Clinical trial NCT05369416: Renal Metabolism in Salt-sensitive Human Blood Pressure
Official title: Renal Metabolism in Salt-sensitive Human Blood Pressure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: hypertension
high blood pressure
salt
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in renal regional tissue oxygenation in response to salt intake and salt sensitivity
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes in renal metabolites in response to a high sodium diet among individuals who are salt-sensitive versus insensitive
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin /Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Srividya Kidambi, MD
role: PRINCIPAL_INVESTIGATOR
References: