High-Flow-Therapy for the Treatment of Cheyne-Stokes-Respiration in Chronic Heart Failure (FLOAT-CS)
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ClinicalTrials.gov Identifier: NCT03102827 |
Recruitment Status :
Terminated
(Unavailability of PI and Deputy)
First Posted : April 6, 2017
Last Update Posted : September 26, 2018
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Condition or disease | Intervention/treatment | Phase |
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Heart Failure,Congestive | Drug: Oxygen Other: Placebo | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | High-Flow-Therapy for the Treatment of Cheyne-Stokes-Respiration in Chronic Heart Failure |
Actual Study Start Date : | February 2, 2017 |
Actual Primary Completion Date : | March 27, 2018 |
Actual Study Completion Date : | March 27, 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Oxygen - ambient air
high-flow oxygen therapy administered during first night, ambient air without high-flow therapy (placebo) administered during second night
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Drug: Oxygen
Patients will receive oxygen with humidified air, fully saturated at 37° C at a flow rate of 20- 50 L/min. The ratio of oxygen and ambient air (FiO2) will be increased stepwise depending on patient's oxygen saturation.
Other Name: CONOXIA® GO2X |
Placebo Comparator: Ambient air - oxygen
Ambient air without high-flow therapy (placebo) administered during first night , high-flow oxygen therapy administered during second night
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Other: Placebo
Ambient air without high-flow therapy administered during first night
Other Name: Ambient air |
- Reduction of hypoxemic burden [ Time Frame: From date of enrolment until end of therapy phase (day 3). Hypoxemic burden is determined several times during this period. ]Reduction of hypoxemic burden >50% compared to baseline using oxygen-HFT versus placebo

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- NYHA II to IV
- LVEF <= 45% (Echo within 28 days of enrollment)
- Predominantly central sleep apnea: AHI ≥15 events per hour, with >80% central events (apnoea or hypopnoea) and central AHI of ≥10 events per hour
- Peak VO2 < 90% of predicted value (CPX test within 28 days of enrollment) Nocturnal hypoxemic burden ≥ 25min/night
- Written informed consent
Exclusion criteria:
- Daytime hypercapnia (pCO2 > 45 mmHg)
- Ongoing ventilation therapy
- Severe COPD (chronic obstructive pulmonary disease) defined as FEV1< 50% (lung function test within 28 days of enrollment)
- 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 or known cerebral damage or dementia
- Untreated restless-legs-syndrome
- Women of childbearing potential
- Participation in any clinical study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102827
Germany | |
Heart and Diabetes Center North-Rhine-Westphalia | |
Bad Oeynhausen, Germany, 32545 |
Principal Investigator: | Thomas Bitter, MD | Heart and Diabetes Center North Rhine-Westphalia |
Responsible Party: | Thomas Bitter, Senior physician, Heart and Diabetes Center North-Rhine Westfalia |
ClinicalTrials.gov Identifier: | NCT03102827 |
Other Study ID Numbers: |
HDZNRW-KA_006-TB |
First Posted: | April 6, 2017 Key Record Dates |
Last Update Posted: | September 26, 2018 |
Last Verified: | September 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cheyne-Stokes Respiration Heart Failure Heart Diseases Cardiovascular Diseases |
Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |