How kidneys handle protein and salt in people with HFpEF and obesity
The Epidemiology and Pathophysiology of Kidney Disease in HFpEF With Obesity
This study will test how kidneys process protein and salt after a high-protein, high-sodium meal in adults with obesity and heart failure with preserved ejection fraction compared with healthy and obese-only adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Mississippi Medical Center Academic / other |
| Locations | 1 site (Jackson, Mississippi) |
| Trial ID | NCT07052539 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–75 who meet cohort criteria (healthy volunteers with BMI 25–30 and normal kidney function, adults with BMI >35 and eGFR ≥60 without heart failure, or adults with obesity and HFpEF as defined by the protocol) and who can attend in-person visits at the study site.
Not a fit: People with advanced kidney disease (eGFR <60 mL/min/1.73 m2), significant chronic illnesses, pregnancy or breastfeeding, recent hospitalization, active substance use, or contraindications to study procedures are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the study could clarify mechanisms linking obesity and HFpEF to kidney dysfunction and point to earlier detection strategies or targets for future treatments.
How similar studies have performed: Prior work has linked HFpEF and obesity to kidney problems, but using a meal provocation to characterize protein and sodium handling is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jackson, Mississippi
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.