Dietary Interventions for Hypertension

Overseen By Nehal Vekariya, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Blood pressure meds

Disqualifiers: Cardiovascular disease, Kidney disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how genetic factors influence levels of natriuretic peptides (NPs)—hormones that help maintain heart health—and their effect on blood pressure. The study will test the effects of high-salt and low-salt diets on individuals with different genetic profiles related to NP levels. Participants with stage I or II hypertension (mild to moderate high blood pressure) who aren't taking multiple hypertension medications might be suitable candidates. Understanding these genetic influences could lead to personalized treatments for high blood pressure. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to personalized treatments for high blood pressure.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking two or more blood pressure medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that certain hormones, called natriuretic peptides (NPs), play a crucial role in maintaining heart health. Studies have found that low levels of these hormones can increase the risk of high blood pressure and diabetes. This trial explores how genes affect NP levels and their impact on blood pressure, using a polygenic score, which measures several genes.

Regarding safety, the trial primarily involves genetic testing, which is generally safe. No new drugs or treatments are involved, so participants will not experience the usual side effects associated with medications. Instead, the study uses genetic information to enhance understanding of heart health. Previous studies have safely used polygenic scores to assess heart disease risks without direct physical procedures. Therefore, participants can expect a low risk from the genetic assessments in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the dietary interventions for hypertension because they explore the genetic architecture of natriuretic peptides, which could offer a fresh approach to managing high blood pressure. Unlike standard treatments that typically involve medications such as ACE inhibitors, beta-blockers, or diuretics, this study looks at how genetic variations in natriuretic peptides can impact blood pressure control. By focusing on individuals with different polygenic scores for these peptides, the trial hopes to uncover personalized dietary strategies that could enhance or complement existing therapies. This approach could lead to more targeted and effective hypertension management, tailored to a person's unique genetic makeup.

What evidence suggests that this trial's treatments could be effective for hypertension?

Research has shown that low levels of certain heart hormones, called natriuretic peptides (NPs), are linked to a higher risk of developing high blood pressure. Studies have found that individuals with genes leading to higher NP levels might have a lower risk of this condition. In this trial, participants will be grouped based on their Polygenic Risk Scores (PRS) for NPs. Those in the "High Natriuretic Peptide Polygenic Score" arm may have a better chance of avoiding high blood pressure, while those in the "Low Natriuretic Peptide Polygenic Score" arm might be at a higher risk. Understanding these genetic differences aids in predicting and possibly preventing these health problems. ^{1 3 6 7 8}

Who Is on the Research Team?

Pankaj Arora, MD, FAHA

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals with hypertension or metabolic syndrome who are interested in how their genetics may influence their body's response to different salt levels. Participants should have a genetic risk score that suggests they might benefit from the study. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I agree to give samples for genetic testing and follow the study rules.

I am 18 years old or older.

My blood pressure is between 130-159/80-99 mm Hg.

Exclusion Criteria

I have a history of serious heart or brain blood flow problems.

I have a history of kidney disease.

I require insulin for my diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1 week each of high and low-salt diets in a random sequence, followed by a volume loading using a normal saline infusion protocol at the end of each diet period

4 weeks

Weekly visits (in-person)

Washout

Each diet period is followed by a week of washout

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Genetic Architecture of Natriuretic Peptides

Trial Overview The trial investigates how genetic factors related to Natriuretic Peptides (NPs) affect blood pressure responses to saline infusion, high-salt diet, and low-salt diet. It aims to support personalized medicine by linking NP levels with cardiovascular health outcomes.

How Is the Trial Designed?

Group I: Low Natriuretic Peptide Polygenic Score Experimental Treatment 3 Interventions

Experimental: Low NP PGS Group

Group II: High Natriuretic Peptide Polygenic Score Experimental Treatment 3 Interventions

Active Comparator: High NP PGS Group

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07118592

Genetic Architecture of Natriuretic Peptides and Blood ... Recent evidence has shown that low NP levels are associated with higher risk of cardiometabolic diseases like hypertension (HTN). Animal studies have shown that ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8481165/

Polygenic Risk Score: Clinically Useful Tool for Prediction of ... Polygenic risk score (PRS) as a potent risk prognosticator, being strongly associated with future cardiovascular events.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCGEN.121.003341

Polygenic Risk Score to Identify Subclinical Coronary ... Background:Polygenic risk scores (PRS) may enhance risk stratification for coronary heart disease among young adults.

4. researchprotocols.org researchprotocols.org/2023/1/e37011/PDF

The Predictive Value of A, B, and C-Type Natriuretic ... We postulate that (1) participants with lower levels of ANP or BNP at age 50 years will exhibit more advanced cardiac and metabolic impairment.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/joim.13352

Hypertension genetics past, present and future applications Later studies supported the polygenic nature of hypertension and estimated the heritability of clinical systolic BP (SBP) and diastolic BP (DBP) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9408577/

Life-Course Associations between Blood Pressure-Related ... Genetic information may help to identify individuals at increased risk for hypertension in early life, prior to the manifestation of elevated blood pressure ( ...

7. karger.com karger.com/pls/article/12/1/19/894757/Genetic-Variants-Associated-with-Hypertension-Risk

Genetic Variants Associated with Hypertension Risk Research has increased our knowledge about the relationship between naturally occurring genetic variation and risk of hypertension.

8. academic.oup.com academic.oup.com/europace/article/22/10/1463/5896137

Assessment of causality of natriuretic peptides and atrial ... Polygenic risk scores were significantly associated with the three natriuretic peptides. Polygenic risk scores were not significantly ...