Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients
Information source: Brigham and Women's Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: Acetazolamide (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Atul Malhotra, MD Official(s) and/or principal investigator(s):
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 least severe ventilatory control instability (lowest 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 dioxideSympathetic activity (urinary norepinephrine) Cardiac function, assessed by echocardiography Closing volume Brain natriuretic peptide (BNP and NT-proBNP) Subjective sleep quality, breathlessness, fatigue (Quality of life) Troponin I
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- LVEF<50%
- Age 18-80
Exclusion Criteria:
- severe obstructive respiratory disease
- unstable heart failure status
- recent use of positive airway pressure therapy
- current use of medications known to affect ventilation
- severe kidney disease
- hemoglobin <9. 5g/dl (moderate-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: October 19, 2012
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