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Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure;; Controls Without Heart Failure

Intervention: Acetazolamide (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: David Andrew Wellman

Official(s) and/or principal investigator(s):
Andrew Wellman, MD, PhD, Principal Investigator, Affiliation: Brigham and Women's Hospital
Atul Malhotra, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital

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.

Clinical Details

Official title: Physiological Study to Predict Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: The severity of sleep disordered breathing (apnea-hypopnea index, AHI)

Secondary outcome:

Ventilatory stability, i.e. loop gain, ventilatory sensitivity to carbon dioxide

Sympathetic activity (urinary norepinephrine)

Cardiac function, assessed by echocardiography

Closing volume

Brain natriuretic peptide (NT-proBNP)

Subjective sleep quality, breathlessness, fatigue (Quality of life)

Troponin I

Eligibility

Minimum age: 18 Years. Maximum age: 89 Years. Gender(s): Both.

Criteria:

Inclusion Criteria (Heart failure patients)

- Left ventricular ejection fraction (EF) <50%, or heart failure with preserved EF

- Age 18-89

Inclusion Criteria (Controls)

- No history or evidence of heart failure

- 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

Locations and Contacts

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Scott A Sands, PhD, Email: sasands@partners.org
Additional Information

Starting date: August 2011
Last updated: January 7, 2014

Page last updated: November 27, 2014

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