N/A
Completed N=29
Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients
Heart Failures
Source: ClinicalTrials.gov NCT01377987 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI) — 26.3; 36.1; 32.3; 44.6 events per hour
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.
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 | — |
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. Informational only — not medical advice.