Natural time course of lung function and respiratory muscle strength in patients with optimally treated stable heart failure with reduced ejection fraction

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013902

Enrollment

Registered

2018-03-20

Start date

2018-07-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50.1

Interventions

Group 1: Patients with heart failure with reduced ejection fraction will undergo a comprehensive and unique set of lung function and respiratory muscle strength tests within our lab of respiratory phy

with no abnormal findings in an electrocardiogram, echocardiogram and normal NT-BNP levels) will undergo the study protocol described above.

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); >12 weeks since the diagnosis of HFrEF has been made; no hospitalisation for HF in the last 4 weeks; optimal medical therapy in accordance with the most recent Guidelines of the European Society of Cardiology (ESC) with no change in medication in the last 4 weeks and combination therapy for HFrEF -where there was no treatment with beta blockers or ACE Inhibitors/ARBs in HFrEF, then the reason must be documented- d. Controls (matched for age and gender) with normal findings on echocardiogram, electrocardiogram and normal levels of natriuretic peptide hormone

Exclusion criteria

Exclusion criteria: - Body Mass Index (BMI) > 35 - 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]	—

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 leg muscle strength [kg], -> the above mentioned value will be obtained by means of a dynamometer 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], transdiaphragmatic pressure	—

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 leg muscle strength [kg], -> the above mentioned value will be obtained by means of a dynamometer 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], transdiaphragmatic pressure

—

Countries

Germany

Contacts

Public ContactMatthias Boentert

Department für Neurologie- Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster

matthias.boentert@ukmuenster.de00492518344458

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026