Trial of intensified versus standard medical therapy in elderly patients with congestive heart failure

Not Applicable

Completed

• Conditions: Congestive heart failure; Circulatory System

• Registration Number: ISRCTN43596477
• Lead Sponsor: niversity Hospital Basel (Switzerland)

Brief Summary

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 10. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25576682 11. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25981371 12. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26472682 13. 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27503849 14. 2018 post hoc analysis in: http://www.ncbi.nlm.nih.gov/pubmed/29896315

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-23
• Study Completion: 2008-05-31
• Last Update Posted: 2 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 820

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. All cause hospitalisation free survival after 18 months<br>2. Quality of life after 18 months

Secondary Outcome Measures

Name	Time	Method
1. Primary endpoints after 12 months<br>2. Components of primary endpoints<br>3. Overall costs and use of health care resources<br>4. Cost-effectiveness<br>5. Patients' preferences regarding treatment<br>6. Effects of baseline characteristics on outcome<br>7. Prediction of tolerability and effect of medication