TerminatedPhase 3

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

Stopped: Unavailability of PI and Deputy

Germany14 participantsStarted 2017-02-02

Plain-language 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).

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction of hypoxemic burden

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

Trial details

NCT IDNCT03102827

SponsorHeart and Diabetes Center North-Rhine Westfalia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-27

View on ClinicalTrials.gov More Heart Failure，Congestive trials

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.