Status:
UNKNOWN
PErirenal Adipose Tissue and RenaL Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
University Medical Center Groningen
Conditions:
Heart Failure With Preserved Ejection Fraction
Obesity
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria (patient category):
- Able and willing to give written informed consent
- Male and female subjects with age \>18 years
- A diagnosis of HFpEF based on typical symptoms (and/or signs), a LVEF \>50% (assessed within 12 months prior to baseline testing) and at least two of the following criteria10:
- For BMI \<35.0 kg/m2: NT pro-BNP ≥220 pg/mL For BMI ≥35.0 kg/m2: NT pro-BNP ≥125 pg/mL
- Left atrial volume index \>34 ml/m2 or Left ventricular mass index \>115g/m2 (men) or \>95g/m2 (women)
- E/e' ≥13 or e' average \<9 cm/s
- BMI \<25 or \>30
- Exclusion criteria for patient category:
- Amyloid cardiomyopathy or cardiomyopathy due to sarcoïdosis or M. Fabry, as reflected by medical history.
- Atrial fibrillation on ECG performed at screening
- Genetic hypertrophic (obstructive) cardiomyopathy.
- Severe (grade III/III) aortic stenosis.
- Female patient with childbearing potential, aiming to get pregnant or pregnant at the time of inclusion.
- Patients on (intermittent or continuous) hemodialysis
- Proven hypersensitivity to iodine contrast or any other contra-indication for computed tomography.
- Inclusion criteria for healthy controls:
- Able and willing to give written informed consent
- Male and female subjects with age \>18 years
- BMI \<25 or \>30
- Exclusion criteria for healthy controls:
- Diagnosis of any cardiovascular disease, either in the medical history or diagnosed during screening.
- Diagnosis of diabetes mellitus, defined as use of glucose lowering drugs
- Diagnosis of hypertension, defined as mean of 3 blood pressures measurements of \>140/90 mmHg at screening or use of blood pressure lowering drugs.
- Female patients with childbearing potential, either already pregnant or aiming to get pregnant at the time of inclusion.
- Proven hypersensitivity to iodine contrast or any other contra-indication for computed tomography.
Exclusion
Key Trial Info
Start Date :
February 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05219188
Start Date
February 1 2022
End Date
August 1 2022
Last Update
February 1 2022
Active Locations (1)
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1
University Medical Centre Groningen
Groningen, Netherlands, 9713GZ