Oxygen Versus PAP for Treatment of Sleep Apnea in Chronic Heart Failure (OPTIMAL-HF)
This study is not yet open for participant recruitment.
Verified March 2013 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: March 6, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | July 2013 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01807897
Contacts
| Contact: Daniel J Gottlieb, MD | (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 Medical Center, Jamaica Plain Campus | Not yet recruiting |
| Boston, Massachusetts, United States, 02130 | |
| Contact: Daniel J Gottlieb, MD 857-203-6375 daniel.gottlieb@va.gov | |
| Principal Investigator: Daniel J. Gottlieb, MD | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Daniel J. Gottlieb, MD | VA Medical Center, Jamaica Plain Campus |
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: | March 6, 2013 |
| 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:
|
Sleep Apnea Syndromes Apnea Heart Failure Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Heart Diseases Cardiovascular Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013