Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

High-Flow-Therapy for the Treatment of Cheyne-Stokes-Respiration in Chronic Heart Failure (FLOAT-CS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102827
Recruitment Status : Terminated (Unavailability of PI and Deputy)
First Posted : April 6, 2017
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Bitter, Heart and Diabetes Center North-Rhine Westfalia

Brief Summary:
To demonstrate the effectiveness and safety of nocturnal ventilation with oxygen (HFT - high-flow-therapy) for the treatment of CSA in patients with HFrEF compared to placebo (patient will breathe ambient air via nasal cannula that is not connected to the high-flow-device).

Condition or disease Intervention/treatment Phase
Heart Failure,Congestive Drug: Oxygen Other: Placebo Phase 3

Show Show detailed description

Layout table for study information
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

Resource links provided by the National Library of Medicine


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
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
Other: Placebo
Ambient air without high-flow therapy administered during first night
Other Name: Ambient air




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Germany
Heart and Diabetes Center North-Rhine-Westphalia
Bad Oeynhausen, Germany, 32545
Sponsors and Collaborators
Heart and Diabetes Center North-Rhine Westfalia
Investigators
Layout table for investigator information
Principal Investigator: Thomas Bitter, MD Heart and Diabetes Center North Rhine-Westphalia
Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cheyne-Stokes Respiration
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory