PErirenal Adipose Tissue and RenaL Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction
- Conditions
- Renal InsufficiencyHeart Failure With Preserved Ejection FractionObesity
- Interventions
- Radiation: 3.7 mS, CT radiation
- Registration Number
- NCT05219188
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
Rationale: Perirenal adipose tissue (PRAT) thickness has been associated to worsening renal function and hypertension. The role of PRAT in heart failure with a preserved ejection fraction (HFpEF) has never been established. The hypothesis of this study is that in patients with HFpEF the diameter of PRAT is increased compared with age, sex and BMI matched controls.
Objective: The main objective is to determine whether PRAT thickness is increased in patients with HFpEF. Secondary objectives are to determine whether PRAT thickness is correlated to whole kidney perfusion, renal venous flow patterns, markers of glomerular and tubular damage and dysfunction, NT pro-BNP, renin and aldosterone. Lastly, this study aims to determine whether these correlations are similar for men and women with HFpEF.
Study design: the proposed study is a single center, cross-sectional observational case-control study, including 30 HFpEF patients and 30 healthy controls.
Study population: Adult patients with HFpEF with a body mass index (BMI) of \<25.0 or \>30.0 and healthy age, sex and BMI-matched controls.
Intervention (if applicable): Not applicable. Main study parameters/endpoints: The primary endpoint will be the difference in diameter and volume of perirenal adipose tissue measured on dynamic contrast computed CT (DCE-CT) in patients with HFpEF vs. healthy age, sex and BMI matched controls.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participating subjects will be asked to visit the University Medical Center Groningen (UMCG) twice (once for screening, once for testing visit). During the testing visit they will undergo intravenous contrast abdominal CT, renal sonography, blood drawing and urine collection. Risks associated with these procedure are very limited, rare and include bleeding and infection for venapunction, and contact dermatitis for ultrasound gel. Adverse events for CT include hypersensitivity reactions to contrast agent, which include skin rash, hypotension and bronchospasm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Heart failure with preserved ejection fraction and BMI >30 3.7 mS, CT radiation Subjects will undergo DCE-CT. Radiation exposure has been calculated to be 3.7 mS, Iomeron dose admission during CT is 50 mL containing 714 mg/ml iomeprol Heart failure with preserved ejection fraction and BMI <25 3.7 mS, CT radiation Subjects will undergo DCE-CT. Radiation exposure has been calculated to be 3.7 mS, Iomeron dose admission during CT is 50 mL containing 714 mg/ml iomeprol Healthy controls with BMI >30 3.7 mS, CT radiation Subjects will undergo DCE-CT. Radiation exposure has been calculated to be 3.7 mS, Iomeron dose admission during CT is 50 mL containing 714 mg/ml iomeprol Healthy controls with BMI <25 3.7 mS, CT radiation Subjects will undergo DCE-CT. Radiation exposure has been calculated to be 3.7 mS, Iomeron dose admission during CT is 50 mL containing 714 mg/ml iomeprol
- Primary Outcome Measures
Name Time Method Perirenal fat thickness Up to 28 days after screening The primary objective is to determine whether perirenal adipose tissue thickness is increased in patients with HFpEF compared with age, sex and BMI-matched healthy controls
- Secondary Outcome Measures
Name Time Method Kidney perfusion Up to 28 days after screening Determine whether a greater PRAT volume correlates to impaired kidney perfusion on DCE- CT in patients with HFpEF
Renal venous flow patterns Up to 28 days after screening Determine whether a greater PRAT volume correlates to renal venous flow patterns assessed with ultrasound in patients with HFpEF
eGFR on CDE-CT Up to 28 days after screening Determine whether a greater PRAT volume correlates to glomerular filtration rate assessed with CDE- CT.
Renal biomarkers Up to 28 days after screening Determine whether a greater PRAT volume correlates to markers of glomerular and tubular damage and dysfunction (urinary KIM-1, urinary OPN, serum creatinine, plasma Cystatin C) in patients with HFpEF
Heart failure severity Up to 28 days after screening Determine whether a greater PRAT volume correlates to plasma NT pro-BNP, renin and aldosterone concentrations in patients with HFpEF as well as to pulmonary arterial pressure as assessed with cardiac ultrasound.
Sex differences Up to 28 days after screening Determine whether correlations between renal hemodynamics and PRAT volumes are different between men and women with HFpEF.
Trial Locations
- Locations (1)
University Medical Centre Groningen
🇳🇱Groningen, Netherlands