Pathophysiologie der Cheyne-Stokes Atmung: senkung des pulmonalkapillären Wedge-Drucks als kausaler Therapieansatz

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2010
INTERVENTION: Trade Name: Perlinganit Pharmaceutical Form: Intravenous infusion INN or Proposed INN: GLYCERYL TRINITRATE CAS Number: 55630 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use Trade Name: Ventavis Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: ILOPROST CAS Number: 78919‐13‐8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.02‐ Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use CONDITION: Cheyne‐Stokes respiration ; MedDRA version: 12.1 Level: LLT Classification code 10055576 Term: Central sleep apnea syndrome PRIMARY OUTCOME: Main Objective: Elevated pulmonary capillary wedge pressure (PCWP) is assumed a main cause of Cheyne‐Stokes respiration. Aim of this study therefore is to investigate whether lowering of PCWP is associated with an improvement in severity of Cheyne‐Stokes respiration. Primary end point(s): Changes in Apnoea‐Hypopnoea‐Index during glycerol trinitrate/Iloprost‐Infusion Secondary Objective: Relationship between changes in hemodynamic parameters (PCWP, pulmonary artery pressure, cardiac index) and changes in severity of Cheyne‐Stokes respiration. INCLUSION CRITERIA: ‐ moderate to severe Cheyne‐Stokes respiration (Apnoea‐Hypopnoea‐Index = 15/h) ‐ Age = 18 years ‐ Stabile Medication for at least 4 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 587d5e751665e4fd9977631f47cb31c05bc5c57a
First added on: Aug 22, 2024