Heart Failure (HF)NCT02301689
SchlaHF-XT-Register. Sleep Disordered Breathing in Heart Failure Register
An observational study of Heart Failure (HF), run by ResMed at 1 site in Germany.
Trial summary
The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The study aims to understand the importance of diagnosis and treatment of sleep disordered breathing (SDB) on HF with the following questions: How often does SDB occur in HF? What forms of SDB occur and how are they treated? How does… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure (HF)
- How many people
- 4,749 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Jun 2018
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is patients with Heart failure (HF). HF is defined as a symptom complex of shortness of breath and rapid fatigability on the basis of cardiac disease (World Health Organisation).
Who may be able to join
- diagnose chronic heart failure, at least 3 months prior to diagnosis
- Age 18 years
- Signed informed consent
Who cannot join
- Existing Positive Airway Pressure (PAP) therapy or long-term oxygen therapy
- Lack of capacity to consent
- minors
- persons who are housed on judicial or administrative order in an institution
- pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heart and Diabetes Centre
Bad Oeynhausen, North Rhine-Westphalia, 32545
About this study
Official title: SchlaHF-XF- Register. Sleep Disordered Breathing in Heart Failure Register
The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The study aims to understand the importance of diagnosis and treatment of sleep disordered breathing (SDB) on HF with the following questions:
How often does SDB occur in HF? What forms of SDB occur and how are they treated? How does SDB develop over time? How does the heart failure therapy affect SDB? What is the treatment adherence of patients treated? Does SBD and its treatment affect the survival of heart failure patients?
- Conditions
- Heart Failure (HF)
- Keywords
- Heart failure, Chronic heart failure, Sleep disordered breathing, Sleep apnea, Positive Airway Pressure
- Medical subject headings
- Heart Failure, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of heart failure patients with sleep disordered breathing (apnea hypopnoea index >5)
Assess the changes in prevalence of SDB in HF from baseline to 5 years
Measured: 5 years
Secondary outcomes (4)
Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to sleep disordered breathing treatment
Assess changes in sleep disordered breathing when exposed to treatment from baseline to 5 years
Measured: 5 years
Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to Heart Failure treatment
Assess changes in SDB when the patient is treated with heart failure therapy
Measured: 5 years
Number of patients adherent to sleep disordered breathing treatment as measured by device reported usage hours
Assess adherence rates to treatment
Measured: 5 years
Number of deaths of patients with HF and sleep disordered breathing (apnea hypopnoea index >5) who are treated for sleep disordered breathing
Assess survival rates of HF patients who are treated for sleep disordered breathing
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure (HF)Studies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,749 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olaf Oldenburg, MD, Principal investigator, Heart and Diabetes Centre NRW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301689
- Sponsor's protocol ID
- MA120814
- Status last verified
- Apr 2020
- First submitted
- 17 Sep 2014
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Arzt M, Oldenburg O, Graml A, Schnepf J, Erdmann E, Teschler H, Schoebel C, Woehrle H; SchlaHF-XT investigators. Prevalence and predictors of sleep-disordered breathing in chronic heart failure: the SchlaHF-XT registry. ESC Heart Fail. 2022 Dec;9(6):4100-4111. doi: 10.1002/ehf2.14027. Epub 2022 Sep 2.
PubMed 36052740
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SchlaHF-XF- Register. Sleep Disordered Breathing in Heart Failure Register
- ClinicalTrials.gov ID
- NCT02301689
- Acronym / sponsor ID
- MA120814
- Conditions
- Heart Failure (HF)
- Keywords
- Heart failure, Chronic heart failure, Sleep disordered breathing, Sleep apnea, Positive Airway Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,749 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The study aims to understand the importance of diagnosis and treatment of sleep disordered breathing (SDB) on HF with the following questions:
How often does SDB occur in HF? What forms of SDB occur and how are they treated? How does SDB develop over time? How does the heart failure therapy affect SDB? What is the treatment adherence of patients treated? Does SBD and its treatment affect the survival of heart failure patients?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is patients with Heart failure (HF). HF is defined as a symptom complex of shortness of breath and rapid fatigability on the basis of cardiac disease (World Health Organisation).
Key inclusion criteria (3 listed)
- diagnose chronic heart failure, at least 3 months prior to diagnosis
- Age 18 years
- Signed informed consent
Key exclusion criteria (5 listed)
- Existing Positive Airway Pressure (PAP) therapy or long-term oxygen therapy
- Lack of capacity to consent
- minors
- persons who are housed on judicial or administrative order in an institution
- pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of heart failure patients with sleep disordered breathing (apnea hypopnoea index >5)
Time frame: 5 years
Assess the changes in prevalence of SDB in HF from baseline to 5 years
4 secondary outcomes
Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to sleep disordered breathing treatment
Time frame: 5 years
Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to Heart Failure treatment
Time frame: 5 years
Number of patients adherent to sleep disordered breathing treatment as measured by device reported usage hours
Time frame: 5 years
Number of deaths of patients with HF and sleep disordered breathing (apnea hypopnoea index >5) who are treated for sleep disordered breathing
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Derived from this study: PubMed 36052740Arzt M, Oldenburg O, Graml A, Schnepf J, Erdmann E, Teschler H, Schoebel C, Woehrle H; SchlaHF-XT investigators. Prevalence and predictors of sleep-disordered breathing in chronic heart failure: the SchlaHF-XT registry. ESC Heart Fail. 2022 Dec;9(6):4100-4111. doi: 10.1002/ehf2.14027. Epub 2022 Sep 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olaf Oldenburg, MD principal investigator
Heart and Diabetes Centre NRW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure (HF), run by ResMed at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of heart failure patients with sleep disordered breathing (apnea hypopnoea index >5) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.