The Epidemiology and Pathophysiology of Kidney Disease in HFpEF With Obesity

NCT ID: NCT07052539

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-22

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy Participants

High protein and sodium meal

Intervention Type OTHER

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

Obese Participants without HFpEF

High protein and sodium meal

Intervention Type OTHER

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

HFpEF and Obese Participants

High protein and sodium meal

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High protein and sodium meal

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marissa C Tio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tekka Johnson

Role: CONTACT

601-496-7834

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tekka Johnson

Role: primary

601-496-7834

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-1040

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Kidney Disease After COVID-19
NCT05328986 COMPLETED
Determination of Kidney Function
NCT00001978 TERMINATED
Adipose Tissue & Uremia
NCT02902705 COMPLETED NA