What this study is
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.
What's being tested
- High protein and sodium meal
Intervention · OTHER
Meal with 1g/kg protein content and 3900mg sodium
Study details
- Sponsor
- University of Mississippi Medical Center
- Conditions
- Chronic Kidney Disease · Heart Failure With Preserved Ejection Fraction (HFPEF) · Obesity (Disorder)
- Enrolling
- 60 people
- Starts
- 2022-07-22
- Est. completion
- 2026-07-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Criteria for Cohort 1: Healthy Participants
- Adults 18-75 years old
- Normal kidney function
- No heart failure
- BMI 25-30kg/m2
- Adults 18-75 years old
- eGFR >= 60 mL/min/1.73m2
- BMI > 35 kg/m2
- 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
You can't join if
- 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
- 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
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Mississippi Medical Center
Jackson, Mississippi, United States
- Tekka Johnson · Contact601-496-7834tjohnson23@umc.edu
- Marissa C Tio, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Mississippi Medical Center
Study ID 2021-1040
Principal investigator
Marissa C Tio, MD
University of Mississippi Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.