N/A
Completed N=21
Auto-PAP for Pulmonary Hypertension Treatment in Decompensated HF Patients With Sleep Apnea.
Sleep Apnea, Obstructive · Hypertension, Pulmonary · Heart Failure
Source: ClinicalTrials.gov NCT02963597 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Pulmonary Artery Systolic Pressure. — 58.6; 62.7; 42.8; 57.5 mmHg
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Artery Systolic Pressure. |
58.6; 62.7; 42.8; 57.5 | — |
| SECONDARY Functional Parameters (6 Minute Walk Test) From Baseline to 48hrs |
202.6; 153.6; 222.6; 161.8 | — |
| SECONDARY N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to 48hrs |
1087.6; 1532.7; 466.5; 1500.2 | — |
| SECONDARY Length of Stay |
9.2; 13.7 | — |
| SECONDARY Blood Oxygenation. |
72.84; 76.7; 80; 77.9 | — |
| SECONDARY Heart Failure Symptoms |
3.2; 3.5 | — |
| SECONDARY Fluid Retention |
82.6; 94.7 | — |
| SECONDARY E/e' as an Assumption of LVEDP. |
18.6; 18.2; 14.8; 16.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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%
Data sourced from ClinicalTrials.gov (NCT02963597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.