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Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients

NCT01377987 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-06-13

Study results available
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Summary

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.

Conditions

  • Heart Failures

Interventions

DRUG

Acetazolamide

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

DRUG

Placebo

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

Sponsors & Collaborators

  • American Heart Association

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • David Andrew Wellman

    lead OTHER

Principal Investigators

  • Andrew Wellman, MD, PhD · Brigham and Women's Hospital

  • Atul Malhotra, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01377987 on ClinicalTrials.gov