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Completed

NCT Number: NCT02663115

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

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Dilatative Myocardiopathy Heart Diseases Ischemic Myocardiopathy

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center Leipzig

Leipzig, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy of the diaphragmatic muscle

Other

Skeletal muscle biopsy

Other

Primary outcomes

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

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

Secondary outcomes

  1. in vitro measurement of the muscle protein - poly ubiquitination of Proteins

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

  2. in vitro measurement of the muscle protein - the proteasome activity

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

  3. in vitro measurement of the muscle protein - fiber typing in the muscle samples

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

  4. in vitro measurement of the force development of skinned muscle fibers

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

Sponsors and collaborators

Lead sponsor

Norman Mangner

Other

Registry information

Acronym: LIPAMUS-HF

Important dates

Study start
2016
Primary completion
2018
First posted
Jan 26, 2016
Registry last updated
Jun 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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