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

June 8, 2018 updated by: Norman Mangner
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany
        • Heart Center Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe therapy-refractory heart failure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Biopsy of the diaphragmatic muscle
Other: Skeletal muscle biopsy
Arm 2
Patients (age 40-70 years) with the indication for elective bypass surgery and normal left ventricular function (EF>50%)
Other: Biopsy of the diaphragmatic muscle
Other: Skeletal muscle biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Expression of catabolic E3 ligase Muscle ring finger 1 (MuRF1)
Time Frame: at the time of index procedure (biopsy)
at the time of index procedure (biopsy)

Secondary Outcome Measures

Outcome Measure
Time Frame
in vitro measurement of the muscle protein - poly ubiquitination of Proteins
Time Frame: at the time of index procedure (biopsy)
at the time of index procedure (biopsy)
in vitro measurement of the muscle protein - the proteasome activity
Time Frame: at the time of index procedure (biopsy)
at the time of index procedure (biopsy)
in vitro measurement of the muscle protein - fiber typing in the muscle samples
Time Frame: at the time of index procedure (biopsy)
at the time of index procedure (biopsy)
in vitro measurement of the force development of skinned muscle fibers
Time Frame: at the time of index procedure (biopsy)
at the time of index procedure (biopsy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norman Mangner

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

June 11, 2018

Last Update Submitted That Met QC Criteria

June 8, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1178-1176

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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