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Active, Not Recruiting

NCT Number: NCT05369416

Renal Metabolism in Salt-sensitive Human Blood Pressure

Salt sensitive hypertension is a significant health problem worldwide and a primary modifiable risk factor for renal, cardiovascular, and cerebrovascular diseases. Yet, the underlying mechanisms remain poorly understood.

The proposed study determines how renal oxygenation and substrate metabolism differs between individuals with and without salt sensitivity, with the ultimate goal of identifying mechanisms, diagnostic criteria, and treatment strategies for salt sensitive hypertension.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin /Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

About this study

Seventy subjects will be enrolled and randomized to start either a low sodium diet (1200 mg/day) or high sodium diet (>4200 mg/day) for two weeks. After completion of two weeks, subjects will be switched to the 'other' diet for two weeks after a one-week wash-out. During the screening visit, subject's daily sodium intake will be assessed using multiple methods and further dietary information will be collected to prepare customized low sodium meals. During low sodium diet period, subjects will be supplied with food and will be asked to keep food logs. At the end of two-week period, the study activities described below will be carried out including BOLD MRI imaging along with imaging techniques to assess renal oxygenation levels and perfusion. During high sodium diet period, subjects will be either supplemented with sodium chloride tablets or high sodium foods to achieve a daily sodium intake above 4200 mg/day. If subjects already consume over 4200 mg/day of sodium, no changes will be made to their diet and assessment of oxygenation (BOLD MRI) and perfusion will take place after two weeks.

At the end of high sodium diet, 18 subjects will have renal vein sampling performed (this will be equally divided between salt-sensitive and salt-insensitive subjects and per subject preference as all may not want to have renal vein sampling). Subjects will be classified into salt sensitive or insensitive at the end of low sodium diet period based on BP response for further data analyses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking subjects
  • With a spectrum of BPs, ranging from those with Elevated BP through Stage 1 HTN, as defined by the 2017 ACC/AHA HTN guidelines

Exclusion criteria

  • Non-English speakers
  • BP ≤120/80 & ≥ 140/90 mmHg
  • H/o diabetes, congestive heart failure, cirrhosis of the liver, hypokalemia & other
  • electrolyte disturbances
  • H/o kidney disease
  • Use of glucocorticoids
  • Pregnant or nursing mothers
  • Presence of bleeding disorders
  • Use of anti-platelet and anticoagulant agents such as clopidogrel, aspirin, dabigatran, rivaroxaban etc
  • Daily sodium intake ≥ 6000 mg/day
  • Presence of pacemaker or other metallic implants
  • Allergy to iodinated contrast
  • Allergy to shellfish
  • Claustrophobia

Treatment and study plan

Low sodium diet

Other

Subjects will be started on a low sodium (food will be provided) for two weeks.

high sodium diet

Other

Subjects will be started on high sodium diet (regular diet supplemented with salt tablets to reach a daily intake of > 4200 mg/Day) for two weeks.

Primary outcomes

  1. Changes in renal regional tissue oxygenation in response to salt intake and salt sensitivity

    Time frame: 6 weeks

    70 subjects (~50% women, ~50% AA) will be recruited and salt sensitivity will be determined (defined as ≥8 mmHg decrease in systolic BP on a low Na+ diet). BOLD-MRI and MRI with arterial spin labeling (MRI-ASL) will be performed to assess renal regional tissue oxygenation and perfusion at baseline and after high and low Na+ diets.

Secondary outcomes

  1. Changes in renal metabolites in response to a high sodium diet among individuals who are salt-sensitive versus insensitive

    Time frame: 6 weeks

    In a sub-sample (n=18), metabolomic analysis on peripheral blood and urine samples at baseline and at the end of both diet periods will be performed. These measures will include circulating and urine levels of ketones, acetate and lactate. In addition, peripheral arterial and renal vein samples will be obtained after high Na+ diet period for metabolomic analysis. The concurrent sampling of urine, arterial, and renal venous blood and metabolomics analyses will allow us to comprehensively assess renal uptake and release of metabolites in humans for the first time.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
May 11, 2022
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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