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Neprilysin Inhibitor

Sacubitril-Valsartan for High Blood Pressure (PRECISION-BP Trial)

Phase 2 & 3

Recruiting

Led By Pankaj Arora, MD, FAHA

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age more than or equal to 18 years of age

Be older than 18 years old

Must not have

Age less than 18, at screening.

BMI <30 kg/m^2 or >45 kg/m^2

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Awards & highlights

Summary

This trial seeks to find a way to lower the risk of cardiovascular events for obese individuals by specifically targeting the natriuretic peptides to control blood pressure.

Who is the study for?

This trial is for adults over 18 with obesity (BMI between 30 to 45) and high blood pressure (systolic BP 130-160mmHg, diastolic BP 80-100mmHg). It's not for those under 18, on multiple max-dose hypertension meds, with certain kidney/liver issues, pregnant/breastfeeding women not using birth control, or anyone with a history of severe cardiovascular disease.

What is being tested?

The study tests if timing the administration of Sacubitril-Valsartan or Valsartan can synchronize NP-RAAS-based blood pressure therapy with natural body rhythms to normalize daily blood pressure variations in obese individuals.

What are the potential side effects?

Potential side effects may include dizziness due to low blood pressure, kidney function changes, high potassium levels in the blood, coughing, and swelling around the eyes and lips.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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My BMI is either below 30 or above 45.

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I have a history of high blood pressure in the lungs.

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I have a history of heart disease, stroke, diabetes, or seizures.

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I am on the highest doses of 3 or more blood pressure medicines.

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My kidney function is reduced, and I have protein in my urine.

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I am not pregnant, breastfeeding, and I use effective birth control or practice abstinence.

Timeline

Screening ~ 3 days2 visits

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in mean nocturnal systolic blood pressure

Secondary outcome measures

Change in 24-hour mean diastolic blood pressure

Change in 24-hour mean systolic blood pressure

Change in 24-hour, daytime, and nocturnal ANP, BNP, NTproBNP, and renin levels

+12 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Sacubitril/Valsartan Morning DoseExperimental Treatment1 Intervention

We will enroll 40 adult obese individuals. Each participant will take the assigned dose of medication once in the morning and a placebo pill in the evening for 28 days. We evaluate Natriuretic Peptide-Renin-Angiotensin-Aldosterone System Rhythm Axis and Nocturnal Blood Pressure at baseline and after 28 days of intervention.

Group II: Sacubitril/Valsartan Evening DoseExperimental Treatment1 Intervention

We will enroll 40 adult obese individuals. Each participant will take the assigned dose of medication once in the evening and a placebo pill in the morning for 28 days. We evaluate Natriuretic Peptide-Renin-Angiotensin-Aldosterone System Rhythm Axis and Nocturnal Blood Pressure at baseline and after 28 days of intervention.

Group III: Valsartan Morning DoseActive Control1 Intervention

Group IV: Valsartan Evening DoseActive Control1 Intervention

0 / 8Eligibility criteria met