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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
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights

PRECISION-BP Trial 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.Check my eligibility
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.See study design
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.

PRECISION-BP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

PRECISION-BP Trial Timeline

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

PRECISION-BP 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
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 IV: Valsartan Evening DoseActive Control1 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.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,268,851 Total Patients Enrolled
Pankaj Arora, MD, FAHAPrincipal InvestigatorUniversity of Alabama at Birmingham
5 Previous Clinical Trials
1,124 Total Patients Enrolled

Media Library

Sacubitril (Neprilysin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04971720 — Phase 2 & 3
High Blood Pressure Research Study Groups: Sacubitril/Valsartan Morning Dose, Sacubitril/Valsartan Evening Dose, Valsartan Morning Dose, Valsartan Evening Dose
High Blood Pressure Clinical Trial 2023: Sacubitril Highlights & Side Effects. Trial Name: NCT04971720 — Phase 2 & 3
Sacubitril (Neprilysin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04971720 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still looking for more participants for this experiment?

"The trial is still recruiting patients, according to the clinicaltrials.gov listing. The posting went up on February 18th, 2022 and was edited as recently as October 14th of the same year."

Answered by AI

Are there any other ongoing research projects studying Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet?

"There are currently 39 ongoing clinical trials studying the efficacy of Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet. Of those, 8 are large Phase 3 trials. The majority of these studies are taking place in Montreal, Quebec; however, there are a total of 812 research sites worldwide."

Answered by AI

What is the therapeutic target for Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet?

"The ventricular dysfunction, left can often be treated by taking Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet. This medication is also able to help patients that are struggling with essential hypertension or have a history of cardiovascular events."

Answered by AI

How many people are being enrolled in this clinical trial?

"You are correct, the trial is still recruiting patients. The information on clinicaltrials.gov shows that the trial was posted on 2/18/2022 and updated on 10/14/2022. Currently, they are looking to enroll 160 patients from 1 location."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Alabama
How old are they?
< 18
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

i want to feel better. I am looking for a medication that will help me with my BP levels and address my BMI.
PatientReceived 1 prior treatment
Recent research and studies
~91 spots leftby Jan 2027