ung function and respiratory muscle strength in patients with newly diagnosed heart failure with reduced ejection fraction before and after initiation of optimal medical therapy

Conditions: I50.1
Left ventricular failure

Registration Number: DRKS00013901

Lead Sponsor: Department für Neurologie - Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting stopped after recruiting started

Sex: All

Target Recruitment: 2

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

- 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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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]<br>-> Measurements will be obtained prior to and after drug therapy has been established for 3-6 months

Secondary Outcome Measures