Heart Failure With Preserved Ejection FractionPEARL-HFPEFNCT05219188
PErirenal Adipose Tissue and RenaL Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction and Obesity, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Obesity, Renal Insufficiency
- What is being tested?
- 3.7 mS, CT radiation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2022to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic, stable HFpEF with and without obesity will be compared to healthy controls with and without obesity.
Who may be able to join
- 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
Show all 10Show fewer
- BMI <25 or >30
- Able and willing to give written informed consent
- Male and female subjects with age >18 years
- BMI <25 or >30
Who cannot join
- 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
Show all 12Show fewer
- Proven hypersensitivity to iodine contrast or any other contra-indication for computed tomography.
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Centre Groningen
Groningen, 9713GZ
Eva M Boorsma, MD, +31613744070, e.m.boorsma@umcg.nl
Adriaan A Voors, MD, PhD, +31503613874, a.a.voors@umcg.nl
About this study
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.
Read more
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.
- Being tested
- 3.7 mS, CT radiation
- Medical subject headings
- Obesity, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3.7 mS, CT radiationRadiation
Subjects will undergo dynamic contrast enhanced CT with an estimated radiation exposure of 3.7 mS
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: 3.7 mS, CT radiation | |
| 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 Receives: Radiation: 3.7 mS, CT radiation | |
| 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 Receives: Radiation: 3.7 mS, CT radiation | |
| 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 Receives: Radiation: 3.7 mS, CT radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perirenal fat thickness
The primary objective is to determine whether perirenal adipose tissue thickness is increased in patients with HFpEF compared with age, sex and BMI-matched healthy controls
Measured: Up to 28 days after screening
Secondary outcomes (6)
Kidney perfusion
Determine whether a greater PRAT volume correlates to impaired kidney perfusion on DCE- CT in patients with HFpEF
Measured: Up to 28 days after screening
Renal venous flow patterns
Determine whether a greater PRAT volume correlates to renal venous flow patterns assessed with ultrasound in patients with HFpEF
Measured: Up to 28 days after screening
eGFR on CDE-CT
Determine whether a greater PRAT volume correlates to glomerular filtration rate assessed with CDE- CT.
Measured: Up to 28 days after screening
Renal biomarkers
Determine whether a greater PRAT volume correlates to markers of glomerular and tubular damage and dysfunction (urinary KIM-1, urinary OPN, serum creatinine, plasma Cystatin C) in patients with HFpEF
Measured: Up to 28 days after screening
Heart failure severity
Determine whether a greater PRAT volume correlates to plasma NT pro-BNP, renin and aldosterone concentrations in patients with HFpEF as well as to pulmonary arterial pressure as assessed with cardiac ultrasound.
Measured: Up to 28 days after screening
Sex differences
Determine whether correlations between renal hemodynamics and PRAT volumes are different between men and women with HFpEF.
Measured: Up to 28 days after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.A.Voors, University Medical Center Groningen
- Investigators
- Adriaan A Voors, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219188
- Sponsor's protocol ID
- NL78282.042.21
- Acronym
- PEARL-HFPEF
- Status last verified
- Jan 2022
- First submitted
- 15 Dec 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32313610Jeong 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.
PubMed 33090257Sun 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.
PubMed 23463155
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PErirenal Adipose Tissue and RenaL Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT05219188
- Acronym / sponsor ID
- PEARL-HFPEF / NL78282.042.21
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Heart failure with preserved ejection fraction and BMI <25 | – | Radiation: 3.7 mS, CT radiationSubjects 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 |
| Heart failure with preserved ejection fraction and BMI >30 | – | Radiation: 3.7 mS, CT radiationSubjects 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 |
| Healthy controls with BMI <25 | – | Radiation: 3.7 mS, CT radiationSubjects 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 |
| Healthy controls with BMI >30 | – | Radiation: 3.7 mS, CT radiationSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic, stable HFpEF with and without obesity will be compared to healthy controls with and without obesity.
Key inclusion criteria (10 listed)
- 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:
- BMI <25 or >30
- Able and willing to give written informed consent
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3.7 mS, CT radiationSubjects will undergo dynamic contrast enhanced CT with an estimated radiation exposure of 3.7 mS | Radiation | Healthy controls with BMI <25, Healthy controls with BMI >30, Heart failure with preserved ejection fraction and BMI <25, Heart failure with preserved ejection fraction and BMI >30 |
Primary outcome
Perirenal fat thickness
Time frame: Up to 28 days after screening
The primary objective is to determine whether perirenal adipose tissue thickness is increased in patients with HFpEF compared with age, sex and BMI-matched healthy controls
6 secondary outcomes
Kidney perfusion
Time frame: Up to 28 days after screening
Renal venous flow patterns
Time frame: Up to 28 days after screening
eGFR on CDE-CT
Time frame: Up to 28 days after screening
Renal biomarkers
Time frame: Up to 28 days after screening
Heart failure severity
Time frame: Up to 28 days after screening
Sex differences
Time frame: Up to 28 days after screening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Results publication: PubMed 32313610Huang 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.
- Results publication: PubMed 33090257Jeong 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.
- Results publication: PubMed 23463155Sun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriaan A Voors, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction and Obesity, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva M Boorsma, MD (+31613744070, e.m.boorsma@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perirenal fat thickness (time frame: Up to 28 days after screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05219188, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.