N/A
N=29
Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients
Heart Failures
Bottom Line
View on ClinicalTrials.gov: NCT01377987 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI) — 26.3; 36.1; 32.3; 44.6 events per hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acetazolamide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- David Andrew Wellman
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI) |
26.3; 36.1; 32.3; 44.6 | — |
| SECONDARY Ventilatory Chemoreflex Sensitivity, "Loop Gain" Using Carbon Dioxide Pulses |
0.40; 0.49 | — |
| SECONDARY Sympathetic Activity (Urinary Norepinephrine) |
40.8; 35.0 | — |
| SECONDARY Left-atrial Volume |
34.3; 40.0 | — |
| SECONDARY Brain Natriuretic Peptide (NT-proBNP) |
919; 932 | — |
| SECONDARY Pittsburgh Sleep Quality Index |
6.7; 7.5 | — |
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.
Eligibility Criteria
Inclusion Criteria (Heart failure patients)
- Left ventricular ejection fraction (EF) <50%, or heart failure with preserved EF
- Age 18-89
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
Data sourced from ClinicalTrials.gov (NCT01377987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.