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

NCT05219188 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-02-01

No results posted yet for this study

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

Interventions

RADIATION

3.7 mS, CT radiation

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

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Adriaan A Voors, MD, PhD · University Medical Center Groningen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-08-01
Completion
2022-08-01

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05219188 on ClinicalTrials.gov