NCT07052539 The Epidemiology and Pathophysiology of Kidney Disease in HFpEF With Obesity
| NCT ID | NCT07052539 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Mississippi Medical Center |
| Condition | Chronic Kidney Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-07-22 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-07-22 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Marissa C Tio, MD
PRINCIPAL INVESTIGATOR
University of Mississippi Medical Center
Frequently Asked Questions
Who can join the NCT07052539 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07052539 currently recruiting?
Yes, NCT07052539 is actively recruiting participants. Contact the research team at tjohnson23@umc.edu for enrollment information.
Where is the NCT07052539 trial being conducted?
This trial is being conducted at Jackson, United States.
Who is sponsoring the NCT07052539 clinical trial?
NCT07052539 is sponsored by University of Mississippi Medical Center. The principal investigator is Marissa C Tio, MD at University of Mississippi Medical Center. The trial plans to enroll 60 participants.
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