Oxygen Versus PAP for Treatment of Sleep Apnea in Chronic Heart Failure (OPTIMAL-HF)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01807897
First received: March 1, 2013
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to compare three treatment modalities for central, or mixed obstructive and central, sleep apnea in patients with chronic heart failure and reduced ejection fraction. The modalities to be tested are nocturnal supplemental oxygen (NSO), continuous positive airway pressure (CPAP), and adaptive servo-ventilation (ASV). The main outcome measures will be left ventricular ejection fraction on echocardiogram and peak oxygen consumption on cardiopulmonary exercise testing.


Condition Intervention Phase
Heart Failure
Sleep Apnea Syndromes
Device: Continuous positive airway pressure
Device: Adaptive pressure-support servo-ventilation
Device: Nocturnal supplemental oxygen
Behavioral: Healthy Lifestyle and Sleep Education
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxygen Versus PAP for Treatment of Sleep Apnea in Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Left ventricular ejection fraction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Standard transthoracic 2-dimensional and Doppler echocardiography will be performed. M-mode measurements of LV dimensions will be performed and analyzed according to the American Society of Echocardiography recommendations and LVEF measured using the modified Simpson's method.


Secondary Outcome Measures:
  • Peak oxygen consumption (VO2 peak) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Treadmill exercise testing will be performed using a motor-driven treadmill and a modified Naughton protocol, with a lightweight disposable pneumotach device positioned in the participant's mouth interfaced with a metabolic cart. VO2 peak will be the co-primary outcome of the study. Secondary outcome measures from cardiopulmonary exercise testing include VO2 at anaerobic threshold and VE/VCO2 slope.

  • 24-hour Ambulatory Blood Pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    24-hour blood pressure will be measured using a blood pressure cuff that is connected by rubber tubing to a small pressure monitoring device, programmed to measure BP at 20 minute intervals during the day and 30 minute intervals at night (11 PM to 7 AM) for a period of 24 hours. We will assess 24-hour mean arterial pressure as the primary blood pressure outcome, with additional assessment of nocturnal versus diurnal blood pressure effects.

  • Amino-terminal propeptide of type III collagen [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    A markers of cardiac remodeling

  • B-type natriuretic peptide [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • hs-CRP [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 161
Study Start Date: April 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CPAP
Nocturnal continuous positive airway pressure
Device: Continuous positive airway pressure
Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index
Other Name: CPAP
Behavioral: Healthy Lifestyle and Sleep Education
A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
Other Name: HLSE
Experimental: ASV
Nocturnal adaptive pressure-support servo-ventilation
Device: Adaptive pressure-support servo-ventilation
Nocturnal adaptive pressure-support servo-ventilation, titrated to minimize apnea-hypopnea index
Other Name: ASV
Behavioral: Healthy Lifestyle and Sleep Education
A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
Other Name: HLSE
Experimental: NSO
Nocturnal supplemental oxygen
Device: Nocturnal supplemental oxygen
Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia
Other Name: NSO
Behavioral: Healthy Lifestyle and Sleep Education
A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
Other Name: HLSE
HLSE
Healthy lifestyle and sleep education control
Behavioral: Healthy Lifestyle and Sleep Education
A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
Other Name: HLSE

Detailed Description:

Chronic heart failure (HF) is a highly prevalent disease, with a lifetime risk of approximately 20%. Sleep apnea is a common co-morbid condition, occurring in approximately half of patients with chronic HF, and often has predominantly central or mixed obstructive and central characteristics. Although it is associated with increased mortality in patients with HF, sleep apnea is usually asymptomatic and patients are therefore often unwilling to accept standard therapy with positive airway pressure. There are three treatment modalities currently recommended by the American Academy of Sleep Medicine for the treatment of predominantly central sleep apnea in HF patients: nocturnal supplemental oxygen (NSO), continuous positive airway pressure (CPAP) and adaptive servo-ventilation (ASV). There are only limited data on the comparative efficacy and tolerability of these three modalities. The present study is designed to compare these modalities with respect to effects on ventricular function, exercise capacity, and other measures of cardiovascular risk.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veteran receiving care within the Veterans Health Administration healthcare system
  • Age 18 years
  • Physician diagnosis of chronic heart failure, American Heart Association Stage C-D
  • LVEF <45%
  • No change in active cardiac medications for 4 weeks prior to randomization
  • Ability to provide informed consent
  • Moderate to severe central or mixed central and obstructive sleep apnea, defined as an apnea-hypopnea index (AHI) 15 events per hour, with a central AHI >5 events/hour

Exclusion Criteria:

  • Hospitalization for acute decompensated HF within previous 90 days
  • Hospitalization for myocardial infarction or cardiac surgery within previous 90 days
  • Presence of a left ventricular assist device
  • History of heart transplantation
  • Poorly controlled hypertension (>170/>110)
  • Poorly controlled diabetes (HbA1c > 9.0)
  • Severe renal failure with estimated glomerular filtration rate <30 ml/min
  • Prior stroke with functional impairment or other severe, uncontrolled medical problems that may impair ability to participate in the study exams, based on medical history and review of medical records
  • Severe chronic insomnia, with reported usual sleep duration <4 hours
  • Severe daytime sleepiness, defined as Epworth Sleepiness Scale score 18 or higher or a report of falling asleep driving during the previous year
  • Awake resting oxyhemoglobin saturation <89%
  • Pregnancy
  • Smoking by subject or other person in the subject's bedroom, or other open flame in bedroom
  • Current use of a positive airway pressure device (including continuous or bi-level positive airway pressure or adaptive servo-ventilation) or supplemental oxygen therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807897

Contacts
Contact: Daniel J Gottlieb, MD MPH (857) 203-6375 daniel.gottlieb@va.gov

Locations
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Not yet recruiting
West Haven, Connecticut, United States, 06516
Contact: Henry K Yaggi       klar.yaggi@va.gov   
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Not yet recruiting
Boston, Massachusetts, United States, 02130
Contact: Daniel J Gottlieb, MD MPH    857-203-6375    daniel.gottlieb@va.gov   
Principal Investigator: Daniel J. Gottlieb, MD MPH         
Sponsors and Collaborators
Investigators
Principal Investigator: Daniel J. Gottlieb, MD MPH VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01807897     History of Changes
Other Study ID Numbers: CLIN-008-12S
Study First Received: March 1, 2013
Last Updated: April 17, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Heart Failure
Sleep Apnea
Ventricular Ejection Fraction
Exercise Test

Additional relevant MeSH terms:
Apnea
Heart Failure
Sleep Apnea Syndromes
Cardiovascular Diseases
Dyssomnias
Heart Diseases
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 23, 2014