Menu
Recruiting NCT07052539

The Epidemiology and Pathophysiology of Kidney Disease in HFpEF With Obesity

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High protein and sodium meal.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease, Heart Failure With Preserved Ejection Fraction (HFPEF), Obesity (Disorder). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other High protein and sodium meal
    Meal with 1g/kg protein content and 3900mg sodium

Primary outcome measures

  • Change in measured GFR [Time frame: 5 hours]
  • Change in urine sodium excretion [Time frame: 5 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Mississippi Medical Center — Jackson

Identifiers

NCT: NCT07052539 · 2021-1040

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