Physiological Study to Predict Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients
Overview
- Phase
- Not Applicable
- Intervention
- Acetazolamide
- Conditions
- Heart Failures
- Sponsor
- David Andrew Wellman
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The ultimate goal is to improve our understanding of the pathophysiology and resistance to effective treatment of sleep disordered breathing in patients with heart failure, with a focus on selecting patients that will benefit specifically from acetazolamide treatment.
The study addresses three primary hypotheses: 1) Acetazolamide treatment will reduce the apnea-hypopnea index and improve markers of heart-failure severity in heart-failure patients with sleep apnea. 2) Acetazolamide will provide the greatest improvement in patients with the most severe ventilatory control instability (strongest chemoreflex response to carbon dioxide; highest loop gain). 3) Acetazolamide will act primarily via stabilizing ventilatory control (reducing loop gain), rather than via improvement to upper airway anatomy, pulmonary congestion, and cardiac function.
Investigators
David Andrew Wellman
Associate Professor of Medicine
Brigham and Women's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •severe obstructive respiratory disease
- •unstable heart failure status
- •recent use of positive airway pressure therapy
- •current use of opioids, benzodiazepines
- •severe kidney disease
- •severe anemia
Arms & Interventions
Acetazolamide
Intervention: Acetazolamide
Sugar pill
Intervention: Placebo
Outcomes
Primary Outcomes
The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)
Time Frame: 1 week
The frequency of apneas and hypopneas (apnea-hypopnea index) was assessed. The primary measure was the value for non-REM supine sleep. A higher value indicates more severe sleep apnea. A value above 15 indicates the presence of moderate-to-severe sleep apnea.
Secondary Outcomes
- Ventilatory Chemoreflex Sensitivity, "Loop Gain" Using Carbon Dioxide Pulses(1 week)
- Sympathetic Activity (Urinary Norepinephrine)(1 week)
- Left-atrial Volume(1 week)
- Brain Natriuretic Peptide (NT-proBNP)(1 week)
- Pittsburgh Sleep Quality Index(1 week)