Heart Failure With Preserved Ejection FractionSLIM-HFpEFNCT04886713
Adipose Tissue Inflammation in HFpEF
An observational study of Heart Failure With Preserved Ejection Fraction and Obesity, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
Trial summary
To evaluate the role of adipose tissue inflammation in patients with heart failure with preserved ejection fraction (HFpEF). Patients undergoing coronary artery bypass grafting with HFpEF and without heart failure will be included in this prospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Obesity
- What is being tested?
- Adipose and myocardial tissue sampling, Cardiac magnetic resonance imaging and Cardiopulmonary exercise testing
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2019to 15 Mar 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
- No healthy volunteers
- Adult, Older adult
Study population: Stable patients with indication for coronary bypass crafting will be prospectively identified at the Heart Center Leipzig (either during the admission process for patients referred to surgery or at the time of coronary angiography when the indication for operative revascularization is established). Patients will be grouped according to the presence of HFpEF and obesity in order to generate 3 distinct patient groups, defined as: 1. Obesity HFpEF 2. Obesity Non-HF 3. Non-Obesity Non-HF
Who may be able to join
- HFpEF: Left ventricular ejection fraction ≥ 50%, NT-pro-BNP ≥ 125ng/l, evidence of structural heart diseases (diastolic dysfunction, left ventricular-hypertrophy or left atrial-dilatation), BMI ≥ 30kg/m²
- Non-HF patients: No history of heart failure, Left ventricular ejection fraction > 50% and NT-pro-BNP <125ng/l
Who cannot join
- Previous cardiac surgery / coronary intervention / myocardial infraction
- Acute coronary syndrome (Serum levels of troponin T >50 pg/ml)
- Left ventricular ejection fraction < 50%
- Indication for concomitant valvular surgery
- Planned beating heart coronary bypass surgery
- Hemodynamic instability
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- Contraindication for magnetic resonance imaging
- Pregnancy
- Age < 18 years
- No informed consent possible
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heart Centre at University Leipzig
Leipzig, Saxony, 04289
Karl-Patrik Kresoja, MD, 0341 865 252596, karl-patrik.kresoja@medizin.uni-leipzig.de
Philipp Lurz, MD, PhD, philipp.lurz@medizin.uni-leipzig.de
About this study
Official title: Adipose Tissue Inflammation in the Development, Maintenance and Functional Impairments in Heart Failure With Preserved Ejection Fraction
To evaluate the role of adipose tissue inflammation in patients with heart failure with preserved ejection fraction (HFpEF). Patients undergoing coronary artery bypass grafting with HFpEF and without heart failure will be included in this prospective study. Epicardial, paracardial, paraaortic/paravascular, subcutaneous adipose tissue samples as well as myocardial tissue will be harvested during cardiac surgery. Inflammatory patterns of these tissues and their relation to circulating markers will be investigated.
Read the detailed description
Heart Failure with preserved Ejection Fraction (HFpEF) is a growing public health concern with an increasing incidence, high morbidity and mortality and no proven therapy to date. Better characterization of individual pathophysiological implications is mandatory to develop effective therapeutic strategies or preventive programs. Obesity is an important risk factor for the development of HFpEF and also modulates its course possibly by its association with systemic inflammation. However, the role of adipose tissue (AT) inflammation in the development, maintenance and functional impairments in HFpEF has been under-investigated. Dysfunctional AT leads to a shift from a protective adipokine profile to an imbalanced production of pro-inflammatory, pro-oxidant and pro-fibrotic adipokines. Besides depot specific paracrine effects, the overall secretory activity or endocrine effect of AT can be evaluated in peripheral plasma.
The investigators hypothesize that adipose inflammation distinguishes obese HFpEF patients from obese patients without heart failure and that adipose tissue inflammation is a key driver the maintenance and development of HFpEF and determines functional capacity.
In addition the investigators hypothesize that the degree of myocardial inflammatory alterations is more closely related to epicardial tissue alterations than subcutaneous or visceral AT tissue inflammation or peripheral adipokine profiles.
- Being tested
- Adipose and myocardial tissue sampling, Cardiac magnetic resonance imaging, Cardiopulmonary exercise testing
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose and myocardial tissue samplingDiagnostic test
After median sternotomy tissue samples will be collected from the epicardial space, the abdominal wall and the myocardium.
Cardiac magnetic resonance imagingDiagnostic test
Magnetic resonance imaging will be performed at 1.5 Tesla ('Intera', Philips Medical Systems, Best, The Netherlands). All subjects will be examined in the supine position with initial anatomy scans to cover the thorax to the first sacral vertebrae. The magnetic resonance imaging protocol is summarized in Figure 4.
