Buspirone as a Potential Treatment for Recurrent Central Apnea

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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 with Heart Failure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: University Hospitals Cleveland Medical Center
• Treatments: Acetazolamide; Buspirone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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