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Clinical Trials/NCT04886713
NCT04886713
Unknown
Not Applicable

Adipose Tissue Inflammation in the Development, Maintenance and Functional Impairments in Heart Failure With Preserved Ejection Fraction

Heart Center Leipzig - University Hospital1 site in 1 country30 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure With Preserved Ejection Fraction
Sponsor
Heart Center Leipzig - University Hospital
Enrollment
30
Locations
1
Primary Endpoint
Adipose tissue inflammation
Last Updated
4 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
March 15, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Heart Center Leipzig - University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Philipp Lurz

Clinical Investigator, Professor, Managing Senior Physician

Heart Center Leipzig - University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Adipose tissue inflammation

Time Frame: Tissue collection during surgery.

Adipose tissue inflammation and distribution as well as association with adipokines

Secondary Outcomes

  • Cardiac MRI - Epicardial fat(At baseline, before surgery.)
  • Cardiac MRI - Myocardial function(At baseline, before surgery.)
  • Echocardiography(At baseline, before surgery and at follow-up approximately three months after surgery.)
  • Stress echocardiography(At follow-up approximately three months after surgery.)
  • Evaluation of serum adipokine levels(At baseline, before surgery.)
  • Functional capacity on spiroergometry(At follow-up approximately three months after surgery.)

Study Sites (1)

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