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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure Ischemic Myocardiopathy Dilatative Myocardiopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm 1

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

Biopsy of the diaphragmatic muscle

Intervention Type OTHER

Skeletal muscle biopsy

Intervention Type OTHER

Arm 2

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

Biopsy of the diaphragmatic muscle

Intervention Type OTHER

Skeletal muscle biopsy

Intervention Type OTHER

Interventions

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Biopsy of the diaphragmatic muscle

Intervention Type OTHER

Skeletal muscle biopsy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No