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| [ Print-friendly version ] |
| Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure |
| ISRCTN | ISRCTN43596477 |
| DOI | 10.1186/ISRCTN43596477 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure |
| Scientific title | |
| Acronym | TIME-CHF |
| Serial number at source | N/A |
| Study hypothesis | Intensified, N-terminal B-type natriuretic peptide (NT-BNP) guided therapy is more effective than standard, symptom guided therapy in Congestive Heart Failure (CHF) patients aged greater than or equal to 75 years as compared to CHF patients aged 60 - 74 years. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Switzerland |
| Disease/condition/study domain | Congestive heart failure |
| Participants - inclusion criteria |
1. Heart failure patients aged greater than 60 years
2. New York Heart Association (NYHA) greater than or equal to II 3. CHF hospitalisation within last year 4. NT-BNP level greater than 800 pg/ml (greater than or equal to 75 years), 400 pg/ml (60 - 74 years) |
| Participants - exclusion criteria |
1. Serum creatinine greater than 220 µmol/l
2. Valve disease needing surgery 3. Disease other than cardiovascular limiting life-expectancy less than 3 years 4. No informed consent |
| Anticipated start date | 01/12/2002 |
| Anticipated end date | 31/05/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 820 |
| Interventions | Medical therapy of congestive heart failure as defined in current guidelines, either guided by symptoms only or symptoms and NT-BNP levels |
| Primary outcome measure(s) |
1. All cause hospitalisation free survival after 18 months
2. Quality of life after 18 months |
| Secondary outcome measure(s) |
1. Primary endpoints after 12 months
2. Components of primary endpoints 3. Overall costs and use of health care resources 4. Cost-effectiveness 5. Patients' preferences regarding treatment 6. Effects of baseline characteristics on outcome 7. Prediction of tolerability and effect of medication |
| Sources of funding |
Horten foundation (Switzerland)
Unrestriced grants from different pharmaceutical companies: 1. AstraZeneca AG (Switzerland) 2. Novartis Pharma AG (Switzerland) 3. Pfizer Ltd (UK) 4. A. Menarini Industrie Farmaceutiche Riunite Srl (Italy) 5. Institut de Recherches Internationales Servier (France) 6. Roche Pharma Ltd (Switzerland) 7. Roche Diagnostics AG (Switzerland) 8. Merck AG (Switzerland) Please note that these unrestricted grants cover only a part of the study costs (total approx 33%). The financial contribution is not the same for all companies. |
| Trial website | |
| Publications |
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16644310
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19176440 3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22067089 4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22424011 |
| Contact name | Prof Matthias Pfisterer |
| Address |
Div. of Cardiology
University Hospital Petersgraben 4 |
| City/town | Basel |
| Zip/Postcode | 4031 |
| Country | Switzerland |
| Tel | +41 61 265 52 14 |
| Fax | +41 61 265 45 98 |
| pfistererm@uhbs.ch | |
| Sponsor | University Hospital Basel (Switzerland) |
| Address |
Div. of Cardiology
Petersgraben 4 |
| City/town | Basel |
| Zip/Postcode | 4031 |
| Country | Switzerland |
| Tel | +41 61 265 29 48 |
| Fax | +41 61 265 78 84 |
| brunnerh@uhbs.ch | |
| Date applied | 12/08/2005 |
| Last edited | 17/05/2012 |
| Date ISRCTN assigned | 23/09/2005 |
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| © 2013 ISRCTN unless otherwise stated. | |
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