Completed

OPTIMAL-HFComparison of Oxygen and PAP Therapies for Sleep Apnea in Chronic Heart Failure

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Study Aim

This study aims to compare the effectiveness of Oxygen and PAP Therapies on improving Left Ventricular Ejection Fraction in individuals with Sleep Apnea who also have Chronic Heart Failure.

What is being tested

Continuous positive airway pressure

+ Healthy Lifestyle and Sleep Education

+ Nocturnal supplemental oxygen

DeviceBehavioral
Who is being recruted

Apnea+8

+ Cardiovascular Diseases

+ Heart Diseases

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: June 2014
See protocol details

Summary

Principal SponsorVA Office of Research and Development
Last updated: January 25, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: June 23, 2014

Actual date on which the first participant was enrolled.

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.

Principal SponsorVA Office of Research and Development
Last updated: January 25, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

74 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaCardiovascular DiseasesHeart DiseasesNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasHeart FailureSleep Apnea Syndromes

Criteria

7 inclusion criteria required to participate
Ability to provide informed consent

Age 18 years

LVEF < 45%

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

Show More Criteria

14 exclusion criteria prevent from participating
Awake resting oxyhemoglobin saturation < 89%

Current use of a positive airway pressure device (including continuous or bi-level positive airway pressure or adaptive servo-ventilation) or supplemental oxygen therapy

History of heart transplantation

Hospitalization for acute decompensated HF within previous 30 days

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Nocturnal continuous positive airway pressure

Group II

Experimental
Nocturnal supplemental oxygen

Group III

Healthy lifestyle and sleep education control

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

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

West Haven, United StatesOpen VA Connecticut Healthcare System West Haven Campus, West Haven, CT in Google Maps

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

Boston, United States
Completed2 Study Centers