Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure

This study has been terminated.
(Poor enrollment)
Sponsor:
Information provided by (Responsible Party):
Steve Gottlieb, University of Maryland
ClinicalTrials.gov Identifier:
NCT01431157
First received: September 7, 2011
Last updated: December 9, 2013
Last verified: December 2013

September 7, 2011
December 9, 2013
November 2011
October 2013   (final data collection date for primary outcome measure)
BNP (a blood test which is a biomarker for heart failure) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01431157 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure
Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure

Sleep apnea syndrome is clinically defined by frequent pauses in breathing during sleep and symptoms, such as being tired. It can decrease the restfulness of sleep and decreases the level of oxygen in the blood. Sleep apnea patients suffer from daytime sleepiness, hypertension, coronary artery disease (CAD), stroke, ischemic heart disease, arrhythmias, pulmonary hypertension, heart failure, and premature death. There is significant evidence suggesting that nighttime decreases in blood oxygen levels are the primary cause of many of the abnormalities associated with this disease.

Epidemiological studies have demonstrated a surprisingly high prevalence of sleep apnea. Mild sleep apnea is present in 17% of adults in the general population and moderate to severe sleep apnea is present in 5.7% of adults. Among patients with heart failure the prevalence skyrockets. Multiple studies have found the prevalence of moderate to severe sleep apnea to be anywhere from 11-53% in heart failure patients.

Continuous positive airway pressure (CPAP) therapy is currently the standard of care for sleep apnea sufferers regardless of the severity of their disease. In patients without heart failure, CPAP therapy has numerous benefits and several long term studies have reported that CPAP causes less cardiovascular disease as well as a long term improvement in cardiovascular symptoms and mortality among patient with severe sleep apnea.

In heart failure patients, CPAP has shown some beneficial short term effects but evidence of long term improvements in symptoms and mortality are lacking. Compliance with CPAP therapy reduces systolic blood pressure, improves cardiac function, raises oxygen levels, and increases exercise tolerance. On the other hand, CPAP has not been shown to affect survival or number of hospitalizations in heart failure patients. Moreover, compliance with CPAP is often poor and many people cannot tolerate it. This further limits the therapeutic effectiveness of this intervention.

The purpose of this study is to assess whether nocturnal oxygen administration via nasal cannula alone can improve outcomes in congestive heart failure patients with moderate to severe sleep apnea. The effects of nocturnal oxygen administration will be assessed by using biomarkers of heart stress and markers of whole body inflammation.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Apnea
  • Heart Failure
  • Procedure: Nocturnal nasal oxygen
    Nasal oxygen at 2 l/min will be given at night
  • Other: No nasal oxygen
    Patients will have no intervention for sleep apnea
  • Active Comparator: Nasal oxygen
    Nocturnal nasal oxygen
    Intervention: Procedure: Nocturnal nasal oxygen
  • Placebo Comparator: No nasal oxygen
    Intervention: Other: No nasal oxygen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • RDI > 15
  • Symptomatic Heart failure
  • Oxygen saturation < 88% during apnea
  • Not currently be on nocturnal oxygen therapy, CPAP, or other PAP therapy

Exclusion Criteria:

  • Hypoxemia requiring oxygen supplementation
  • serum creatinine > 2.5 or on chronic dialysis
  • blood pressure > 160
  • pregnant
  • chronic physical disability that would prevent subjects from participating in any aspect of the trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01431157
HP-00049080
No
Steve Gottlieb, University of Maryland
University of Maryland
Not Provided
Not Provided
University of Maryland
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP