High-Flow-Therapy for the Treatment of Cheyne-Stokes-Respiration in Chronic Heart Failure

NCT03102827 | Terminated Phase 3

• 1 other identifier: HDZNRW-KA_006-TB
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure，Congestive

Outcome Measures

Primary Outcomes (1)

• Reduction of hypoxemic burden

  Reduction of hypoxemic burden \>50% compared to baseline using oxygen-HFT versus placebo

  From date of enrolment until end of therapy phase (day 3). Hypoxemic burden is determined several times during this period.

Study Arms (2)

Oxygen - ambient air

ACTIVE COMPARATOR

high-flow oxygen therapy administered during first night, ambient air without high-flow therapy (placebo) administered during second night

Drug: Oxygen

Ambient air - oxygen

PLACEBO COMPARATOR

Ambient air without high-flow therapy (placebo) administered during first night , high-flow oxygen therapy administered during second night

Other: Placebo

Interventions

Oxygen DRUG

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.

Also known as: CONOXIA® GO2X

Oxygen - ambient air

Placebo OTHER

Ambient air without high-flow therapy administered during first night

Also known as: Ambient air

Ambient air - oxygen

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Heart and Diabetes Center North-Rhine-Westphalia

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Oxygen; Particulate Matter

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases; Complex Mixtures

Study Officials

• Thomas Bitter, MD

  Heart and Diabetes Center North Rhine-Westphalia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 6, 2017
• Study Start: February 2, 2017
• Primary Completion: March 27, 2018
• Study Completion: March 27, 2018
• Last Updated: September 26, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)