PErirenal Adipose tissue and RenaL hemodynamics in patients with Heart Failure with Preserved Ejection Fractio

Recruiting

• Conditions: Obesitas; Heart failure with preserved ejection fraction (HFpEF); 10019280; 10038430

• Registration Number: NL-OMON52103
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

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 <35.0 kg/m2: NT pro-BNP >=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 <9 cm/s
4. BMI <25 or >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 <25 of >30

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be the difference in volume of perirenal adipose<br /><br>tissue measured on abdominal CT in patients with HFpEF vs. healthy age, sex and<br /><br>BMI matched controls.</p><br>