Influence of Severe Heart Failure to Function and Molecular Biological Parameters of Catabolism in the Human Diaphragm and Peripheral Skeletal Muscle (LIPAMUS-HF)

Norman Mangner

Status: Completed

Conditions: Heart Failure; Ischemic Myocardiopathy; Dilatative Myocardiopathy

Treatments: Other: Biopsy of the diaphragmatic muscle; Other: Skeletal muscle biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT02663115

U1111-1178-1176

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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)
• 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 C:

• age 40 - 70 years
• coronary heart disease with indication for elective, coronary artery bypass surgery
• normal left ventricle (LV) pumping function LVEF> 50%
• stable clinical situation (no cardiac decompensation within the last 6 months)

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)
• Decompensated Vitium cordis
• Age <40 years and> 70 years
• Pregnancy

Trial design

44 participants in 2 patient groups

Arm 1

Description:

Patients (age 40 - 70 years) with severe therapy-refractory heart failure caused by ischemic or dilatative myocardiopathy with indication for left ventricular assist device (LVAD) therapy

Treatment:

Other: Biopsy of the diaphragmatic muscle

Other: Skeletal muscle biopsy

Arm 2

Description:

Patients (age 40-70 years) with the indication for elective bypass surgery and normal left ventricular function (EF\>50%)

Treatment:

Other: Biopsy of the diaphragmatic muscle

Other: Skeletal muscle biopsy