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The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03745898
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : February 11, 2021
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Susan Redline, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE November 9, 2018
First Posted Date  ICMJE November 19, 2018
Last Update Posted Date February 11, 2021
Actual Study Start Date  ICMJE April 15, 2019
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
First occurrence of mortality due to any cause or an unplanned hospitalization for worsening heart failure or a life-saving cardiovascular (CV) intervention [ Time Frame: Through study completion, an average of 2.5 years ]
This is a composite primary outcome
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
First occurrence of mortality due to any cause or an unplanned hospitalization for worsening heart failure or a life-saving CV intervention [ Time Frame: Through study completion, an average of 2.5 years ]
This is a composite primary outcome
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
  • Recurrent event analyses of morbidity [ Time Frame: Through study completion, an average of 2.5 years ]
  • Recurrent event analyses of mortality [ Time Frame: Through study completion, an average of 2.5 years ]
  • Exercise capacity [ Time Frame: 12 months ]
    Exercise capacity will be assessed by the change in 6-minute hall walk distance (6MHWD) test
  • Quality of Life and Symptoms - HF disease-specific quality of life [ Time Frame: 12 months ]
    HF disease-specific quality of life will be assessed by the change in the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for those who have heart failure. An overall summary score is derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
  • Quality of Life and Symptoms - Generic-quality of life [ Time Frame: 12 months ]
    Generic-quality of life will be assessed by the change in the Euroqol - 5 Dimensions (EQ-5D) questionnaire. The questionnaire comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. There is no total score or range.
  • Quality of Life and Symptoms - Depressive symptoms [ Time Frame: 12 months ]
    Depressive symptoms will be assessed by the change in the Patient Health Questionnaire - 8 items (PHQ-8). A scores ranges from 0 to 24. A score greater than 10 is considered major depression and a score 20 or more is considered severe major depression.
  • Quality of Life and Symptoms - Sleep symptoms and sleep related daytime impairment [ Time Frame: 12 months ]
    Sleep symptoms and sleep related daytime impairment will be assessed by the change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance and Sleep Related Impairment Questionnaires. Scores range from 8 - 40. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10.
  • Functional Status [ Time Frame: 12 months ]
    Functional status will be assessed by the change in New York Heart Association (NYHA) Functional Class Ranking
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
  • Recurrent event analyses of morbidity [ Time Frame: Through study completion, an average of 2.5 years ]
  • Recurrent event analyses of mortality [ Time Frame: Through study completion, an average of 2.5 years ]
  • Exercise capacity [ Time Frame: 12 months ]
    Exercise capacity will be assessed by the change in 6-minute hall walk distance (6MHWD) test
  • Quality of Life and Symptoms - HF disease-specific quality of life [ Time Frame: 12 months ]
    HF disease-specific quality of life will be assessed by the change in the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for those who have heart failure. An overall summary score is derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
  • Quality of Life and Symptoms - Generic-quality of life [ Time Frame: 12 months ]
    Generic-quality of life will be assessed by the change in the EQ-5D questionnaire. The questionnaire comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. There is no total score or range.
  • Quality of Life and Symptoms - Depressive symptoms [ Time Frame: 12 months ]
    Depressive symptoms will be assessed by the change in the Patient Health Questionnaire - 8 items (PHQ-8). A scores ranges from 0 to 24. A score greater than 10 is considered major depression and a score 20 or more is considered severe major depression.
  • Quality of Life and Symptoms - Sleep symptoms and sleep related daytime impairment [ Time Frame: 12 months ]
    Sleep symptoms and sleep related daytime impairment will be assessed by the change in the PROMIS Sleep Disturbance and Sleep Related Impairment Questionnaires. Scores range from 8 - 40. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10.
  • Functional Status [ Time Frame: 12 months ]
    Functional status will be assessed by the change in New York Heart Association (NYHA) Functional Class Ranking
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea
Official Title  ICMJE The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea (LOFT-HF)
Brief Summary The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Central Sleep Apnea
Intervention  ICMJE
  • Drug: Oxygen
    Active nocturnal oxygen concentrator
  • Other: Room Air
    Sham nocturnal oxygen concentrator (room air)
    Other Name: Sham Oxygen
Study Arms  ICMJE
  • Active Comparator: Nocturnal Oxygen Therapy
    Active nocturnal oxygen therapy
    Intervention: Drug: Oxygen
  • Sham Comparator: Sham Nocturnal Oxygen Therapy
    Sham nocturnal oxygen therapy (room air)
    Intervention: Other: Room Air
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 16, 2018)
858
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged ≥ 21 years at the date of consent.
  • History of chronic, stable heart failure with reduced ejection fraction with left ventricular ejection fraction (LVEF) ≤ 50% determined by echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, within the year prior to enrollment.
  • Central sleep apnea, defined using as an apnea-hypopnea index (AHI) > 15/h with ≥ 50% central events (apnea and hypopneas).
  • New York Heart Association (NYHA) Class III or IV, or NYHA Class II with any of the following:

