How kidneys handle protein and salt in people with HFpEF and obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, physiology-focused study that uses a standardized high-protein, high-sodium meal as a provocation to compare renal protein and sodium handling across participant groups. Adults 18–75 will be screened (including eGFR) and then provide timed blood and urine samples after the meal to measure protein excretion and sodium handling. The study compares healthy volunteers, adults with severe obesity but no heart failure, and adults with obesity and HFpEF to characterize differences in kidney responses. All visits take place at the University of Mississippi Medical Center and the protocol is intended to describe mechanisms rather than test a drug.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Mississippi Medical Center
  Jackson, Mississippi, United States Recruiting

Study contacts

• Principal investigator: Marissa C Tio, MD — University of Mississippi Medical Center
• Study coordinator: Tekka Johnson
• Email: tjohnson23@umc.edu
• Phone: 601-496-7834

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.