The following imaging parameters will be acquired:
- Biventricular end-diastolic and end-systolic volume, ejection fraction, stroke volume
- Biventricular mass, wall thickness
- T1 mapping; native and > 10 minutes post contrast injection as an estimate of left ventricular diffuse fibrosis and extracellular volume
- Late enhancement for detection of regional fibrosis and scar
- Myocardial feature tracking for analysis of deformation/motion
- Epicardial fat volume
Cardiopulmonary exercise testingDiagnostic test
After completion of a regular cardiac rehabilitation program patients are scheduled to undergo their discharge examination at 3 to 4 weeks after the operation in order to be functionally characterized. Cardiopulmonary exercise testing will be performed, if possible by patients condition, on a mechanically braked bicycle ergometer and respiratory gas exchange analysis via a mouthpiece or facemask.
| Study group | Role | What they receive |
|---|---|---|
| Obese HFpEF | Left ventricular-EF ≥ 50%, N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥ 125ng/l, evidence of structural heart diseases (diastolic dysfunction, Left ventricular-hypertrophy or Left atrial-dilatation) BMI ≥30 kg/m² Receives: Diagnostic Test: Adipose and myocardial tissue sampling; Diagnostic Test: Cardiac magnetic resonance imaging; Diagnostic Test: Cardiopulmonary exercise testing | |
| Obese controls | No history of heart failure, Left ventricular-EF > 50% and NT-pro-BNP <125ng/l, BMI ≥ 30kg/m² Receives: Diagnostic Test: Adipose and myocardial tissue sampling; Diagnostic Test: Cardiac magnetic resonance imaging; Diagnostic Test: Cardiopulmonary exercise testing | |
| Lean control | No history of heart failure, Left ventricular-EF > 50% and NT-pro-BNP <125ng/l, BMI < 30kg/m² Receives: Diagnostic Test: Adipose and myocardial tissue sampling; Diagnostic Test: Cardiac magnetic resonance imaging; Diagnostic Test: Cardiopulmonary exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue inflammation
Adipose tissue inflammation and distribution as well as association with adipokines
Measured: Tissue collection during surgery.
Secondary outcomes (6)
Evaluation of serum adipokine levels
Circulating adipokine levels will be measured at a central lab.
Measured: At baseline, before surgery.
Cardiac MRI - Myocardial function
Myocardial function and extent of myocardial fibrosis.
Measured: At baseline, before surgery.
Cardiac MRI - Epicardial fat
Extent of epicardial fat.
Measured: At baseline, before surgery.
Echocardiography
Measurement of standard echocardiographic parameters of left- and right- ventricular systolic and diastolic function.
Measured: At baseline, before surgery and at follow-up approximately three months after surgery.
Functional capacity on spiroergometry
Follow-up investigation by spiroergometry to assess post-surgical functional capacity. Measures included Peak Oxygen consumption (VO2 max) and oxygen consumption at anaerobic threshold (AT VO2)
Measured: At follow-up approximately three months after surgery.
Stress echocardiography
Assessment of echocardiographic parameters of left- and right- ventricular systolic and diastolic function during semi-supine bicycle exercise. These measures include the change of E/E' during exercise for the left ventricle and the change of tricuspid annular plane systolic excursion (TAPSE) during exercise for the right ventricle.
Measured: At follow-up approximately three months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Nov 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Lurz, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886713
- Sponsor's protocol ID
- SLIM-HFpEF V1.0
- Acronym
- SLIM-HFpEF
- Status last verified
- May 2021
- First submitted
- 25 Mar 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Inflammation in the Development, Maintenance and Functional Impairments in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT04886713
- Acronym / sponsor ID
- SLIM-HFpEF / SLIM-HFpEF V1.0
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 14 May 2021 (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.
To evaluate the role of adipose tissue inflammation in patients with heart failure with preserved ejection fraction (HFpEF). Patients undergoing coronary artery bypass grafting with HFpEF and without heart failure will be included in this prospective study. Epicardial, paracardial, paraaortic/paravascular, subcutaneous adipose tissue samples as well as myocardial tissue will be harvested during cardiac surgery. Inflammatory patterns of these tissues and their relation to circulating markers will be investigated.
Detailed description
Heart Failure with preserved Ejection Fraction (HFpEF) is a growing public health concern with an increasing incidence, high morbidity and mortality and no proven therapy to date. Better characterization of individual pathophysiological implications is mandatory to develop effective therapeutic strategies or preventive programs. Obesity is an important risk factor for the development of HFpEF and also modulates its course possibly by its association with systemic inflammation. However, the role of adipose tissue (AT) inflammation in the development, maintenance and functional impairments in HFpEF has been under-investigated. Dysfunctional AT leads to a shift from a protective adipokine profile to an imbalanced production of pro-inflammatory, pro-oxidant and pro-fibrotic adipokines. Besides depot specific paracrine effects, the overall secretory activity or endocrine effect of AT can be evaluated in peripheral plasma.
The investigators hypothesize that adipose inflammation distinguishes obese HFpEF patients from obese patients without heart failure and that adipose tissue inflammation is a key driver the maintenance and development of HFpEF and determines functional capacity.
