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Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry (SchlaHF)

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: NCT01500759
Recruitment Status : Completed
First Posted : December 28, 2011
Results First Posted : July 9, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
ResMed

Brief Summary:

Objective target of the registry is to investigate the prevalence of SDB as well as the clinical characteristics of patients with and without SDB as well as the predominant type of sdb.

For this purpose data from patients suffering from chronic, symptomatic heart failure with impaired left ventricular ejection fraction will be collected prospectively.


Condition or disease
Congestive Heart Failure Left Ventricular Systolic Dysfunction

Detailed Description:

Despite recent advances in pharmacological treatment, congestive heart failure (CHF) continues to cause debilitating symptoms, frequent hospital admissions and a high mortality. Despite of therapy with beta-blockers and ACE-inhibitors many patients have persistent symptoms and most will eventually die of cardiovascular causes, often from progressive heart failure.

Sleep Disordered Breathing (SDB) is known to cause consequences, which have negative effects on heart failure.

Objective target of the registry is to investigate the prevalence of SDB, clinical characteristics, symptoms and the degree and type of SDB in patients with chronic HF.

For this purpose data from patients with chronic heart failure will be collected prospectively.In the registry several cardiologists in private practice or hospital and cooperating sleep laboratories shall participate.

Cardiologists screen patients with Chronic Heart Failure (chronic HF) prospectively. In case of suffering from chronic HF for at least 12 weeks since diagnosis, with NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 12 months. Written informed consent for data privacy aspects must be obtained before screening for SDB. Patients who satisfy to all inclusion- and exclusion criteria will be included consecutively into the registry.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 6876 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure
Study Start Date : November 2007
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. Prevalence of SDB in Chronic HF Patients [ Time Frame: 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility ]
    SDB= Sleep disordered breathing; HF= Heart failure


Secondary Outcome Measures :
  1. Left Ventricular Ejection Fraction [ Time Frame: 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution ]
    Amount of blood in the left ventricle at the end of Diastole that is being pumped into the System during systole

  2. Age [ Time Frame: 1-time single assessment at baseline ]
    Age years

  3. Body Mass Index [ Time Frame: 1-time single assessment at baseline ]
  4. Male Gender [ Time Frame: 1-time single assessment at baseline ]
  5. NYHA Class ≥III [ Time Frame: At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records ]
    New York Heart Association Class III: Marked Limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in undue breathlessness, fatigue or palpitations.

  6. Ischemic Etiology [ Time Frame: 1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records. ]
    Ischemic etiology describes a condition where a weakening or disease of the heart muscle is caused by reduced supply of blood (underlying cause might be the coronary artery). Secondary outcome ischemic etiology describes the cause of heart failure (HF) "ischemic" in HF patients without and with sleep-disordered breathing in percent of the respective study arm/group: e.g. x% of patients without SDB have HF with an ischemic etiology.

  7. Atrial Fibrillation [ Time Frame: 1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records ]
  8. Nocturnal Dyspnea [ Time Frame: 1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records ]
  9. Nocturia ≥3 Times/Night [ Time Frame: 1-time: At baseline nocturia was assessed 1 time (anamnesis) ]
  10. Apnoea-Hypopnea-Index [ Time Frame: 1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility ]
    Number of Apnoeas (cessation of airflow for at least 10 seconds) and hypopneas (reduced airflow for at least 10 seconds) per hours of sleep

  11. Oxygen Desaturation Index [ Time Frame: 1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility ]
    Number of times that arterial blood oxygen saturation Drops by ≥3% from the Basic value.

  12. Mean SpO2 [ Time Frame: 1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility ]
    Saturation of oxygen

  13. Min SpO2 [ Time Frame: 1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility ]
    Lowest Saturation with oxygen

  14. Medication ACE Inhibitors and/ARBs [ Time Frame: 1-time: At baseline medication was assessed 1 time (anamnesis) ]
    ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker

  15. Beta-blocker [ Time Frame: 1-time: At baseline medication was assessed 1 time (anamnesis) ]
  16. Diuretics [ Time Frame: 1-time: At baseline medication was assessed 1 time (anamnesis) ]
  17. Digitalis [ Time Frame: 1-time: At baseline medication was assessed 1 time (anamnesis) ]
  18. Aldosterone Antagonists [ Time Frame: 1-time: At baseline medication was assessed 1 time (anamnesis) ]
  19. Male Gender as Predictor for SDB in Chronic HF [ Time Frame: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) ]
    From the total number of participants, the number of male patients without and with SDB were counted and an odds Ratio for male sex as predictor for SDB in chronic heart failure

  20. Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF [ Time Frame: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) ]
    From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for AF as predictor for SDB in chronic heart failure

  21. Ischemic Etiology as Predictor for SDB in Chronic HF [ Time Frame: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) ]
    From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for ischemic etiology as predictor for SDB in chronic heart failure

  22. NYHA Class >= III as Predictor for SDB in Chronic HF [ Time Frame: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records) ]
    From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for NYHA (New York Heart Association - class I not impaired, class II slighly impaired, class III severly impaired, class IV = unable to perform normal tasks) class≥III as predictor for SDB in chronic heart failure



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
Adult patients with Chronic Heart Failure with LVEF ≤ 45% and NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 24 months.
Criteria

Inclusion Criteria:

  • Patients must be over 18
  • Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines
  • Left ventricular systolic dysfunction (LVEF ≤ 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks
  • NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months
  • Patient is able to fully understand study information and signed informed consent

Exclusion Criteria:

  • Life expectancy < 1 year for diseases unrelated to chronic HF
  • Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months
  • CRT-implantation (either CRT-D or CRT-P) scheduled or within 6 months
  • Transient ischemic attack (TIA) or Stroke within 3 months
  • Hemodynamically significant uncorrected primary valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery
  • Acute myocarditis/pericarditis within 6 months
  • Current CPAP or bilevel therapy

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): NCT01500759


Locations
Show Show 199 study locations
Sponsors and Collaborators
ResMed
Investigators
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Principal Investigator: Erland Erdmann, Prof Klinikum der Universität zu Köln
Principal Investigator: Helmut Teschler, Prof Ruhrlandklinik Essen
Study Director: Holger Woehrle, MD ResMed
Additional Information:

Publications of Results:
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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01500759    
Other Study ID Numbers: 001
First Posted: December 28, 2011    Key Record Dates
Results First Posted: July 9, 2020
Last Update Posted: July 9, 2020
Last Verified: May 2020
Keywords provided by ResMed:
chronic heart failure
heart failure
hf
sleep-disordered breathing
sdb
nyha
lvef
cheyne stokes
central sleep apnoea
sleep apnoea
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