PErirenal Adipose Tissue and RenaL Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction

NCT ID: NCT05219188

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-08-01

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.

Conditions

Heart Failure With Preserved Ejection Fraction; Obesity; Renal Insufficiency

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Heart failure with preserved ejection fraction and BMI <25

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

3.7 mS, CT radiation

Intervention Type: RADIATION

Subjects will undergo dynamic contrast enhanced CT with an estimated radiation exposure of 3.7 mS

Heart failure with preserved ejection fraction and BMI >30

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

3.7 mS, CT radiation

Intervention Type: RADIATION

Subjects will undergo dynamic contrast enhanced CT with an estimated radiation exposure of 3.7 mS

Healthy controls with BMI <25

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

3.7 mS, CT radiation

Intervention Type: RADIATION

Subjects will undergo dynamic contrast enhanced CT with an estimated radiation exposure of 3.7 mS

Healthy controls with BMI >30

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

3.7 mS, CT radiation

Intervention Type: RADIATION

Subjects will undergo dynamic contrast enhanced CT with an estimated radiation exposure of 3.7 mS

Interventions

3.7 mS, CT radiation

Subjects will undergo dynamic contrast enhanced CT with an estimated radiation exposure of 3.7 mS

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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:

1. For BMI <35.0 kg/m2: NT pro-BNP ≥220 pg/mL For BMI ≥35.0 kg/m2: NT pro-BNP ≥125 pg/mL

2. Left atrial volume index >34 ml/m2 or Left ventricular mass index >115g/m2 (men) or >95g/m2 (women)

3. E/e' ≥13 or e' average <9 cm/s

4. BMI <25 or >30

1. Able and willing to give written informed consent

2. Male and female subjects with age >18 years

3. BMI <25 or >30

Exclusion Criteria

1. Amyloid cardiomyopathy or cardiomyopathy due to sarcoïdosis or M. Fabry, as reflected by medical history.

2. Atrial fibrillation on ECG performed at screening

3. Genetic hypertrophic (obstructive) cardiomyopathy.

4. Severe (grade III/III) aortic stenosis.

5. 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 computed tomography.

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 computed tomography.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

A.A.Voors

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adriaan A Voors, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Centre Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Eva M Boorsma, MD

Role: CONTACT

e.m.boorsma@umcg.nl

+31613744070

Adriaan A Voors, MD, PhD

Role: CONTACT

a.a.voors@umcg.nl

+31503616161 ext. 13874

Facility Contacts

Eva M Boorsma, MD

Role: primary

e.m.boorsma@umcg.nl

+31613744070

Adriaan A Voors, MD, PhD

Role: backup

a.a.voors@umcg.nl

+31503613874

References

Huang N, Mao EW, Hou NN, Liu YP, Han F, Sun XD. Novel insight into perirenal adipose tissue: A neglected adipose depot linking cardiovascular and chronic kidney disease. World J Diabetes. 2020 Apr 15;11(4):115-125. doi: 10.4239/wjd.v11.i4.115.

Reference Type: RESULT

PMID: 32313610 (View on PubMed)

Jeong S, Park SB, Chang IH, Shin J, Chi BH, Park HJ, Lee ES. Estimation of renal function using kidney dynamic contrast material-enhanced CT perfusion: accuracy and feasibility. Abdom Radiol (NY). 2021 May;46(5):2045-2051. doi: 10.1007/s00261-020-02826-7. Epub 2020 Oct 22.

Reference Type: RESULT

PMID: 33090257 (View on PubMed)

Sun X, Han F, Miao W, Hou N, Cao Z, Zhang G. Sonographic evaluation of para- and perirenal fat thickness is an independent predictor of early kidney damage in obese patients. Int Urol Nephrol. 2013 Dec;45(6):1589-95. doi: 10.1007/s11255-013-0404-4. Epub 2013 Mar 6.

Reference Type: RESULT

PMID: 23463155 (View on PubMed)

Other Identifiers

NL78282.042.21

Identifier Type: -

Identifier Source: org_study_id