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21 May 2012
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| [ Print-friendly version ] |
| Disease manifestation and disease management in chronic heart failure |
| ISRCTN | ISRCTN23325295 |
| ClinicalTrials.gov identifier | |
| Public title | Disease manifestation and disease management in chronic heart failure |
| Scientific title | A standardised multidisciplinary disease management programme improves mortality and morbidity in patients with systolic heart failure - the Interdisciplinary Network for Heart failure (INH) Study |
| Acronym | INH-Study |
| Serial number at source | N/A |
| Study hypothesis |
Network care when compared to usual care reduces mortality and hospitalisation (combined primary end point) and/or improves quality of life 6 months after randomisation.
Please note that extensive amendments have been made to this ISRCTN record as of 20/08/2009. They include the following: 1. Scientific title was added 2. Target number of participants was changed from 700 to 1,000 3. Trial end date was updated from 31/12/2006 to 30/09/2009 All other changes are recorded in the relevant fields. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Ethics Committee of the Faculty of Mecidine, University of Würzburg (Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg), approved on 09 January 2004 (ref: 130/03) |
| Study design | Two-arm parallel-group randomised intervention study |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Chronic heart failure |
| Participants - inclusion criteria |
1. Age >18 years
2. Written informed consent 3. Heart failure documented by reduced left ventricular ejection fraction (<=40%) during hospitalisation and clinical signs/symptoms of heart failure (peripheral edema, pulmonary edema, rales, pulmonary congestion confirmed by X-ray, elevated jugular venous pressure, exertional dyspnea) |
| Participants - exclusion criteria |
1. Insufficient mental or verbal or physical ability to participate in a telephone assisted monitoring and education program
2. No telephone line installed |
| Anticipated start date | 01/03/2004 |
| Anticipated end date | 30/09/2009 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 1,000 |
| Interventions |
This is a 2-arm parallel group randomised intervention study. Patients are randomised 1:1 into network care and usual care. Intensified patient care and management (i.e. network care) is characterised by:
1. Telephone based symptom-oriented patient monitoring following a predefined algorithm depending on the severity of the condition 2. Telephone based patient-oriented education and training regarding heart failure manifestation, diet, psychological dimensions |
| Primary outcome measure(s) |
Current primary outcome measure as of 20/08/2009:
1. Death of any cause or hospitalisation of any cause (combined endpoint) Previous primary outcome measures: 1. Death of any cause or hospitalisation of any cause (combined endpoint) 2. Quality of life |
| Secondary outcome measure(s) |
Current secondary outcome measures as of 20/08/2009:
1. Components of composite primary endpoint 2. Cardiovascular death 3. Cardiovascular hospitalisation 4. Proportion of patients treated in adherence with current heart failure treatment guidelines 2. Quality of life 5. Cost-effectiveness analyses Previous secondary outcome measures: 1. Components of composite primary endpoint 2. Cardiovascular death 3. Cardiovascular hospitalisation 4. Proportion of patients treated in adherence with current heart failure treatment guidelines 5. Cost-effectiveness analyses |
| Sources of funding |
1. German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]).
2. Head Organisation of non-private health insurances (Spitzenverbände der gesetzlichen Krankenkassen). Added on 24/08/2009: Additional funding was received from the German Competence Network Heart Failure for the 'extended INH-Study' in 2006 and 2009. |
| Trial website | |
| Publications |
1. 2009 publication (in German) on the interventions used in this study in http://www.ncbi.nlm.nih.gov/pubmed/19340758
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21956192 |
| Contact name | Prof Christiane E Angermann |
| Address | Klinikstrasse 6-8 |
| City/town | Wuerzburg |
| Zip/Postcode | 97070 |
| Country | Germany |
| Tel | +49 (0)931 201 70460 |
| Fax | +49 (0)931 201 71240 |
| angermann_c@klinik.uni-wuerzburg.de | |
| Sponsor | University of Wuerzburg (Germany) |
| Address | Sanderring 2 |
| City/town | Wuerzburg |
| Zip/Postcode | 97070 |
| Country | Germany |
| Tel | +49 (0)931 31 2231 |
| Fax | +49 (0)931 31 2100 |
| kanzler@zv.uni-wuerzburg.de | |
| Date applied | 21/09/2005 |
| Last edited | 18/04/2012 |
| Date ISRCTN assigned | 30/11/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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