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Xanthine Oxidase Inhibitor
Salt Reduction Diet for High Blood Pressure (PEPC3 Trial)
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 belowSelect...
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:Select...
I have a genetic condition or birth defect.
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I have heart failure.
Select...
My cancer is currently active.
Select...
My liver is not working properly.
Select...
I am currently taking medication for high blood pressure.
Select...
I have been diagnosed with high blood pressure.
Select...
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
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 moreSecondary study objectives
24-hour potassium excretion at baseline
24-hour sodium excretion at baseline
24-hour uric acid excretion at baseline
+64 moreAwards & 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
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.
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.
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,398 Previous Clinical Trials
2,460,045 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,941 Previous Clinical Trials
47,792,754 Total Patients Enrolled
Lisa Washburn, MDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a genetic condition or birth defect.I was born before reaching 34 weeks of pregnancy.I have heart failure.My cancer is currently active.My liver is not working properly.I was born after 36 weeks of pregnancy.I am currently taking medication for high blood pressure.I have been diagnosed with high blood pressure.I have chronic kidney disease.I was born between 1990 and 1998.
Research Study Groups:
This trial has the following groups:- Group 1: Term-born control group
- Group 2: Preterm Group
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: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.