Chronic Kidney DiseaseNCT07052539
The Epidemiology and Pathophysiology of Kidney Disease in HFpEF With Obesity
An observational study of Chronic Kidney Disease and Heart Failure With Preserved Ejection Fraction (HFPEF), run by University of Mississippi Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Heart Failure With Preserved Ejection Fraction (HFPEF), Obesity (Disorder)
- What is being tested?
- High protein and sodium meal
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2022to 31 Jul 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling ambulatory participants who have HFpEF and obesity. We will compare with health participants and participants with obesity but without HFpEF.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Tekka Johnson, 601-496-7834, tjohnson23@umc.edu
Marissa C Tio, MD
About this study
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)
- Being tested
- High protein and sodium meal
- Medical subject headings
- Renal Insufficiency, Chronic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein and sodium mealOther
Meal with 1g/kg protein content and 3900mg sodium
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Not described Receives: Other: High protein and sodium meal | |
| Obese Participants without HFpEF | Not described Receives: Other: High protein and sodium meal | |
| HFpEF and Obese Participants | Not described Receives: Other: High protein and sodium meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measured GFR
Measured: 5 hours
Change in urine sodium excretion
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start22 Jul 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marissa C Tio, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052539
- Sponsor's protocol ID
- 2021-1040
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No