Cheyne-Stokes respiration MedDRA version: 12.1 Level: LLT Classification code 10055576 Term: Central sleep apnea syndrome
Conditions
Interventions
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
Sponsors
Herz- & Diabeteszentrum NRW
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: - Ongoing nitrate-therapy - Hypotension (RR 45 mmHg) - Ongoing ventilation therapy - Cardiothoracic surgery within the last 3 months - Myocardial infarction within the last 6 months - Instable angina, transitoric ischaemic attac or stroke within the last 12 weeks - Epilepsy, known cerebral damage, dementia - Untreated Restless-legs-syndrom - Acute Myocarditis - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: Relationship between changes in hemodynamic parameters (PCWP, pulmonary artery pressure, cardiac index) and changes in severity of Cheyne-Stokes respiration.;Primary end point(s): Changes in Apnoea-Hypopnoea-Index during glycerol trinitrate/Iloprost-Infusion | — |
Countries
Germany
Outcome results
None listed