Clinical Trial: High-Flow-Therapy for the Treatment of Cheyne-Stokes-Respiration in Chronic Heart Failure
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: High-Flow-Therapy for the Treatment of Cheyne-Stokes-Respiration in Chronic Heart Failure
Brief Summary: To demonstrate the effectiveness and safety of nocturnal ventilation with oxygen (HFT - high-flow-therapy) for the treatment of CSA in patients with HFrEF compared to placebo (patient will breathe ambient air via nasal cannula that is not connected to the high-flow-device).
Detailed Summary:
In chronic heart failure (CHF) patients sleep disordered breathing mainly comprises two different entities: obstructive sleep apnea (OSA) and central sleep apnea with Cheyne-Stokes respiration (CSA). Being a rare disease in the general population, CSA is found with a prevalence of up to 40% in CHF patients.1 This rise in prevalence is instigated by pathophysiological overlapses. CSA is precipitated by hyperventilation and a highly sensitive hypocapnea-induced apneic threshold, whereby apnea is then initiated by small transient reductions in partial pressure of carbon dioxide (pCO2). Underlying mechanisms are not fully understood, yet. Despite neurohumoral derangement such as altered chemoreflex cascades (enhanced "loop gain" and "controller gain") and circulatory delay, pulmonary congestion is thought to play a role in the evolution of CSA. Caused by reduced cardiac output and/or impaired left ventricular filling pattern, a rise in pulmonary capillary wedge pressure (PCWP) with resulting interstitial pulmonary edema is closely correlated to the occurrence of CSA. Furthermore, acute increase in pulmonary congestion by overnight rostral fluid displacement to the lungs was found to lower sleep pCO2 and predisposed to CSA. Furthermore, decreased blood oxygen tension stimulates the discharge of peripheral chemoreceptors and gives rise to hyperventilation pattern of CSA. Conversely, hyperventilation increases the propensity for central apneas by reducing the CO2-reserve. Underlining the importance of hypoxemic chemoreceptor stimulation in the development of CSA, previous studies exemplified this as a pathophysiological key element in patient with pulmonary artery hypertension, where hypocapnia, periodic breathing and CSA is highly prevalent despite normal capillary wedge pressure values. Also in heart failure patients this seems to be important: several interventional studies showed an at least partial supp
Sponsor: Heart and Diabetes Center North-Rhine Westfalia
Current Primary Outcome: Reduction of hypoxemic burden [ Time Frame: From date of enrolment until end of therapy phase (day 3). Hypoxemic burden is determined several times during this period. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Heart and Diabetes Center North-Rhine Westfalia
Dates:
Date Received: March 21, 2017
Date Started: February 2, 2017
Date Completion: September 2018
Last Updated: April 11, 2017
Last Verified: April 2017
