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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
5. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24352403
6. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23384944
7. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23666681
8. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24621800
9. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23657728
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
  Email 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
  Email brunnerh@uhbs.ch
Date applied 12/08/2005
Last edited 08/05/2014
Date ISRCTN assigned 23/09/2005
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