Influence of Severe Heart Failure to Function and Molecular Biological Parameters of Catabolism in the Human Diaphragm and Peripheral Skeletal Muscle

Norman Mangner1 site in 1 country44 target enrollmentJanuary 2016

ConditionsHeart Failure Ischemic Myocardiopathy Dilatative Myocardiopathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Norman Mangner
Enrollment: 44
Locations: 1
Primary Endpoint: Expression of catabolic E3 ligase Muscle ring finger 1 (MuRF1)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Project aim is to quantify the influence of a severe therapy-refractory heart failure caused by ischemic or dilative myocardiopathy on the function of the diaphragm, its molecular biological parameters and on the M. vastus lateralis. The control group consists of patients with coronary artery disease (CAD) and normal left ventricular ejection fraction indicated for coronary artery bypass graft surgery (CABG) Differences in the geneses of heart failure (ischemic vs. dilative cardiomyopathy) will be evaluated during analysis. The ubiquitin-proteasome signaling pathway is considered as a central issue for the mechanism of the analyses muscle catabolism.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

March 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Norman Mangner

Responsible Party

Sponsor Investigator

Principal Investigator

Norman Mangner

Dr. med. Norman Mangner

Heart Center Leipzig - University Hospital

Eligibility Criteria

Inclusion Criteria

•inclusion criteria Group A:
•age 40 - 70 years
•Restricted left ventricular pump function left ventricular ejection fraction (LVEF) \> 35% on the basis of ischemic cardiomyopathy (ICM) and restricted resting cardiac output (CI\> 2.4 L / min / m²)
•or restricted maximal oxygen uptake (VO2max\> 17 ml / min / m²)
•Duration of heart failure\> 1 year
•Maximum of individual heart failure therapy
•Heart team decision to LVAD Implantation
•inclusion criteria Group B:
•age 40 - 70 years
•Restricted left ventricular pump function (LVEF) \> 35% on the basis of dilatative cardiomyopathy (DCM) and restricted resting cardiac output (CI\> 2.4 L / min / m²)

Exclusion Criteria

•Mechanical ventilation within the last 3 months
•Forced Expiratory Pressure (FEV1) \<70% of the norm and / or therapy with α antagonists, β-mimetics or inhaled corticosteroids for the treatment of a lung disease
•Pulmonary fibrosis
•elevated diaphragm in the ultrasound or X-ray diagnosis or known paresis of the phrenic nerve
•chronic kidney disease (CKD) stage 4 and 5, i.e. glomerular filtration rate (GFR) \<30ml / min / 1.73m and / or dialysis
•Acute renal failure
•Treatment with immunosuppressive agents
•Hepatic insufficiency Child-Pugh B and C
•Higher grade ventricular arrhythmias (Lown IV b)
•Acute myocardial infarction (less than three months)

Outcomes

Primary Outcomes

Expression of catabolic E3 ligase Muscle ring finger 1 (MuRF1)

Time Frame: at the time of index procedure (biopsy)

Secondary Outcomes

in vitro measurement of the muscle protein - poly ubiquitination of Proteins(at the time of index procedure (biopsy))
in vitro measurement of the muscle protein - fiber typing in the muscle samples(at the time of index procedure (biopsy))
in vitro measurement of the force development of skinned muscle fibers(at the time of index procedure (biopsy))
in vitro measurement of the muscle protein - the proteasome activity(at the time of index procedure (biopsy))