Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients

NCT01377987 | Completed Results

• 1 other identifier: 2011-P-000049/1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)

  The frequency of apneas and hypopneas (apnea-hypopnea index) was assessed. The primary measure was the value for non-REM supine sleep. A higher value indicates more severe sleep apnea. A value above 15 indicates the presence of moderate-to-severe sleep apnea.

  1 week

Secondary Outcomes (5)

• Ventilatory Chemoreflex Sensitivity, "Loop Gain" Using Carbon Dioxide Pulses

  1 week

• Sympathetic Activity (Urinary Norepinephrine)

  1 week

• Left-atrial Volume

  1 week

• Brain Natriuretic Peptide (NT-proBNP)

  1 week

• Pittsburgh Sleep Quality Index

  1 week

Study Arms (2)

Acetazolamide

EXPERIMENTAL

Drug: Acetazolamide

Sugar pill

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Acetazolamide DRUG

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

Also known as: Diamox

Acetazolamide

Placebo DRUG

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

Sugar pill

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left ventricular ejection fraction (EF) \<50%, or heart failure with preserved EF
• Age 18-89

You may not qualify if:

• 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

Sponsors & Collaborators

• David Andrew Wellman: lead
• American Heart Association: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Scott Sands
• Organization: Brigham and Women's Hospital

sasands@bwh.harvard.edu

617 278 0911

Study Officials

• Andrew Wellman, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Atul Malhotra, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 22, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 13, 2018
• Results First Posted: June 13, 2018

Record last verified: 2018-05

Locations

US (1)