What is the mechanism of action of this treatment?

Sacubitril/Valsartan augments Natriuretic Peptide (NP) levels, which are crucial for regulating metabolic health, including insulin sensitivity and energy expenditure. This is particularly important for diabetes patients, as low NP levels are linked to a higher risk of diabetes and cardiometabolic diseases. Other common treatments include GLP-1 receptor agonists, which enhance insulin secretion and inhibit glucagon release, and SGLT-2 inhibitors, which reduce glucose reabsorption in the kidneys. These mechanisms are essential for managing blood glucose levels and reducing the risk of diabetes-related complications.

What side effects are associated with this type of intervention?

Common treatments for diabetes, such as Sodium-Glucose Co-Transporter 2 inhibitors (SGLT2-i) and Glucagon-Like Peptide-1 receptor agonists (GLP-1 RA), have specific side effects. SGLT2 inhibitors, like empagliflozin and canagliflozin, can increase the risk of urinary tract infections, genital infections, and in some cases, may lead to an increased risk of amputations, particularly below the knee. GLP-1 receptor agonists, such as liraglutide and semaglutide, are associated with gastrointestinal side effects like nausea, vomiting, and diarrhea, and there is a potential risk for pancreatitis and pancreatic cancer. Both classes of drugs have shown benefits in reducing cardiovascular events in patients with diabetes.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of diabetes that also offer cardiovascular benefits, similar to the effects being studied with Sacubitril/Valsartan. Notable examples include GLP-1 receptor agonists like liraglutide and semaglutide, which have shown significant reductions in cardiovascular events and improvements in glycemic control. Additionally, SGLT2 inhibitors such as canagliflozin, empagliflozin, and dapagliflozin have been approved for their dual benefits in managing blood glucose levels and reducing the risk of cardiovascular and renal events in diabetic patients.

What other types of research exist?

Promising alternatives to Sacubitril/Valsartan for diabetes patients include Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors and Glucagon-Like Peptide-1 (GLP-1) receptor agonists. SGLT2 inhibitors, such as empagliflozin and dapagliflozin, have demonstrated significant cardiovascular benefits and reduced renal risk. GLP-1 receptor agonists, like liraglutide and semaglutide, have also shown positive effects on cardiovascular outcomes. Both classes of drugs are well-supported by recent clinical trials and studies.

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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

Must not have

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)

Timeline

Screening 3 weeks

Treatment 3 months

Follow Up 1 week

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if sacubitril/valsartan can improve insulin sensitivity and energy use in Black individuals by increasing heart hormone levels. Black individuals are targeted because they often have lower levels of these hormones, leading to higher risks of diabetes. Valsartan has been studied for its potential to improve insulin sensitivity and β-cell function in various populations, including those with impaired glucose metabolism.

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.

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.

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

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I am 18 years old or older.

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

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I have a history of heart or blood vessel diseases.

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I have diabetes or my blood sugar/HbA1C levels are high.

Timeline

Screening ~ 3 weeks4 visits

Treatment ~ 3 months3 visits

Follow Up ~ 1 week3 visits

Screening ~ 3 weeks

Treatment ~ 3 months

Follow Up ~1 week

This trial's timeline: 3 weeks for screening, 3 months for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Natriuretic Hormones

Change in insulin sensitivity after natriuretic peptide augmentation

Secondary study objectives

Change in HBA1c levels

Change in HDL-C levels

Change in HOMA-IR

+22 more

Other study objectives

Change in Metabolomic Profile

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Sacubitril/Valsartan augments Natriuretic Peptide (NP) levels, which are crucial for regulating metabolic health, including insulin sensitivity and energy expenditure. This is particularly important for diabetes patients, as low NP levels are linked to a higher risk of diabetes and cardiometabolic diseases. Other common treatments include GLP-1 receptor agonists, which enhance insulin secretion and inhibit glucagon release, and SGLT-2 inhibitors, which reduce glucose reabsorption in the kidneys. These mechanisms are essential for managing blood glucose levels and reducing the risk of diabetes-related complications.

Diabetic nephropathy: newer therapeutic perspectives.