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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02663115
Acronym
LIPAMUS-HF
Enrollment
44
Registered
2016-01-26
Start date
2016-01-31
Completion date
Unknown
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Ischemic Myocardiopathy, Dilatative Myocardiopathy

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.

Interventions

OTHERBiopsy of the diaphragmatic muscle

Sponsors

Norman Mangner
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Expression of catabolic E3 ligase Muscle ring finger 1 (MuRF1)at the time of index procedure (biopsy)

Secondary

MeasureTime frame
in vitro measurement of the muscle protein - poly ubiquitination of Proteinsat the time of index procedure (biopsy)
in vitro measurement of the muscle protein - the proteasome activityat the time of index procedure (biopsy)
in vitro measurement of the muscle protein - fiber typing in the muscle samplesat the time of index procedure (biopsy)
in vitro measurement of the force development of skinned muscle fibersat the time of index procedure (biopsy)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026