In addition the investigators hypothesize that the degree of myocardial inflammatory alterations is more closely related to epicardial tissue alterations than subcutaneous or visceral AT tissue inflammation or peripheral adipokine profiles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese HFpEF | – | Diagnostic Test: Adipose and myocardial tissue sampling, Diagnostic Test: Cardiac magnetic resonance imaging, Diagnostic Test: Cardiopulmonary exercise testingLeft ventricular-EF ≥ 50%, N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥ 125ng/l, evidence of structural heart diseases (diastolic dysfunction, Left ventricular-hypertrophy or Left atrial-dilatation) BMI ≥30 kg/m² |
| Obese controls | – | Diagnostic Test: Adipose and myocardial tissue sampling, Diagnostic Test: Cardiac magnetic resonance imaging, Diagnostic Test: Cardiopulmonary exercise testingNo history of heart failure, Left ventricular-EF > 50% and NT-pro-BNP <125ng/l, BMI ≥ 30kg/m² |
| Lean control | – | Diagnostic Test: Adipose and myocardial tissue sampling, Diagnostic Test: Cardiac magnetic resonance imaging, Diagnostic Test: Cardiopulmonary exercise testingNo history of heart failure, Left ventricular-EF > 50% and NT-pro-BNP <125ng/l, BMI < 30kg/m² |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable patients with indication for coronary bypass crafting will be prospectively identified at the Heart Center Leipzig (either during the admission process for patients referred to surgery or at the time of coronary angiography when the indication for operative revascularization is established). Patients will be grouped according to the presence of HFpEF and obesity in order to generate 3 distinct patient groups, defined as: 1. Obesity HFpEF 2. Obesity Non-HF 3. Non-Obesity Non-HF
Key inclusion criteria (2 listed)
- HFpEF: Left ventricular ejection fraction ≥ 50%, NT-pro-BNP ≥ 125ng/l, evidence of structural heart diseases (diastolic dysfunction, left ventricular-hypertrophy or left atrial-dilatation), BMI ≥ 30kg/m²
- Non-HF patients: No history of heart failure, Left ventricular ejection fraction > 50% and NT-pro-BNP <125ng/l
Key exclusion criteria (10 listed)
- Previous cardiac surgery / coronary intervention / myocardial infraction
- Acute coronary syndrome (Serum levels of troponin T >50 pg/ml)
- Left ventricular ejection fraction < 50%
- Indication for concomitant valvular surgery
- Planned beating heart coronary bypass surgery
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 |
|---|---|---|
| Adipose and myocardial tissue samplingAfter median sternotomy tissue samples will be collected from the epicardial space, the abdominal wall and the myocardium. | Diagnostic test | Lean control, Obese HFpEF, Obese controls |
| Cardiac magnetic resonance imagingMagnetic resonance imaging will be performed at 1.5 Tesla ('Intera', Philips Medical Systems, Best, The Netherlands). All subjects will be examined in the supine position with initial anatomy scans to cover the thorax to the first sacral vertebrae. The magnetic resonance imaging protocol is summarized in Figure 4. The following imaging parameters will be acquired: * Biventricular end-diastolic and end-systolic volume, ejection fraction, stroke volume * Biventricular mass, wall thickness * T1 mapping; native and > 10 minutes post contrast injection as an estimate of left ventricular diffuse fibrosis and extracellular volume * Late enhancement for detection of regional fibrosis and scar * Myocardial feature tracking for analysis of deformation/motion * Epicardial fat volume | Diagnostic test | Lean control, Obese HFpEF, Obese controls |
| Cardiopulmonary exercise testingAfter completion of a regular cardiac rehabilitation program patients are scheduled to undergo their discharge examination at 3 to 4 weeks after the operation in order to be functionally characterized. Cardiopulmonary exercise testing will be performed, if possible by patients condition, on a mechanically braked bicycle ergometer and respiratory gas exchange analysis via a mouthpiece or facemask. | Diagnostic test | Lean control, Obese HFpEF, Obese controls |
Primary outcome
Adipose tissue inflammation
Time frame: Tissue collection during surgery.
Adipose tissue inflammation and distribution as well as association with adipokines
6 secondary outcomes
Evaluation of serum adipokine levels
Time frame: At baseline, before surgery.
Cardiac MRI - Myocardial function
Time frame: At baseline, before surgery.
Cardiac MRI - Epicardial fat
Time frame: At baseline, before surgery.
Echocardiography
Time frame: At baseline, before surgery and at follow-up approximately three months after surgery.
Functional capacity on spiroergometry
Time frame: At follow-up approximately three months after surgery.
Stress echocardiography
Time frame: At follow-up approximately three months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Heart Center Leipzig - University Hospital at 1 site in Germany.
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 2 inclusion and 10 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 14 May 2021. 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 Germany. 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 Karl-Patrik Kresoja, MD (+49 341 865 252596, karl-patrik.kresoja@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipose tissue inflammation (time frame: Tissue collection during surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2021.