Prospective evaluation of additional nitrate therapy in patients with congestive heart failure and Cheyne-Stokes respiratio

Phase 2

Conditions: I50.1
R06.3
Left ventricular failure
Periodic breathing

Registration Number: DRKS00000402

Lead Sponsor: Kardiologische Klinik, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting withdrawn before recruiting started

Sex: All

Target Recruitment: 0

Inclusion Criteria

Congestive heart failure, diagnosed at least 8 weeks before
- functional NYHA-class II-III
- LVEF <46%
- Cheyne-Stokes Respiration (AHI >14/h)

Exclusion Criteria

- Hypotension (RR<90/60mmHg)
- Ongoing nitrate therapy
- ICD, CRT or pacemaker implantation within the last 6 months
- COPD (FEV1/FVC<70%)
- Respiratory insufficiency requiring oxygen-therapy
- Daytime hypercapnia (pCO2>45mmHg)
- Cardiothoracic surgery or PCI within the last 3 monsth
- myocardial infarction, unstable angina pectoris, transitoric ischemic attack (TIA), or stroke within the last 12 weeks
- renal failure (> stadium III)
- therapy lacking or therapy-refractory restless-legs-syndrome
- pregnancy
- ongoing ventilation therapy
- acute myocarditis within the last 6 months

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
50% Reduction in Apnoea-Hypopnoea Index, compared with the observational night, measured by full-inhospital polysomnography.

Secondary Outcome Measures

Name	Time	Method
- Correlation of changes in Apnoea-Hypopnoea-Index with changes in Pulmonary Artey Pressure and Pulmonary Capillary Wedge Pressure<br>- Changes in arousalindex<br>- Changes in desaturations <br>- Nocturnal changes in ANP, BNP and Endothelin-1