I50.1
Conditions
Interventions
Group 1: Patients with newly diagnosed HFrEF will undergo a comprehensive and unique set of lung function and respiratory muscle strength tests within our lab of respiratory physiology.
This will be d
with no abnormal findings in an electrocardiogram, echocardiogram and normal NT-BNP levels) will undergo the study protocol once.
Sponsors
Department für Neurologie - Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: a. Age > 18 years (no age limit) b. able to consent c. Diagnosis of heart failure with reduced ejection fraction -HFrEF- according to the most recent Guidelines of the European Society of Cardiology (ESC); < 4 weeks since the diagnosis of HFrEF with < 4 weeks since optimal medical therapy in accordance with the most recent Guidelines of the European Society of Cardiology (ESC) was initiated d. healthy controls (matched for age and gender) with normal findings on echocardiogram, electrocardiogram and normal levels of natriuretic peptide hormone Additional inclusion criterion for post-treatment evaluation: -Positive treatment response as reflected by clinical improvement (NYHA I or II) and/or improvement in left ventricular ejection fraction on echocardiogram - where there was no treatment with with beta blockers or ACE Inhibitors/ARBs in HFrEF, then the reason must be documented
Exclusion criteria
Exclusion criteria: - Body Mass Index (BMI) > 35 - Heart failure with left ventricular ejection fraction > 50% - Chronic obstructive pulmonary disease, emphysema - Presence of severe neurological comorbidities especially primary myopathy, muscular dystrophy, motor neuron disease, phrenic nerve disease, epilepsy, multiple sclerosis, parkinson’s disease - Severe psychiatric disease including dementia - Thoracic wall disease - Cardiac pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Twitch transdiaphragmatic pressure after magnetic cervical stimulation of the phrenic nerves [cmH2O; measured through intraosophageal and intragastral balloon catheters with pressure recordings in response to bilateral, supramaximal cervical magnetic stimulation] -> Measurements will be obtained prior to and after drug therapy has been established for 3-6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue Severity Scale [points], quality of life using SF-36 [points], six-minute walk distance (6 MWD) [m], Medical Research Council Dyspnoea Scale [points], Borg Dyspnoea Scale pre and post 6 MWD [points], -> the above mentioned values will be obtained by means of questionaires fist muscle strength [kg], leg muscle strength [kg], -> the above mentioned values will be obtained by means of dynamometers Forced vital capacity [ml], FEV1/FVC [%], MIP [cmH2O], MEP [cmH2O], SNIP [cmH2O], peak cough Flow [L/sek], -> the above mentioned values will be obtained by means of spirometry devices Rate of rise of diaphramatic amplitude during tidal breathing on ultrasound [cm/sec], Rate of rise of diaphramatic amplitude during Sniff maneuver on ultrasound, Rate of rise of diaphramatic amplitude during maximal inspiration on ultrasound, diaphragm thickness after maximal inspiration on ultrasound [cm], diaphragm thickness after maximal exspiration on ultrasound, diaphragm thickness after tidal breathing on ultrasound [cm], thickening ratio [n.u.], -> the above mentioned values will be obtained by means of diaphragm ultrasound, twitch mouth pressure after magnetic cervical stimulation of the phrenic nerves [cmH2O], twitch mouth pressure after magnetic cortical stimulation of the phrenic nerves [cmH2O], twitch transdiaphragmatic pressure after magnetic cortical stimulation of the phrenic nerves [cmH2O], twitch gastric pressure after thoracic magnetic stimulation of the (expiratory) abdominal muscles [cmH2O] twitch mouth pressure after thoracic magnetic stimulation of the (expiratory) abdominal muscles [cmH2O] phrenic nerve conduction time after cortical magentic stimulation [ms], phrenic nerve conduction time after cervical magentic stimulation [ms], Amplitude of compound diaphragm muscle action potential after cortical magentic stimulation [mA], Amplitude of compound diaphragm muscle action potential after cervical magnetic stimulation [mA], central motor conduction time [ms], | — |
Countries
Germany
Contacts
Public ContactMatthias Boentert
Department für Neurologie- Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
Outcome results
None listed