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Genetic Architecture of Natriuretic Peptides and Blood Pressure Response

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The investigators will conduct a genotype-guided physiological clinical trial that aims to assess the genetic factors affecting NP levels and their impact on blood pressure and NP response to saline infusion, high-salt diet, and low-salt diet."
  • "The investigators will enroll 200 hypertensive participants for 4 weeks, during which the participants will receive 1 week each of high and low-salt diets in a random sequence, and undergo a volume loading using a normal saline infusion protocol at the end of each diet period."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how genes affect levels of heart-made hormones called natriuretic peptides. It tests how blood pressure and these hormones respond to salt water given into a vein and to high-salt and low-salt diets. It is for adults with high blood pressure.

Natriuretic peptides (NPs) are hormones produced by the heart and play an important role in maintaining cardiovascular health and have favorable metabolic benefits. Low NP levels are associated with an increased likelihood of the development of cardiometabolic diseases like diabetes and hypertension. NP levels are known to be highly heritable, with up to half of the differences in NP levels being explained by genetics. The investigators aim to describe the genetic architecture of NPs by examining the genetic variants associated with NPs, and generate and validate a polygenic score (PGS) for NPs. The investigators will use this NP PGS to examine the association of genetically determined NP levels with cardiometabolic and cardiovascular outcomes. The investigators will conduct a genotype-guided physiological clinical trial that aims to assess the genetic factors affecting NP levels and their impact on blood pressure and NP response to saline infusion, high-salt diet, and low-salt diet. These findings will help support personal medicine approaches to lower the increasing burden of hypertension in the United States.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You agree to give a sample for genetic testing and follow the study rules.
  • Your blood pressure has a top number of 130–159 and a bottom number of 80–99.

Who can't join

  • Your body mass index (BMI), a measure of weight compared with height, is over 45.
  • You have a history of blood pressure with a top number of 160 or higher or a bottom number of 100 or higher; or, during the study, a top number over 180 or a bottom number of 120 or higher.
  • You take 2 or more blood pressure medicines when checked for the study.
  • You have or have had a heart attack, angina (heart-related chest pain), an abnormal heartbeat, heart failure, stroke, mini-stroke, or seizure.
  • You are pregnant or breastfeeding.
  • You have a history of kidney disease or diabetes that needs insulin; or kidney tests show a filtering rate below 60 mL/min/1.73 m² or a urine albumin-to-creatinine ratio (a measure of protein in urine) of 30 mg/g or higher.
  • Your liver enzyme blood tests are more than 3 times the highest normal level.
  • You have anemia (low hemoglobin, which carries oxygen in blood): below 13 g/dL for men or below 12 g/dL for women.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age more than or equal to 18 years * Consenting to collection of genetic material and willing to adhere to study protocol * Stage I/II Hypertension (Systolic blood pressure: 130-159 and Diastolic blood pressure: 80-99 mm Hg) Exclusion Criteria: * Body mass index (BMI) more than 45 kg/m2 * History of uncontrolled hypertension (i.e., Systolic blood pressure more than or equal to 160 mmHg and/or Diastolic blood pressure more than or equal to 100 mmHg) * If taking more than or equal to 2 blood pressure medications at the time of screening * Systolic blood pressure more than 180 and/or Diastolic blood pressure more than or equal to 120 mmHg at any point in the study * Present or past history of major cardiovascular disease including myocardial infarction, angina, cardiac arrhythmia, heart failure, stroke, transient ischemic attack, or seizure. * Pregnant or breastfeeding individuals * History of kidney disease * History of insulin requiring diabetes * Estimated glomerular filtration rate less than 60ml/min/1.73 m2, albumin creatinine ratio more than or equal to 30 mg/g * Hepatic transaminase levels more than 3 times the upper limit of normal * Anemia (men, Hb less than 13 g/dL; women, Hb less than 12 g/dL)

Study sites (1)

AL