's involved
You would take either sacubitril/valsartan or valsartan twice daily for 12 weeks. You would also have an intravenous glucose tolerance test (IVGTT) at the beginning and end of the 12 weeks, eat standardized meals, and have your exercise capacity measured.
Compensation
Not stated in the trial record.
Follow-up
Your insulin sensitivity and energy expenditure will be measured at 12 weeks after starting the interventions.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04055428

NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Alabama at Birmingham
~200 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Sacubitril, Valsartan 97-103 mg Oral TabletValsartan 160 mgIntravenous Glucose Tolerance TestStandardized MealsExercise capacity VO2 maximum determination

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in insulin sensitivity after natriuretic peptide augmentation
Measured over 12 weeks
+1 more outcome measured

Conditions

Diabetes Mellitus
Cardiovascular Diseases
Insulin Sensitivity/Resistance
Metabolic Disease
Natriuretic Peptides
Metabolism
Energy Expenditure

Explore related trials

Cardiovascular DisorderDiabetes Mellitus

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

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

Who to contact

Nehal Vekariya, MS
[email protected]
205-934-7173
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults: Age more than or equal to 18 years of age
Self-identified race/ethnicity as African-American or Black
Blood pressure: 120-160/80-100 mmHg

Exclusion

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)
Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, or cardiac arrhythmia)
BP more than 160/100 mmHg
BMI \>45 kg/m2
History of diabetes or fasting plasma glucose \>=126 mg/dL or HbA1C\>=6.5%
History of angioedema
Current or past (\<12 months) history of smoking
Estimated GFR \< 60 ml/min/1.73 m2; albumin-creatinine ratio ≥30 mg/g
Hepatic Transaminase (AST and ALT) levels \>3x the upper limit of normal
Significant psychiatric illness or seizure disorder
More than 2 Alcoholic drinks daily
Anemia (men, Hct \< 38%, Hb\<13 g/dL; women, Hct \<36%, Hb \<12 g/dL)
Inability to exercise on a treadmill

What this trial measures

  • Change in insulin sensitivity after natriuretic peptide augmentation12 weeks

    An assessment of the insulin sensitivity will be done at baseline and after 12 weeks of pharmacological intervention.

  • Change in energy expenditure after natriuretic peptide augmentation12 weeks

    An assessment of the resting energy expenditure will be done at baseline and after 12 weeks of pharmacological intervention.