Recruiting

Observational Study

Sponsor:

University of Mississippi Medical Center

Code:

NCT07052539

Conditions

Chronic Kidney Disease

Heart Failure With Preserved Ejection Fraction (HFPEF)

Obesity (Disorder)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

High protein and sodium meal

Study Details

Brief summary:

This research study wants to learn about Chronic Kidney Disease (CKD) with Obesity, and Heart Failure with preserved Ejection Fraction (HFpEF) and better ways to evaluate these diseases. HFpEF means that the heart is not able to fill properly with blood while it is resting so the amount of blood pumped out to the body is less than it would be if it was filling properly. The study is being done to describe the differences in how the kidneys handle protein and salt in participants with HFpEF and obesity compared to healthy persons.

Conditions

Chronic Kidney Disease

Heart Failure With Preserved Ejection Fraction (HFPEF)

Obesity (Disorder)

Study ID

NCT07052539

Start date

Jul 22, 2022

Status verified date

Jun, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Criteria for Cohort 1: Healthy Participants

Inclusion Criteria:

  • Adults 18-75 years old
  • Normal kidney function
  • No heart failure
  • BMI 25-30kg/m2

Exclusion Criteria:

  • Diagnosis of chronic illness
  • eGFR<60mL/min/1.73m2
  • Pregnancy or breast feeding
  • History of cutaneous or allergic reaction to iodine-based products of contrast dyes
  • Hemoglobin levels <7mg/dL
  • Acute illness or hospitalization event within 3 months
  • Unable to stop NSAIDs
  • Comorbid conditions: MM, amyloidosis, pheochromocytoma, SCD, metastatic brain lesions, advanced kidney disease, liver dysfunction, endotoxemia, hyperthyroidism
  • Current use of nicotine or recreational drugs, chronic drinker

Criteria for Cohort 2: Obese Participants without HFpEF

Inclusion Criteria:

  • Adults 18-75 years old
  • eGFR >= 60 mL/min/1.73m2
  • BMI > 35 kg/m2

Exclusion Criteria:

  • Diagnosis of Heart Failure
  • Diagnosis of chronic illness
  • eGFR<60mL/min/1.73m2
  • Pregnancy or breast feeding
  • History of cutaneous or allergic reaction to iodine-based products of contrast dyes
  • Hemoglobin levels <7mg/dL
  • Acute illness or hospitalization event within 3 months
  • Unable to stop NSAIDs
  • Comorbid conditions: MM, amyloidosis, pheochromocytoma, SCD, metastatic brain lesions, advanced kidney disease, liver dysfunction, endotoxemia, hyperthyroidism
  • Current use of nicotine or recreational drugs, chronic drinker

Criteria for Cohort 3: HFpEF and Obese Participants

Inclusion Criteria:

  • Adults 18-75 years old
  • eGFR >= 60 mL/min/1.73m2
  • BMI > 35 kg/m2
  • Diagnosis of HFpEF (chart diagnosis, LVEF > 55% on echo, H2FPEF score 6-9 or HFA-PEFF score 5 or 6

Exclusion Criteria:

  • NYHA class III/IV
  • Urinary retention screen +
  • Mobility issues
  • History of RRT or kidney transplant
  • Acute illness/hospitalization in the past 3 months
  • History of cancer, chemo, or XRT
  • Pregnant/breastfeeding
  • History of allergies to contrast
  • Hemoglobin < 7
  • Comorbid conditions: MM, amyloidosis, pheochromocytoma, SCD, metastatic brain lesions, advanced kidney disease, liver dysfunction, endotoxemia, hyperthyroidism
  • Unable to stop NSAIDs
  • Current use of nicotine or recreational drugs, chronic drinker

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Participants

Obese Participants without HFpEF

HFpEF and Obese Participants

Interventions

High protein and sodium meal

Meal with 1g/kg protein content and 3900mg sodium

Primary outcome measure

  • Change in measured GFR [ Time Frame: 5 hours ]
  • Change in urine sodium excretion [ Time Frame: 5 hours ]

Central Contacts and Locations

Central contacts

Tekka Johnson

601-496-7834tjohnson23@umc.edu

Locations

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Tekka Johnson

601-496-7834tjohnson23@umc.edu

Principal Investigator:

Marissa C Tio, MD

More Information

Sponsor

University of Mississippi Medical Center

Last update posted

Jul 4, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Mississippi Medical Center on 2025-07-04.