Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Matthias Pfisterer

ORCID ID

Contact details

Div. of Cardiology
University Hospital
Petersgraben 4
Basel
4031
Switzerland
+41 61 265 52 14
pfistererm@uhbs.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

TIME-CHF

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Congestive heart failure

Intervention

Medical therapy of congestive heart failure as defined in current guidelines, either guided by symptoms only or symptoms and NT-BNP levels

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. All cause hospitalisation free survival after 18 months
2. Quality of life after 18 months

Secondary outcome measures

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

Overall trial start date

01/12/2002

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

820

Participant 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

Recruitment start date

01/12/2002

Recruitment end date

31/05/2008

Locations

Countries of recruitment

Switzerland

Trial participating centre

Div. of Cardiology
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

Div. of Cardiology
Petersgraben 4
Basel
4031
Switzerland
+41 61 265 29 48
brunnerh@uhbs.ch

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Horten Foundation (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Unrestriced grants from different pharmaceutical companies:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

AstraZeneca AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Novartis Pharma AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

A. Menarini Industrie Farmaceutiche Riunite Srl (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Roche Pharma Ltd (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Roche Diagnostics AG (Switzerland)

Alternative name(s)

Funding Body Type

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Location

Funder name

Merck AG (Switzerland)

Alternative name(s)

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Location

Funder name

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.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication 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

Publication citations

  1. Protocol

    Brunner-La Rocca HP, Buser PT, Schindler R, Bernheim A, Rickenbacher P, Pfisterer M, , Management of elderly patients with congestive heart failure--design of the Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure (TIME-CHF)., Am. Heart J., 2006, 151, 5, 949-955, doi: 10.1016/j.ahj.2005.10.022.

  2. Results

    Pfisterer M, Buser P, Rickli H, Gutmann M, Erne P, Rickenbacher P, Vuillomenet A, Jeker U, Dubach P, Beer H, Yoon SI, Suter T, Osterhues HH, Schieber MM, Hilti P, Schindler R, Brunner-La Rocca HP, , BNP-guided vs symptom-guided heart failure therapy: the Trial of Intensified vs Standard Medical Therapy in Elderly Patients With Congestive Heart Failure (TIME-CHF) randomized trial., JAMA, 2009, 301, 4, 383-392, doi: 10.1001/jama.2009.2.

  3. Results

    Brunner-La Rocca HP, Rickenbacher P, Muzzarelli S, Schindler R, Maeder MT, Jeker U, Kiowski W, Leventhal ME, Pfister O, Osswald S, Pfisterer ME, Rickli H, , End-of-life preferences of elderly patients with chronic heart failure., Eur. Heart J., 2012, 33, 6, 752-759, doi: 10.1093/eurheartj/ehr404.

  4. Results

    Maeder MT, Rickli H, Pfisterer ME, Muzzarelli S, Ammann P, Fehr T, Hack D, Weilenmann D, Dieterle T, Kiencke S, Estlinbaum W, Brunner-La Rocca HP, , Incidence, clinical predictors, and prognostic impact of worsening renal function in elderly patients with chronic heart failure on intensive medical therapy., Am. Heart J., 2012, 163, 3, 407-14, 414.e1, doi: 10.1016/j.ahj.2011.12.003.

  5. Results

    Sanders-van Wijk S, Maeder MT, Nietlispach F, Rickli H, Estlinbaum W, Erne P, Rickenbacher P, Peter M, Pfisterer MP, Brunner-La Rocca HP, , Long-term results of intensified, N-terminal-pro-B-type natriuretic peptide-guided versus symptom-guided treatment in elderly patients with heart failure: five-year follow-up from TIME-CHF., Circ Heart Fail, 2014, 7, 1, 131-139, doi: 10.1161/CIRCHEARTFAILURE.113.000527.

  6. Results

    Huijts M, van Oostenbrugge RJ, Duits A, Burkard T, Muzzarelli S, Maeder MT, Schindler R, Pfisterer ME, Brunner-La Rocca HP, , Cognitive impairment in heart failure: results from the Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure (TIME-CHF) randomized trial., Eur. J. Heart Fail., 2013, 15, 6, 699-707, doi: 10.1093/eurjhf/hft020.

  7. Results

    Sanders-van Wijk S, Muzzarelli S, Neuhaus M, Kiencke S, Maeder M, Estlinbaum W, Tobler D, Mayer K, Erne P, Pfisterer ME, Brunner-La Rocca HP, , Safety and tolerability of intensified, N-terminal pro brain natriuretic peptide-guided compared with standard medical therapy in elderly patients with congestive heart failure: results from TIME-CHF., Eur. J. Heart Fail., 2013, 15, 8, 910-918, doi: 10.1093/eurjhf/hft079.

  8. Results

    Sanders-van Wijk S, van Asselt AD, Rickli H, Estlinbaum W, Erne P, Rickenbacher P, Vuillomenet A, Peter M, Pfisterer ME, Brunner-La Rocca HP, , Cost-effectiveness of N-terminal pro-B-type natriuretic-guided therapy in elderly heart failure patients: results from TIME-CHF (Trial of Intensified versus Standard Medical Therapy in Elderly Patients with Congestive Heart Failure)., JACC Heart Fail, 2013, 1, 1, 64-71, doi: 10.1016/j.jchf.2012.08.002.

  9. Results

    Maeder MT, Rickenbacher P, Rickli H, Abbühl H, Gutmann M, Erne P, Vuilliomenet A, Peter M, Pfisterer M, Brunner-La Rocca HP, , N-terminal pro brain natriuretic peptide-guided management in patients with heart failure and preserved ejection fraction: findings from the Trial of Intensified versus standard medical therapy in elderly patients with congestive heart failure (TIME-CHF)., Eur. J. Heart Fail., 2013, 15, 10, 1148-1156, doi: 10.1093/eurjhf/hft076.

Editorial Notes