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NCT Number: NCT07052539

The Epidemiology and Pathophysiology of Kidney Disease in HFpEF With Obesity

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.

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Key information

Conditions

Chronic Kidney Disease Body Weight Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Failure With Preserved Ejection Fraction (HFpEF) Kidney Diseases Male Urogenital Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity (Disorder) Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location status: Recruiting

Location contact

Marissa C Tio, MD

PRINCIPAL_INVESTIGATOR

Tekka Johnson

CONTACT

[email protected]

601-496-7834

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High protein and sodium meal

Other

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

Primary outcomes

Change in measured GFR

Time frame: 5 hours
Change in urine sodium excretion

Time frame: 5 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Tekka Johnson

CONTACT

[email protected]

601-496-7834

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Jul 4, 2025
Registry last updated: Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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