Heart FailureLIPAMUS-HFNCT02663115
Influence of Severe Heart Failure to Function and Molecular Biological Parameters of Catabolism in the Human Diaphragm and Peripheral Skeletal Muscle
An observational study of Heart Failure and Ischemic Myocardiopathy, run by Norman Mangner at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Heart Failure, Ischemic Myocardiopathy, Dilatative Myocardiopathy
- What is being tested?
- Biopsy of the diaphragmatic muscle and Skeletal muscle biopsy
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe therapy-refractory heart failure
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Biopsy of the diaphragmatic muscle, Skeletal muscle biopsy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of the diaphragmatic muscleOther
Skeletal muscle biopsyOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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%) Receives: Other: Biopsy of the diaphragmatic muscle; Other: Skeletal muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of catabolic E3 ligase Muscle ring finger 1 (MuRF1)
Measured: at the time of index procedure (biopsy)
Secondary outcomes (4)
in vitro measurement of the muscle protein - poly ubiquitination of Proteins
Measured: at the time of index procedure (biopsy)
in vitro measurement of the muscle protein - the proteasome activity
Measured: at the time of index procedure (biopsy)
in vitro measurement of the muscle protein - fiber typing in the muscle samples
Measured: at the time of index procedure (biopsy)
in vitro measurement of the force development of skinned muscle fibers
Measured: at the time of index procedure (biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norman Mangner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Norman Mangner, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663115
- Sponsor's protocol ID
- U1111-1178-1176
- Acronym
- LIPAMUS-HF
- Status last verified
- Jun 2018
- First submitted
- 15 Jan 2016
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mangner N, Garbade J, Heyne E, van den Berg M, Winzer EB, Hommel J, Sandri M, Jozwiak-Nozdrzykowska J, Meyer AL, Lehmann S, Schmitz C, Malfatti E, Schwarzer M, Ottenheijm CAC, Bowen TS, Linke A, Adams V. Molecular Mechanisms of Diaphragm Myopathy in Humans With Severe Heart Failure. Circ Res. 2021 Mar 19;128(6):706-719. doi: 10.1161/CIRCRESAHA.120.318060. Epub 2021 Feb 4.
PubMed 33535772
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Severe Heart Failure to Function and Molecular Biological Parameters of Catabolism in the Human Diaphragm and Peripheral Skeletal Muscle
- ClinicalTrials.gov ID
- NCT02663115
- Acronym / sponsor ID
- LIPAMUS-HF / U1111-1178-1176
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Norman MangnerUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2018 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Other: Biopsy of the diaphragmatic muscle, Other: Skeletal muscle biopsyPatients (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 |
| Arm 2 | – | Other: Biopsy of the diaphragmatic muscle, Other: Skeletal muscle biopsyPatients (age 40-70 years) with the indication for elective bypass surgery and normal left ventricular function (EF>50%) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe therapy-refractory heart failure
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy of the diaphragmatic muscle | Other | Arm 1, Arm 2 |
| Skeletal muscle biopsy | Other | Arm 1, Arm 2 |
Primary outcome
Expression of catabolic E3 ligase Muscle ring finger 1 (MuRF1)
Time frame: at the time of index procedure (biopsy)
4 secondary outcomes
in vitro measurement of the muscle protein - poly ubiquitination of Proteins
Time frame: 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)
in vitro measurement of the muscle protein - fiber typing in the muscle samples
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Derived from this study: PubMed 33535772Mangner N, Garbade J, Heyne E, van den Berg M, Winzer EB, Hommel J, Sandri M, Jozwiak-Nozdrzykowska J, Meyer AL, Lehmann S, Schmitz C, Malfatti E, Schwarzer M, Ottenheijm CAC, Bowen TS, Linke A, Adams V. Molecular Mechanisms of Diaphragm Myopathy in Humans With Severe Heart Failure. Circ Res. 2021 Mar 19;128(6):706-719. doi: 10.1161/CIRCRESAHA.120.318060. Epub 2021 Feb 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Ischemic Myocardiopathy, run by Norman Mangner at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of catabolic E3 ligase Muscle ring finger 1 (MuRF1) (time frame: at the time of index procedure (biopsy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02663115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.