CClinicalTrials.gg
RecruitingNCT07052539Updated Jul 4, 2025

The Epidemiology and Pathophysiology of Kidney Disease in HFpEF With Obesity

An observational study in Chronic Kidney Disease, Heart Failure With Preserved Ejection Fraction (HFPEF) and Obesity (Disorder), sponsored by University of Mississippi Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-04.

Sponsored by University of Mississippi Medical Center · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Disease
  • Heart Failure With Preserved Ejection Fraction (HFPEF)
  • Obesity (Disorder)
03

In context

Renal Insufficiency, Chronic

3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.

This study's planned enrollment of 60 is below the median of 200 across 867 observational studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

University of Mississippi Medical Center is the lead sponsor of 125 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Community-dwelling ambulatory participants who have HFpEF and obesity. We will compare with health participants and participants with obesity but without HFpEF.

Eligibility 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy Participants

    Other: High protein and sodium meal

  • Obese Participants without HFpEF

    Other: High protein and sodium meal

  • HFpEF and Obese Participants

    Other: High protein and sodium meal

Interventions

  • OtherHigh protein and sodium meal

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

06

What researchers measure

Primary outcomes

  1. Change in measured GFR

    Time frame: 5 hours

  2. Change in urine sodium excretion

    Time frame: 5 hours

07

Study locations

1 of 1 sites recruiting
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
    • Tekka Johnson · Contact · tjohnson23@umc.edu · 601-496-7834
    • Marissa C Tio, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07052539
Lead sponsor
University of Mississippi Medical Center
Responsible party
Sponsor
First posted
Jul 4, 2025
Start date
Jul 22, 2022
Primary completion
Jun 30, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Jul 4, 2025

Study contacts

Tekka Johnson
Contact
tjohnson23@umc.edu
601-496-7834
Marissa C Tio, MD
principal investigator · University of Mississippi Medical Center

Oversight

FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion