What side effects are associated with this type of intervention?

Common treatments for high blood pressure include ACE inhibitors and ARBs, which can cause side effects like cough, elevated blood potassium levels, and kidney dysfunction. Calcium channel blockers may lead to swelling in the lower extremities, dizziness, and constipation. Thiazide diuretics can result in electrolyte imbalances, such as low sodium or potassium levels, and may increase the risk of gout. Beta blockers are associated with fatigue, cold extremities, and may exacerbate asthma or other respiratory conditions. Each medication class has its own profile of potential side effects, and these should be discussed with a healthcare provider to tailor treatment to individual needs.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure, including thiazide diuretics (e.g., hydrochlorothiazide), calcium channel blockers (e.g., amlodipine), ACE inhibitors (e.g., enalapril), ARBs (e.g., losartan), and mineralocorticoid receptor antagonists (e.g., spironolactone). These medications help manage blood pressure through various mechanisms such as reducing fluid retention, relaxing blood vessels, and inhibiting hormonal pathways that regulate blood pressure. Additionally, dietary salt intake plays a significant role in blood pressure regulation, and reducing salt intake is often recommended alongside pharmacological treatments to enhance efficacy.

What other types of research exist?

Promising alternatives to dietary salt restriction for high blood pressure patients include the use of SGLT2 inhibitors, adherence to the DASH diet, angiotensin inhibitors, and diuretics. Additionally, lifestyle modifications such as increased physical activity and weight management are important.

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Xanthine Oxidase Inhibitor

Salt Reduction Diet for High Blood Pressure (PEPC3 Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for high blood pressure include dietary modifications like the DASH diet and sodium restriction, as well as pharmacologic interventions such as ACE inhibitors, calcium channel blockers, and diuretics. The DASH diet and low sodium intake help reduce blood pressure by improving vascular function and reducing blood volume. ACE inhibitors lower blood pressure by blocking the formation of angiotensin II, a vasoconstrictor. Calcium channel blockers prevent calcium from entering heart and blood vessel cells, leading to vasodilation. Diuretics help eliminate excess sodium and water, reducing blood volume and pressure. These mechanisms are important for patients to understand as they guide effective management and adherence to treatment plans.

Phase < 1

Recruiting

Led By Lisa Washburn, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Born at less than 34 weeks gestational age (preterm cohort)

Born at greater than 36 weeks gestational age (term cohort)

Must not have

Congenital anomalies or genetic syndromes

Heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 49 to 56

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying young adults who were born prematurely to understand how salt affects their blood pressure. Researchers will see if stopping the body from making uric acid can help lower their blood pressure and improve heart health. The goal is to find better ways to prevent and treat heart disease in this high-risk group. Uric acid has been suspected to be a risk factor for high blood pressure since the 1870s, and lowering uric acid has shown potential in reducing blood pressure in individuals with high blood pressure.

Who is the study for?

This trial is for young adults born between 1990-1998, either prematurely (before 34 weeks) or at term (after 36 weeks), who are not twins. Participants should not have high blood pressure, be pregnant or breastfeeding, and must be free of serious conditions like active cancer, chronic kidney disease, liver or heart failure.

What is being tested?

The study is examining the effects of a drug called Allopurinol and dietary changes on how salt affects blood pressure in young adults who were born preterm. The goal is to understand better ways to manage potential risks associated with premature birth.

What are the potential side effects?

Allopurinol may cause side effects such as rash, digestive issues, and drowsiness. Dietary interventions might lead to temporary discomforts like changes in bowel habits or food cravings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was born before reaching 34 weeks of pregnancy.

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I was born after 36 weeks of pregnancy.

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I was born between 1990 and 1998.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a genetic condition or birth defect.

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I have heart failure.

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My cancer is currently active.

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My liver is not working properly.

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I am currently taking medication for high blood pressure.

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I have been diagnosed with high blood pressure.

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I have chronic kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 49 to 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 49 to 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 49 to 56 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Angiotensin II at baseline

Angiotensin-(1-7) at baseline

Augmentation index at baseline

+20 more

Secondary study objectives

24-hour potassium excretion at baseline

24-hour sodium excretion at baseline

24-hour uric acid excretion at baseline

+64 more

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: Preterm GroupExperimental Treatment2 Interventions

Subjects with very low birth weight (\<37 completed weeks' gestation and birth weight \<1500 g) will receive a dietary intervention (high/low salt diet) and FDA approved drug, Allopurinol

Group II: Term-born control groupActive Control1 Intervention

Subjects with birth weight ≥2500 g will receive a dietary intervention (high/low salt diet)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allopurinol

1999

Completed Phase 4

~6150

0 / 10Eligibility 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

Common treatments for high blood pressure include dietary modifications like the DASH diet and sodium restriction, as well as pharmacologic interventions such as ACE inhibitors, calcium channel blockers, and diuretics. The DASH diet and low sodium intake help reduce blood pressure by improving vascular function and reducing blood volume. ACE inhibitors lower blood pressure by blocking the formation of angiotensin II, a vasoconstrictor. Calcium channel blockers prevent calcium from entering heart and blood vessel cells, leading to vasodilation. Diuretics help eliminate excess sodium and water, reducing blood volume and pressure. These mechanisms are important for patients to understand as they guide effective management and adherence to treatment plans.

Moderator's view: Salt, cardiovascular risk, observational research and recommendations for clinical practice.Effect of lower sodium intake on health: systematic review and meta-analyses.Endothelin and NOS1/nitric oxide signaling and regulation of sodium homeostasis.