Table 1.
Key characteristics of studies on treatment of sleep disordered breathing in adults with heart failure with preserved ejection fraction.
| 1st author, county, year | Sampl e size | Study Design | Sample | Mean age (years) | % Women, % HFpEF | PAP Device/ Comparison Group | Study Duration | Therapeutic Benefits |
|---|---|---|---|---|---|---|---|---|
| Bitter, Germany 2010 | N= 60 | Observational Prospective | Type of HF: HFpEF class II – III, LVEF ≥ 50% Type of SDB: Moderate to Severe, AHI > 15/h with CSR |
69 ± 8 | 15, 100% | ASV (n = 39)/Comparison (rejected treatment, stopped treatment, or noncompliant; n = 21) | 11.6 ± 3 months | Improved respiratory function (AHI longest apnea and hypopnea length, maximum and mean oxygen desaturation, percentage of study time with an oxygen saturation of < 90%), functional capacity (cardiopulmonary exercise testing), cardiac function (echocardiography measure), and NYHA functional class (ES = −0.67); all p- values < 0.05. |
| Oldenburg, Germany, 2013 | N= 45 | Observational Prospective | Type of HF: Both HFpEF and HFrEF, LVEF ≥ 50% Type of SDB: Moderate to Severe, AHI ≥ 15/h with Central and Mixed apneas |
71 ± 10 | 9, 56% | ASV (N=38)/No comparison | 3.6 ± 1.2 months | Improved NYHA functional class (ES = −0.80), exercise tolerance and oxygen uptake via cardiopulmonary exercise test, and AHI. |
| Yoshihisa, Japan, 2013 | N= 36 | Randomized control trial | Type of HF: HFpEF (LVEF > 50%) Type of SDB: Moderate to Severe, AHI > 15/h with OSA and CSR-CSA |
64 ± 14 | 19, 100% | ASV (n = 18)/Comparison (Usual care; n = 18) | 6 months, long term follow up | Improved cardiac diastolic function, arterial stiffness, NYHA Functional class (ES = −1.60), and decrease in cardiac death and hospitalizations due to cardiac disease, all p-values < 0.05. |
| Yoshihisa, Japan, 2015 | N= 109 | Observational Prospective | Type of HF: HFpEF (LVEF > 50%) Type of SDB: AHI ≥ 15/h with OSA, CSA, or Mixed |
68 ± 13 | 37, 100% | CPAP & ASV (n = 31)/Comparison (Usual care; n = 78) | 6 months, long term follow up | Improved, systolic and diastolic blood pressure, % vital capacity, peak oxygen uptake, NYHA Functional class (ES = −1.60), and a reduced cardiac and all-cause mortality, all p- values < 0.05. |
| Arikawa, Japan, 2016 | N = 58 | Observational Prospective | Type of HF: HFpEF (LVEF ≥ 50%) Type of SDB: Mild to severe, AHI ≥ 5, OSA |
65 ± 15 | 41%, 100% | CPAP (n=39)/ Comparison (non-OSA; n = 19) | 36 months | BNP levels were higher in those with OSA + CPAP vs comparison group at: 6 months [221 (137–324) vs 76 (38–96) pg/ml, p<0.05], 12 months [123 (98–197) vs 52 (38–76) pg/ml, p<0.05] and 36 months [115 (64–174) vs 56 (25–74) pg/ml, p<0.05] |
| O’Connor, Germany and United States 2017 | N = 126 | Randomized, control trial, prospective, multicenter | Type of HF: Both HFrEF (LVEF ≤ 45%) and HFpEF (LVEF > 45%) Type of SDB: Moderate to Severe, AHI ≥ 15, CSA, OSA, and mixed |
62 ± 14 | 32, 19% | ASV (n = 65)/Comparison (usual care; n = 61) | 6 months | Enrollment stopped early (126 of 215 planned) following the release of the SERVE-HF results, limiting statistical power. Improvements to AHI only. Subgroup analysis with HFpEF suggested significant positive effect on a composite global rank score (hierarchy of death, cardiovascular hospitalizations, and percent changes in 6-min walk distance) at 6 months (p = 0.036). |
Note: AHI = apnea/hypopnea index, ASV = adaptive servo-ventilation, BNP = Plasma Brain Natriuretic Peptide, CPAP = continuous positive airway pressure, CSA = central sleep apnea, CSR = Cheyne-Stokes Respirations, ES = Effect Size, HF = Heart Failure, HFpEF = heart failure with preserved ejection fraction, HFrEF = heart failure with reduced ejection fraction, LVEF = left ventricular ejection fraction, OSA = obstructive sleep apnea, PAP = positive airway pressure, SDB = sleep disordered breathing.