Auto-PAP for Pulmonary Hypertension Treatment in Decompensated HF Patients With Sleep Apnea.
Completed · Not applicable
Conditions studied: Sleep Apnea, Obstructive, Hypertension, Pulmonary, Heart Failure
In brief
The objective of the study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.
Key facts
- Study ID
- NCT02963597
- Run by
- Albert Einstein Healthcare Network
- People needed
- 21
- Starts
- 2016-10-01
- Expected to finish
- 2018-08-15
- Last updated by the study team
- 2020-03-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or more
- Decompensated Congestive Heart Failure with systolic Pulmonary Artery pressures of ≥50 mmHg (including Right Atrial pressure)
- Prior clinical diagnosis of heart failure
- Moderate to Severe predominately obstructive sleep disordered breathing documented by polygraphy with Apnea Hypopnea Index (AHI) ≥20e/h and 5% of the time spent <90% O2 Sat (minimum 2hr recording time)
- Patient is able to fully understand study information and sign informed consent
You may not qualify if…
- Chronic renal insufficiency (Hemodialysis or serum creatinine > 2)
- Hemodynamically significant valvular disease
- Severe arthritis or inability to complete 6 Minute Walk Test
- Left Ventricular Assist Device/ heart transplant or hemodynamically unstable
- Patient taking any Pulmonary vasodilators, including home oxygen.
- Known diagnosis of Obstructive Sleep Apnea (OSA) and on active therapy
- 80% of the respiratory events being central/Cheyne-Stokes breathing
- Recent cardiac surgery (within 30 days of admission)
- Recent stroke (within 30 days of admission or with persistent neurological deficits)
- Severe Chronic Obstructive Pulmonary Disease defined as forced expiratory volume at one second (FEV1) < 50%
Where it is running
- Albert Einstein Healthcare Network — Philadelphia, Pennsylvania, United States
- Heart and Diabetes Center NRW — Bad Oeynhausen, North Rhine-Westphalia, Germany
Full record on ClinicalTrials.gov
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