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

Primary Purpose

Heart Failure, Sleep Apnea Syndromes

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Continuous positive airway pressure

Nocturnal supplemental oxygen

Healthy Lifestyle and Sleep Education

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Sleep Apnea, Ventricular Ejection Fraction, Exercise Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Connecticut Healthcare System West Haven Campus, West Haven, CT
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

CPAP

NSO

HLSE

Arm Description

Nocturnal continuous positive airway pressure

Nocturnal supplemental oxygen

Healthy lifestyle and sleep education control

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01807897

First Posted

March 1, 2013

Last Updated

December 29, 2022

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT01807897

Brief Title

Oxygen Versus PAP for Sleep Apnea in Heart Failure

Acronym

OPTIMAL-HF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

June 23, 2014 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Sleep Apnea Syndromes

Keywords

Heart Failure, Sleep Apnea, Ventricular Ejection Fraction, Exercise Test

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Continuous positive airway pressure (CPAP) and supplemental oxygen

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CPAP

Arm Type

Experimental

Arm Description

Nocturnal continuous positive airway pressure

Arm Title

NSO

Arm Type

Experimental

Arm Description

Nocturnal supplemental oxygen

Arm Title

HLSE

Arm Type

Other

Arm Description

Healthy lifestyle and sleep education control

Intervention Type

Device

Intervention Name(s)

Continuous positive airway pressure

Other Intervention Name(s)

CPAP

Intervention Description

Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index

Intervention Type

Device

Intervention Name(s)

Nocturnal supplemental oxygen

Other Intervention Name(s)

NSO

Intervention Description

Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia

Intervention Type

Behavioral

Intervention Name(s)

Healthy Lifestyle and Sleep Education

Other Intervention Name(s)

HLSE

Intervention Description

A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle

Primary Outcome Measure Information:

Title

Left Ventricular Ejection Fraction

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Peak Oxygen Consumption (VO2 Peak)

Description

Time Frame

3 months

Title

24-hour Ambulatory Blood Pressure

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel J Gottlieb, MD MPH

Organizational Affiliation

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

Facility Name

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02130

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Oxygen Versus PAP for Sleep Apnea in Heart Failure

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