Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients

NCT ID: NCT01377987

Last Updated: 2018-06-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Acetazolamide

Group Type EXPERIMENTAL

Acetazolamide

Intervention Type DRUG

4 mg/kg, once daily before bed, for 7 days

Sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

4 mg/kg, once daily before bed, for 7 days

Interventions

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Acetazolamide

4 mg/kg, once daily before bed, for 7 days

Intervention Type DRUG

Placebo

4 mg/kg, once daily before bed, for 7 days

Intervention Type DRUG

Other Intervention Names

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Diamox

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

David Andrew Wellman

OTHER

Sponsor Role lead

Responsible Party

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David Andrew Wellman

Associate Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrew Wellman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Atul Malhotra, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2011-P-000049/1

Identifier Type: -

Identifier Source: org_study_id

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