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SchlaHF-XT-Register. Sleep Disordered Breathing in Heart Failure Register

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ClinicalTrials.gov Identifier: NCT02301689
Recruitment Status : Active, not recruiting
First Posted : November 26, 2014
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
ResMed

Brief 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 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?


Condition or disease
Heart Failure (HF)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 4749 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: SchlaHF-XF- Register. Sleep Disordered Breathing in Heart Failure Register
Study Start Date : May 2014
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort
Heart Failure patients



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to sleep disordered breathing treatment [ Time Frame: 5 years ]
    Assess changes in sleep disordered breathing when exposed to treatment from baseline to 5 years

  2. Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to Heart Failure treatment [ Time Frame: 5 years ]
    Assess changes in SDB when the patient is treated with heart failure therapy

  3. Number of patients adherent to sleep disordered breathing treatment as measured by device reported usage hours [ Time Frame: 5 years ]
    Assess adherence rates to treatment

  4. 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 ]
    Assess survival rates of HF patients who are treated for sleep disordered breathing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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).
Criteria

Inclusion Criteria:

  • diagnose chronic heart failure, at least 3 months prior to diagnosis
  • Age 18 years
  • Signed informed consent

Exclusion Criteria:

  • 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

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): NCT02301689


Locations
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Germany
Heart and Diabetes Centre
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Sponsors and Collaborators
ResMed
Investigators
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Principal Investigator: Olaf Oldenburg, MD Heart and Diabetes Centre NRW

Additional Information:

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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT02301689     History of Changes
Other Study ID Numbers: MA120814
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: October 2016
Keywords provided by ResMed:
Heart failure
Chronic heart failure
Sleep disordered breathing
Sleep apnea
Positive Airway Pressure
Additional relevant MeSH terms:
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Respiratory Aspiration
Sleep Apnea Syndromes
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases