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Natriuretic Peptide Augmentation

Sacubitril/Valsartan for Metabolic Health in Black Individuals

Phase 2
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
Adults: Age more than or equal to 18 years of age
Adults: Age more than or equal to 18 years of age
Timeline
Screening 3 weeks
Treatment 3 months
Follow Up 1 weeks
Awards & highlights

Study Summary

This trial will test whether a medication can help improve the metabolic health of black individuals by augmenting natriuretic peptide levels.

Who is the study for?
This trial is for African-American or Black adults with blood pressure between 120-160/80-100 mmHg, who are not pregnant, don't smoke, and have no history of significant heart disease or diabetes. They must be able to exercise on a treadmill and not consume more than two alcoholic drinks daily.Check my eligibility
What is being tested?
The study tests if increasing Natriuretic Peptide levels using sacubitril/valsartan can improve metabolic health in Black individuals. It measures insulin sensitivity & energy expenditure to understand the role of NPs in cardiometabolic risk.See study design
What are the potential side effects?
Possible side effects include low blood pressure, kidney problems, high potassium levels, dizziness upon standing up too fast (orthostatic hypotension), coughing, and swelling around the eyes.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ 3 months
Follow Up ~1 weeks
This trial's timeline: 3 weeks for screening, 3 months for treatment, and 1 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Natriuretic Hormones
Change in insulin sensitivity after natriuretic peptide augmentation
Secondary outcome measures
Change in HBA1c levels
Change in HDL-C levels
Change in HOMA-IR
+22 more
Other outcome measures
Change in Metabolomic Profile

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sacubitril/ValsartanExperimental Treatment4 Interventions
We will enroll 100 adult Black individuals. Each participant will take the assigned dose of medication twice daily for 12 weeks. We evaluate insulin sensitivity and energy expenditure at baseline and after 12 weeks of intervention.
Group II: ValsartanActive Control4 Interventions
We will enroll 100 adult Black individuals. Each participant will take the assigned dose of medication twice daily for 12 weeks. We evaluate insulin sensitivity and energy expenditure at baseline and after 12 weeks 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
2,269,211 Total Patients Enrolled
15 Trials studying Diabetes
41,298 Patients Enrolled for Diabetes
Pankaj Arora, MD, FAHAPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham
5 Previous Clinical Trials
1,084 Total Patients Enrolled
1 Trials studying Diabetes
500 Patients Enrolled for Diabetes

Media Library

Sacubitril (Natriuretic Peptide Augmentation) Clinical Trial Eligibility Overview. Trial Name: NCT04055428 — Phase 2
Diabetes Research Study Groups: Valsartan, Sacubitril/Valsartan
Diabetes Clinical Trial 2023: Sacubitril Highlights & Side Effects. Trial Name: NCT04055428 — Phase 2
Sacubitril (Natriuretic Peptide Augmentation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04055428 — Phase 2

Frequently Asked Questions

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

What medical issues can be addressed through Exercise capacity VO2 maximum determination?

"Patients with essential hypertension, left ventricular dysfunction and insufficient response to single-drug therapy can find relief through the use of Exercise capacity VO2 maximum determination."

Answered by AI

What would be considered a successful outcome from this research?

"This 12-week trial seeks to observe the alteration in insulin sensitivity after natriuretic peptide augmentation. Secondary objectives of this research include tracking changes in fasting insulin levels, HOMA-IR, and adipose tissue mass following pharmacological treatment over a twelve week period."

Answered by AI

Is this clinical trial accepting new participants at the moment?

"As per information published on clinicaltrials.gov, this trial is currently recruiting patients and was first mentioned online in August 2020 with its latest update being recorded the same month two years later."

Answered by AI

How many participants are currently receiving treatment as part of this trial?

"Indeed, the information on clinicaltrials.gov conveys that this medical experiment is presently enrolling individuals. The project was initially posted on August 15th 2020 and lastly revised on August 15th 2022. They are seeking to secure 200 research participants from a solitary institution."

Answered by AI

Are there any health risks associated with determining the maximum oxygen uptake of a patient?

"Our team at Power assigned a score of 2 to the safety of Exercise capacity VO2 maximum determination, as this is a Phase 2 trial. This means there has been some evidence collected in support of its safety but none regarding efficacy."

Answered by AI

Have any other explorations been conducted concerning the ability to exercise as measured by VO2 maximum?

"Currently, eight Phase 3 studies are being conducted on Exercise capacity VO2 maximum determination in Montreal, Quebec. Additionally, a total of 826 clinical centres across the globe have trials running related to this research topic."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~87 spots leftby Dec 2026