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

Heart Failure Clinical Trial

— LIPAMUS-HF  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663115
• Other study ID #: U1111-1178-1176
• Status: Completed
• Start date: January 2016

Study information

• Verified date: June 2018
• Source: Heartcenter Leipzig GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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 a antagonists, ß-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

Related Conditions & MeSH terms

• Cardiomyopathies
• Dilatative Myocardiopathy
• Heart Failure
• Ischemic Myocardiopathy

Intervention

Other:
• Biopsy of the diaphragmatic muscle

• Skeletal muscle biopsy

Locations

Country	Name	City	State
Germany	Heart Center Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Norman Mangner

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of catabolic E3 ligase Muscle ring finger 1 (MuRF1)		at the time of index procedure (biopsy)
Secondary	in vitro measurement of the muscle protein - poly ubiquitination of Proteins		at the time of index procedure (biopsy)
Secondary	in vitro measurement of the muscle protein - the proteasome activity		at the time of index procedure (biopsy)
Secondary	in vitro measurement of the muscle protein - fiber typing in the muscle samples		at the time of index procedure (biopsy)
Secondary	in vitro measurement of the force development of skinned muscle fibers		at the time of index procedure (biopsy)