200 Participants Needed

Sacubitril/Valsartan for Metabolic Health in Black Individuals

VP
LP
NV
Overseen ByNehal Vekariya, MS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Alabama at Birmingham
Must be taking: Sacubitril/valsartan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Sacubitril/Valsartan for metabolic health in Black individuals?

Sacubitril/valsartan (Entresto) is effective in reducing the risk of cardiovascular death and hospitalization for heart failure, and studies have shown it improves heart function in Black patients, which may suggest potential benefits for metabolic health.12345

Is Sacubitril/Valsartan safe for humans?

Sacubitril/valsartan (Entresto) is generally considered safe for humans, but it can cause side effects like low blood pressure, dizziness, and in rare cases, liver injury. It should not be used during pregnancy or breastfeeding, and caution is advised when used with certain other medications.12367

What makes the drug sacubitril/valsartan unique for metabolic health in Black individuals?

Sacubitril/valsartan is unique because it combines two components: sacubitril, which inhibits neprilysin (an enzyme that breaks down certain proteins), and valsartan, an angiotensin II receptor blocker, offering a novel approach to managing heart failure and potentially improving metabolic health. This combination has shown superior results in reducing heart failure risks compared to traditional treatments like enalapril.138910

Research Team

Pankaj Arora, MD - Nutrition Obesity ...

Pankaj Arora, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

You identify yourself as African-American or Black.
I am 18 years old or older.
You identify as African-American or Black.
See 3 more

Exclusion Criteria

You are unable to walk or run on a treadmill.
Anemia (men, Hct < 38%, Hb<13 g/dL; women, Hct <36%, Hb <12 g/dL)
I have diabetes or my blood sugar/HbA1C levels are high.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacubitril/valsartan or valsartan alone for 12 weeks to assess changes in insulin sensitivity and energy expenditure

12 weeks
Baseline and after 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Sacubitril
  • Valsartan
Trial OverviewThe 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.
Participant Groups
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.

Sacubitril is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Entresto for:
  • Heart failure with reduced ejection fraction
🇺🇸
Approved in United States as Entresto for:
  • Heart failure with reduced ejection fraction
🇨🇦
Approved in Canada as Entresto for:
  • Heart failure with reduced ejection fraction
🇯🇵
Approved in Japan as Entresto for:
  • Heart failure with reduced ejection fraction

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Findings from Research

Sacubitril/valsartan (Entresto) significantly reduces the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure and reduced ejection fraction, outperforming enalapril in clinical studies.
While effective, sacubitril/valsartan can cause side effects such as low blood pressure, angioedema, and impaired kidney function, and it is contraindicated in pregnant or breastfeeding women and patients with severe liver impairment.
[Angiotensin-receptor- and neprilysin-inhibition: a new option against heart failure].Bruhn, C.[2021]
In a study of 224 patients with heart failure and reduced ejection fraction, approximately 38.4% were eligible for sacubitril/valsartan treatment after being on optimized guideline-directed medical therapy.
The analysis revealed that many patients remained symptomatic despite optimal treatment, highlighting the potential need for additional therapies like sacubitril/valsartan in managing chronic heart failure.
Real-Life Indications to Sacubitril/Valsartan Treatment in Patients With Chronic Systolic Heart Failure.Pinto, G., Tondi, L., Gemma, M., et al.[2021]
A case study of a 58-year-old male revealed that co-administration of atorvastatin and sacubitril/valsartan can lead to life-threatening rhabdomyolysis, highlighting the need for careful monitoring of muscle-related toxicity in patients taking these medications together.
The mechanism behind this adverse effect is that sacubitril inhibits the excretion of atorvastatin, increasing its concentration in the body and the risk of muscle damage; therefore, starting with a lower dose of atorvastatin or considering alternatives like rosuvastatin may be safer.
Approaches to management of rhabdomyolysis as the adverse effect of drug interaction between atorvastatin and sacubitril/valsartan: a case report.Siew, KSW., Abdul Hafidz, MI., Mohd Zaidan, FZB., et al.[2022]

References

[Angiotensin-receptor- and neprilysin-inhibition: a new option against heart failure]. [2021]
Real-Life Indications to Sacubitril/Valsartan Treatment in Patients With Chronic Systolic Heart Failure. [2021]
Approaches to management of rhabdomyolysis as the adverse effect of drug interaction between atorvastatin and sacubitril/valsartan: a case report. [2022]
Association between ethnicity and degree of improvement in cardiac function following initiation of sacubitril/valsartan. [2023]
Sacubitril/valsartan (Entresto) utilisation and prescribing patterns in the context of a reimbursement application system. [2021]
Adverse Events of Sacubitril/Valsartan: A Meta-analysis of Randomized Controlled Trials. [2022]
Sacubitril/valsartan-induced liver injury: A case report and literature review. [2023]
Effects of sacubitril/valsartan on both metabolic parameters and insulin resistance in prediabetic non-obese patients with heart failure and reduced ejection fraction. [2022]
Sacubitril/Valsartan (Entresto®)-Induced Hyponatremia. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Effects of Low-Dose Sacubitril/Valsartan on Different Stages of Cardiac Hypertrophy in Salt-Loaded Hypertensive Rats. [2021]