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Adipose Tissue Inflammation in HFpEF (SLIM-HFpEF)

H

Heart Center Leipzig - University Hospital

Status

Unknown

Conditions

Heart Failure With Preserved Ejection Fraction
Obesity

Treatments

Diagnostic Test: Cardiac magnetic resonance imaging
Diagnostic Test: Adipose and myocardial tissue sampling
Diagnostic Test: Cardiopulmonary exercise testing

Study type

Observational

Funder types

Other

Identifiers

NCT04886713
SLIM-HFpEF V1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Contraindication for magnetic resonance imaging
  • Pregnancy
  • Age < 18 years
  • No informed consent possible

Trial design

30 participants in 3 patient groups

Obese HFpEF
Description:
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
Treatment:
Diagnostic Test: Cardiopulmonary exercise testing
Diagnostic Test: Cardiac magnetic resonance imaging
Diagnostic Test: Adipose and myocardial tissue sampling
Obese controls
Description:
No history of heart failure, Left ventricular-EF \> 50% and NT-pro-BNP \<125ng/l, BMI ≥ 30kg/m²
Treatment:
Diagnostic Test: Cardiopulmonary exercise testing
Diagnostic Test: Cardiac magnetic resonance imaging
Diagnostic Test: Adipose and myocardial tissue sampling
Lean control
Description:
No history of heart failure, Left ventricular-EF \> 50% and NT-pro-BNP \<125ng/l, BMI \< 30kg/m²
Treatment:
Diagnostic Test: Cardiopulmonary exercise testing
Diagnostic Test: Cardiac magnetic resonance imaging
Diagnostic Test: Adipose and myocardial tissue sampling

Trial contacts and locations

1

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Central trial contact

Karl-Patrik Kresoja, MD

Data sourced from clinicaltrials.gov

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