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 : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Central Sleep Apnea||Drug: Oxygen Other: Room Air||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||858 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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)|
|Actual Study Start Date :||April 15, 2019|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2023|
Active Comparator: Nocturnal Oxygen Therapy
Active nocturnal oxygen therapy
Active nocturnal oxygen concentrator
Sham Comparator: Sham Nocturnal Oxygen Therapy
Sham nocturnal oxygen therapy (room air)
Other: Room Air
Sham nocturnal oxygen concentrator (room air)
Other Name: Sham Oxygen
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745898
|Contact: Emily Kaplanfirstname.lastname@example.org|
|Contact: Michelle Reid, MPHemail@example.com|