High Flow Oxygen Therapy in Patients with Sleep Apnea and Heart Failure

High-Flow-Therapy for the treatment of Cheyne-Stokes-Respiration in chronic heart failure: A randomized, controlled, cross-over trial - Float-CS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001357-40-DE

Enrollment

Registered

2016-06-28

Start date

2016-11-08

Completion date

Unknown

Last updated

2018-04-30

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

Conditions

Cheyne-Stokes Respiration in chronic heart failure

Interventions

Trade Name: CONOXIA® GO2X Pharmaceutical Form: Medicinal gas, compressed INN or Proposed INN: OXYGEN CAS Number: 7782-44-7 Concentration unit: % percent Concentration number: 100- Pharmaceutical form

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age 18-90 years • New York Heart Association (NYHA) class II to IV • Left ventricular ejection fraction = 45% • Predominantly central sleep apnea (AHI =15 events per hour, with >80% central events [apnea or hypopnea] and a central AHI of =10 events per hour) • Hypoxemic burden = 25% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: • daytime hypercapnia (pCO2 > 45 mmHg) • ongoing ventilation therapy • cardiothoracic surgery within the last 3 months • myocardial infarction within the last 6 months • unstable angina • acute myocarditis • stroke within the last 3 months • epilepsy, known cerebral damage, dementia • untreated restless-legs-syndrome

Design outcomes

Primary

Measure	Time frame
Main Objective: In a proof-of concept-Study we therefore aim to test the hypothesis that high flow therapy attenuates hypoxemic burden in patients with heart failure with reduced ejection fraction. Primary study endpoint: Reduction of hypoxemic burden >50% compared to baseline using HFT versus sham-HFT ;Secondary Objective: Changes in parameters regarding sleep, hemodynamics and cardiorespiratory function compared to baseline using HFT versus sham-HFT;Primary end point(s): Reduction of hypoxemic burden >50% compared to baseline using HFT versus sham-HFT;Timepoint(s) of evaluation of this end point: After 1 night of sleep	—

Measure

Time frame

Main Objective: In a proof-of concept-Study we therefore aim to test the hypothesis that high flow therapy attenuates hypoxemic burden in patients with heart failure with reduced ejection fraction. Primary study endpoint: Reduction of hypoxemic burden >50% compared to baseline using HFT versus sham-HFT ;Secondary Objective: Changes in parameters regarding sleep, hemodynamics and cardiorespiratory function compared to baseline using HFT versus sham-HFT;Primary end point(s): Reduction of hypoxemic burden >50% compared to baseline using HFT versus sham-HFT;Timepoint(s) of evaluation of this end point: After 1 night of sleep

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Secondary

Measure	Time frame
Secondary end point(s): Changes in parameters listed below compared to baseline using HFT versus sham-HFT: time in bed, min total sleep time, min sleep latency, min latency to S3, min S1 stadium/total sleep time, % S2 stadium/total sleep time, % S3 stadium/total sleep time, % REM sleep/total sleep time, % arousals/total sleep time, n respiratory arousals/total sleep time, n desaturation arousals/total sleep time, n average systolic blood pressure, mmHg average diastolic blood pressure, mmHg longest apnoea, s longest hypopnoea, s obstructive apnoea, h-1 mixed apnoea, h-1 central apnoea, h-1 obstructive hypopnoea, h-1 central hypopnoea, h-1 apnoea+hypopnoea total, h-1 desaturations, h-1 mean sO2, % lowest sO2, % mean desaturation, % cycle length, s ventilation length, s apnea length, s circulatory delay, s time to peak ventilation, s BNP, ng/ml HS Troponin T, pg/ml PaO2, mmHg PaCO2, mmHg sO2, % HCO3, mmol/l ABE, mmol/l pH transcutaneously measured pCO2, mmHg Cardiac output (CO) Cardiac index (CI) Stroke volume (SV) Stroke volume index (SVI) Stroke volume variation (SVV) Systemic vascular resistence (SVR) Systemic vascular resistence index (SVRI) ;Timepoint(s) of evaluation of this end point: After 1 night of sleep	—

Measure

Time frame

Secondary end point(s): Changes in parameters listed below compared to baseline using HFT versus sham-HFT: time in bed, min total sleep time, min sleep latency, min latency to S3, min S1 stadium/total sleep time, % S2 stadium/total sleep time, % S3 stadium/total sleep time, % REM sleep/total sleep time, % arousals/total sleep time, n respiratory arousals/total sleep time, n desaturation arousals/total sleep time, n average systolic blood pressure, mmHg average diastolic blood pressure, mmHg longest apnoea, s longest hypopnoea, s obstructive apnoea, h-1 mixed apnoea, h-1 central apnoea, h-1 obstructive hypopnoea, h-1 central hypopnoea, h-1 apnoea+hypopnoea total, h-1 desaturations, h-1 mean sO2, % lowest sO2, % mean desaturation, % cycle length, s ventilation length, s apnea length, s circulatory delay, s time to peak ventilation, s BNP, ng/ml HS Troponin T, pg/ml PaO2, mmHg PaCO2, mmHg sO2, % HCO3, mmol/l ABE, mmol/l pH transcutaneously measured pCO2, mmHg Cardiac output (CO) Cardiac index (CI) Stroke volume (SV) Stroke volume index (SVI) Stroke volume variation (SVV) Systemic vascular resistence (SVR) Systemic vascular resistence index (SVRI) ;Timepoint(s) of evaluation of this end point: After 1 night of sleep

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Countries

Germany

Contacts

Public ContactWissenschaftliches Sekretariat

Klinik für Kardiologie, Herz- und Diabeteszentrum NRW

akleemeyer@hdz-nrw.de495731971258

Outcome results

None listed

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