Health TrialsbyHealthPanel

Genetic Architecture of Natriuretic Peptides and Blood Pressure Response

ConditionsHypertension (HTN)Cardiometabolic Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Low Salt Diet

    Dietary supplement

    8 days of diet with low salt content will be given to the study participants

  • High Salt Diet

    Dietary supplement

    8 days of diet with high salt content will be given to the study participants

  • Saline Infusion

    Dietary supplement

    2 Liters of normal saline infusion (0.25 ml/kg/min over 2 hours) will be given to the study participants at the end of each study period

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: High Natriuretic Peptide Polygenic ScoreExperimental treatment 3 interventions
Group B: Low Natriuretic Peptide Polygenic ScoreExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Change in 24h mean Systolic Blood Pressure (SBP)

Difference in the change in 24h mean SBP following high and low salt diets, between the polygenic score groups.

Time frame
3 weeks
2

Change in N-terminal pro-B-type Natriuretic Peptide (NTproBNP) (NTproBNP)

Difference in the change in NTproBNP levels following high and low salt diets, between the the polygenic score groups.

Time frame
3 weeks

Secondary outcomes

1

Change in 24h mean Diastolic Blood Pressure (DBP)

Difference in the change in the 24h mean DBP following high and low salt diets between the polygenic score groups.

Time frame
3 weeks
2

Change in Daytime Diastolic Blood Pressure (DBP)

Difference in the change in the Daytime DBP following high and low salt diets between the polygenic score groups.

Time frame
3 weeks
3

Change in Nighttime Diastolic Blood Pressure (DBP)

Difference in the change in the Nighttime DBP following high and low salt diets between the polygenic score groups.

Time frame
3 weeks
4

Change in Daytime Systolic Blood Pressure (SBP)

Difference in the change in the Daytime SBP following high and low salt diets between the polygenic score groups.

Time frame
3 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: