Buspirone as a Potential Treatment for Recurrent Central Apnea

NCT00746954 | Terminated Phase 3 Results DMC

• 1 other identifier: RESP-006-07F
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 with Heart Failure.

Conditions

Central Apnea; Heart Failure

Keywords

buspirone; acetazolamide

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea Index (Number of Central and Mixed Apneas/Hour of Sleep)

  Overnight polysomnogram over 3 separate nights

Study Arms (3)

Arm 1 BUS to PLA to ACET

OTHER

Each patient will act as their own control, with comparisons over three nights, each night given buspirone (BUS 20mg), actetazolamide (ACET 250mg), or placebo (PLA) n=3

Drug: Acetazolamide; Drug: Buspirone

ARM 2 ACET to BUS to PLA

OTHER

Each patient will act as their own control, with comparisons over three nights, each night given buspirone (BUS 20mg), actetazolamide (ACET 250mg), or placebo (PLA) n=3

Drug: Acetazolamide; Drug: Buspirone

ARM 3 PLA to ACET to BUS

OTHER

Each patient will act as their own control, with comparisons over three nights, each night given buspirone (BUS 20mg), actetazolamide (ACET 250mg), or placebo (PLA) n=2

Drug: Acetazolamide; Drug: Buspirone

Interventions

Acetazolamide DRUG

Cabonic Anhydrase inhibitor

ARM 2 ACET to BUS to PLA; ARM 3 PLA to ACET to BUS; Arm 1 BUS to PLA to ACET

Buspirone DRUG

Agonist of a 5-HT1a receptor with some D2 agonist properties.

ARM 2 ACET to BUS to PLA; ARM 3 PLA to ACET to BUS; Arm 1 BUS to PLA to ACET

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Central; Heart Failure

Interventions

Acetazolamide; Buspirone

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Pyrimidines; Polycyclic Compounds

Limitations and Caveats

VA population turned out to have a high number of heart failure patients who had psychiatric co-morbidity or were empirically treated with antidepressants, precluding participation. There were not enrolled enough participants.

Results Point of Contact

• Title: Kingman P. Strohl MD
• Organization: Louis Stokes DVA Medical Center

kingman.strohl@va.gov

216-7913800

Study Officials

• Kingman P. Strohl, MD

  VA Medical Center-Cleveland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 4, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Locations

US (1)