Obesitas Heart failure with preserved ejection fraction (HFpEF)
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 4.1 Inclusion criteria (patient category): 1. Able and willing to give written informed consent 2. Male and female subjects with age >18 years 3. 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: a. For BMI =220 pg/mL For BMI >=35.0 kg/m2: NT pro-BNP >=125 pg/mL b. Left atrial volume index >34 ml/m2 or Left ventricular mass index >115g/m2 (men) or >95g/m2 (women) c. E/e* >=13 or e* average 30 Inclusion criteria for healthy controls: 1. Able and willing to give written informed consent 2. Male and female subjects with age >18 years 3. BMI 30
Exclusion criteria
Exclusion criteria: Exclusion criteria for patient category: 1. Amyloid cardiomyopathy or cardiomyopathy due to sarcoïdosis or M. Fabry, as reflected by medical history. 2. Genetic hypertrophic (obstructive) cardiomyopathy. 3. Severe (grade III/III) aortic stenosis. 4. Female patient with childbearing potential, aiming to get pregnant or pregnant at the time of inclusion. 6. Patients on (intermittent or continuous) hemodialysis 7. Proven hypersensitivity to iodine contrast, or any other contra-indication for CT diagnostics Exclusion criteria for healthy controls: 1. Diagnosis of any cardiovascular disease, either in the medical history or diagnosed during screening. 2. Diagnosis of diabetes mellitus, defined as use of glucose lowering drugs 3. Diagnosis of hypertension, defined as mean of 3 blood pressures measurements of >140/90 mmHg at screening or use of blood pressure lowering drugs. 4. Female patients with childbearing potential, either already pregnant or aiming to get pregnant at the time of inclusion. 5. Proven hypersensitivity to iodine contrast or any other contra-indication for CT diagnostics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the difference in volume of perirenal adipose tissue measured on abdominal CT in patients with HFpEF vs. healthy age, sex and BMI matched controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include the following: • The difference in renal (arterial and venous) blood flow as assessed with DCE-CT between HFpEF patients vs. healthy age, sex and BMI matched controls • The difference in renal venous flow pattern assessed with renal ultrasound between HFpEF patients vs. healthy age, sex and BMI matched controls • Estimated glomerular filtration rate assessed with DCE-CT. • Concentration of urine KIM-1 and OPN, serum creatinine and plasma cystatin C. • Correlation of NT pro BNP, plasma renin and plasma aldosterone concentration to perirenal adipose tissue diameter in patients with HFpEF, as well as to pulmonary arterial pressure as assessed with cardiac ultrasound • Differences between men and women with HFpEF for all aforementioned endpoints. Exploratory endpoint will include the following: • Correlation of clinical signs and symptoms of congestion to renal ultrasound flow patterns and to degree of renal damage as assessed with tubular markers • Pancreatic and hepatic aspects and size in patients with HFpEF based on late venous abdominal CT scan. | — |
Countries
Netherlands
Outcome results
None listed