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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00746954 |
The purpose of this study is to determine whether buspirone compared to acetazolamide and to placebo will reduce the number and/or severity of breathing pauses during sleep that occur in some patients with Heart Failure.
Condition | Intervention | Phase |
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Central Apnea Heart Failure |
Drug: Acetazolamide Drug: Buspirone |
Phase III |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study |
Official Title: | Buspirone as a Potential Treatment for Recurrent Central Apneas |
Estimated Enrollment: | 20 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
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Drug: Acetazolamide
Cabonic Anhydrase inhibitor
Drug: Buspirone
Agonist of a 5-HT1a receptor with some D2 agonist properties.
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The hypothesis is that buspirone is a safe, effective drug to reduce the occurrence of recurrent central apnea and irregular breathing found in the setting of heart failure. A secondary hypothesis is that its effect will be similar to that or acetazolamide. Study Design: A one-dose double-blind crossover study of buspirone vs. placebo vs. acetazolamide will be performed to determine if active drug alters the number and/or severity of recurrent central apneas and hypopneas (AHI) in patients with heart failure. AHI is the primary outcome variable. In the initial phase of this study, we will recruit 18-20 patients to obtain ~15 complete studies, using the assumption of a ~20% drop-out, to reach a pre-set significance level of a 30% reduction in AHI in the drug groups with a power of 0.90 and a p=0.05 by post-hoc testing. Power estimates were calculated using the means and SDs derived from the population reported the study of acetazolamide by Javaheri et al (2006). A 30% reduction in AHI would be meaningful. A 15% dropout rate was present in the study by Javaheri et al (2006), but as our study is a three-way comparison, we chose a slightly higher rate. The reasons stated in these articles for a drop out included: viral illness, GI upset (on placebo or on theophyllin), tired of the sleep studies, and desire to terminate without cause. Statistical Analyses. Analysis of variance for repeated measures using Sidak's correction will be used to compare placebo, buspirone, and acetazolamide studies. For variables that are not normally distributed, Dunn's nonparametric test for multiple comparisons will be used. p > 0.05 will be considered significant. Mean values and SDs will be reported.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use the following medications:
Contact: Scott Smith, RRT | (216) 791-3800 ext 6025 | Scott.Smith@va.gov |
United States, Ohio | |
VA Medical Center, Cleveland | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Scott Smith, RRT 216-791-3800 ext 6025 Scott.Smith@va.gov | |
Principal Investigator: Kingman P. Strohl, MD |
Principal Investigator: | Kingman P. Strohl, MD | VA Medical Center, Cleveland |
Responsible Party: | Department of Veterans Affairs ( Strohl, Kingman - Principal Investigator ) |
Study ID Numbers: | RESP-006-07F |
Study First Received: | September 2, 2008 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00746954 |
Health Authority: | United States: Federal Government |
buspirone acetazolamide |
Heart Failure Sleep Apnea Syndromes Heart Diseases Apnea Respiration Disorders Acetazolamide Sleep Disorders Dyssomnias |
Serotonin Recurrence Sleep Disorders, Intrinsic Buspirone Signs and Symptoms Respiratory Tract Diseases Sleep Apnea, Central Signs and Symptoms, Respiratory |
Serotonin Agonists Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Diuretics Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Cardiovascular Agents Pharmacologic Actions Carbonic Anhydrase Inhibitors Serotonin Agents Natriuretic Agents Therapeutic Uses Anti-Anxiety Agents Cardiovascular Diseases Central Nervous System Agents Anticonvulsants |