NCT03745898

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Heart Failure
• Central Sleep Apnea

Interventions

Type	Name	Description
DRUG	Oxygen	Active nocturnal oxygen concentrator
OTHER	Room Air	Sham nocturnal oxygen concentrator (room air)

Timeline

• Start date: 2019-04-15
• Primary completion: 2022-06-17
• Completion: 2022-06-17
• First posted: 2018-11-19
• Last updated: 2023-08-01
• Results posted: 2023-08-01

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study