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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 belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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
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 moreTrial 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?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,854 Previous Clinical Trials
47,817,712 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,287,760 Total Patients Enrolled
Pankaj Arora, MD, FAHAPrincipal InvestigatorUniversity of Alabama at Birmingham
5 Previous Clinical Trials
1,124 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My BMI is either below 30 or above 45.You have a history of angioedema (swelling of the skin and tissues beneath the skin).You have a serious mental health condition.I have a history of high blood pressure in the lungs.I am not pregnant, breastfeeding, and I use effective birth control or practice abstinence.You have a body mass index (BMI) between 30 and 45.I am under 18 years old.My kidney function is reduced, and I have protein in my urine.I am on the highest doses of 3 or more blood pressure medicines.I have a history of heart disease, stroke, diabetes, or seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Sacubitril/Valsartan Morning Dose
- Group 2: Sacubitril/Valsartan Evening Dose
- Group 3: Valsartan Morning Dose
- Group 4: Valsartan Evening Dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
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