Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2019-11-01
2022-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Adipose and myocardial tissue sampling
After median sternotomy tissue samples will be collected from the epicardial space, the abdominal wall and the myocardium.
Cardiac magnetic resonance imaging
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 testing
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.
Obese controls
No history of heart failure, Left ventricular-EF \> 50% and NT-pro-BNP \<125ng/l, BMI ≥ 30kg/m²
Adipose and myocardial tissue sampling
After median sternotomy tissue samples will be collected from the epicardial space, the abdominal wall and the myocardium.
Cardiac magnetic resonance imaging
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 testing
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.
Lean control
No history of heart failure, Left ventricular-EF \> 50% and NT-pro-BNP \<125ng/l, BMI \< 30kg/m²
Adipose and myocardial tissue sampling
After median sternotomy tissue samples will be collected from the epicardial space, the abdominal wall and the myocardium.
Cardiac magnetic resonance imaging
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 testing
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.
Interventions
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Adipose and myocardial tissue sampling
After median sternotomy tissue samples will be collected from the epicardial space, the abdominal wall and the myocardium.
Cardiac magnetic resonance imaging
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 testing
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.
Eligibility Criteria
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Inclusion Criteria
* Non-HF patients: No history of heart failure, Left ventricular ejection fraction \> 50% and NT-pro-BNP \<125ng/l
Exclusion Criteria
* 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
* Contraindication for magnetic resonance imaging
* Pregnancy
* Age \< 18 years
* No informed consent possible
18 Years
ALL
No
Sponsors
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Heart Center Leipzig - University Hospital
OTHER
Responsible Party
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Philipp Lurz
Clinical Investigator, Professor, Managing Senior Physician
Locations
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Heart Centre at University Leipzig
Leipzig, Saxony, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SLIM-HFpEF V1.0
Identifier Type: -
Identifier Source: org_study_id
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