    1. at least one hospitalization for heart failure within the 24 months prior to enrollment or;
    2. a BMI corrected BNP ≥ 300 pg/ml or a corrected NT-proBNP ≥ 1500 pg/ml or;
    3. an ED visit for HF exacerbation where the patient has received an IV diuretic within 12 months of enrollment.
  • Treatment with stable, optimized guideline-directed medical therapies (GDMT) according to applicable guidelines in the U.S. and Canada, where stable is defined as the addition of no new class of disease-modifying drug for ≥ 30 days prior to randomization (reasons for intolerance to GDNT must be documented).
  • In the investigator's opinion, willing and able to comply with all study requirements.
  • Able to fully understand study information and sign an Institutional Review Board (IRB) approved informed consent (including HIPAA authorization in the U.S.).

Exclusion Criteria:

  • Current positive airway pressure use or predominantly obstructive rather than central sleep apnea.
  • Oxygen saturation < 90% at rest during the day.
  • Nocturnal oxygen saturation < 88% for > 5 continuous minutes unaccompanied by apneas or hypopneas.
  • Chronic daytime or nighttime use of supplemental oxygen.
  • Participants and their bed-partners who currently smoke in the bedroom.
  • Severe pulmonary disease requiring continuous home oxygen therapy or the continuous or frequent intermittent use of oral steroids or documented severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) < 50%.
  • Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within the previous 3 months.
  • Transient ischemic attack or stroke within the previous 3 months.
  • Cardiac resynchronization therapy implantation scheduled or performed within 3 months prior to randomization.
  • Primary hemodynamically-significant uncorrected valvular heart disease (obstructive or regurgitant) or any valvular disease expected to require surgery during the trial.
  • Acute myocarditis/pericarditis or other cause of potentially reversible cardiomyopathy (e.g., post-partum cardiomyopathy, tachycardia-induced cardiomyopathy), within the previous 6 months.
  • End-stage (Stage D) heart failure (HF) requiring continuous outpatient intravenous (IV) inotropic therapy, placement of ventricular assist device, listing for cardiac transplantation, or end-of-life care (e.g. hospice care).
  • Pregnancy or of child bearing potential without a negative pregnancy test within 10 days prior to enrollment.
  • Life expectancy < 1 year for diseases unrelated to chronic HF.
  • Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound subject results in this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emily Kaplan 617-278-0382 ekaplan1@bwh.harvard.edu
Contact: Michelle Reid, MPH mlreid@bwh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03745898
Other Study ID Numbers  ICMJE U24HL140412-01_UG3
U24HL140412-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All relevant deidentified data will be deposited in Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) and the National Sleep Research Resource (NSRR)
Responsible Party Susan Redline, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Ohio State University
Investigators  ICMJE Not Provided
PRS Account Brigham and Women's Hospital
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP