Clinical trial NCT03745898: The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea
Official title: The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea (LOFT-HF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Failure
Central Sleep Apnea
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2018-11-19
Enrollment: 98
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: First Occurrence of Mortality Due to Any Cause or an Unplanned Hospitalization for Worsening Heart Failure or a Life-saving Cardiovascular (CV) Intervention
timeFrame: 12 months
Secondary outcomes:
measure: Recurrent Event Analyses of Mortality and Morbidity
timeFrame: From enrollment to study termination, attrition or death. Min = 41 days, Max = 626 Days
measure: Quality of Life and Symptoms - HF Disease-specific Quality of Life
timeFrame: Baseline, 6 month follow up
measure: Quality of Life and Symptoms - Generic-quality of Life
timeFrame: Baseline, 6 month follow up
measure: Quality of Life and Symptoms - Depressive Symptoms
timeFrame: Baseline, 6 month follow up
measure: Quality of Life and Symptoms - Sleep Symptoms and Sleep Related Daytime Impairment
timeFrame: Baseline, 6 month follow up
measure: Functional Status
timeFrame: Baseline, 6 month follow up
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Stanford
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Kansas City
country: United States
facility: Saint Luke's Mid America Health Institute
state: Kansas
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico School of Medicine
state: New Mexico
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Highland Hills
country: United States
facility: University Hospitals
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
References: