Oxygen Versus PAP for Sleep Apnea in Heart Failure

Heart Failure Clinical Trial

— OPTIMAL-HF  

Official title:

Oxygen Versus PAP for Treatment of Sleep Apnea in Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807897
• Other study ID #: CLIN-008-12S
• Status: Completed
• Phase: Phase 4
• Start date: June 23, 2014
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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) and continuous positive airway pressure (CPAP). The main outcome measures will be left ventricular ejection fraction on echocardiogram and peak oxygen consumption on cardiopulmonary exercise testing.

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. At the outset of this study, there were 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). Recently, ASV was found to increase mortality in patients with heart failure with reduced ejection fraction and central sleep apnea. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 30 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, and deemed a safety risk by study physician

• 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

Related Conditions & MeSH terms

• Apnea
• Heart Failure
• Sleep Apnea Syndromes

Intervention

Device:
• Continuous positive airway pressure
Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index
• Nocturnal supplemental oxygen
Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia

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

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Ejection Fraction	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. Measurement is change from baseline in LVEF.	3 months
Secondary	Peak Oxygen Consumption (VO2 Peak)	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. Change in VO2 peak between baseline and final visit 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.	3 months
Secondary	24-hour Ambulatory Blood Pressure	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. The investigators will assess 24-hour mean arterial pressure as the primary blood pressure outcome, with additional assessment of nocturnal versus diurnal blood pressure effects.	3 months