Status:
TERMINATED
Buspirone as a Potential Treatment for Recurrent Central Apnea
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University Hospitals Cleveland Medical Center
Conditions:
Central Apnea
Heart Failure
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Ability to provide informed consent,
- Ambulatory and in stable condition for the past 4 months,
- A diagnosis of heart failure with left ventricular systolic dysfunction as evidenced by an ejection fraction \<35%,
- NYHA class II or III clinical status, and
- Diagnosis of dilated cardiomyopathy or ischemic cardiomyopathy.
Exclusion
- Unstable angina, unstable heart failure, acute pulmonary edema, congenital heart disease
- History of unstable and/or advanced hepatic disease
- History of renal failure, CrCL \< 30
- Current use of an SSRI, or use within one month of testing
- Intrinsic pulmonary diseases: ILD and/or COPD (FEV1/FVC \< 65%)
- Kyphoscoliosis or neuromuscular disease
- Suboptimally treated hypothyroidism
- Use of narcotics or benzodiazepines
- Use of theophylline or pseudoephedrine
- Use the following medications:
- MAO inhibitors
- diazepam
- haloperidol
- nefazodone
- trazodone
- erythromycin
- grapefruit juice
- itraconazole
- rifampin
- ketoconazole
- ritonavir,
- cimetidine
- Known allergy to buspirone or acetazolamide
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00746954
Start Date
September 1 2008
End Date
December 1 2011
Last Update
March 14 2016
Active Locations (1)
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1
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106