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

ISRCTN	ISRCTN43596477
DOI	https://doi.org/10.1186/ISRCTN43596477
Protocol serial number	N/A
Sponsor	University Hospital Basel (Switzerland)
Funders	Horten Foundation (Switzerland), Unrestricted grants from different pharmaceutical companies:, AstraZeneca Schweiz, Novartis, Pfizer UK, A. Menarini Industrie Farmaceutiche Riunite Srl (Italy), Institut de Recherches Internationales Servier (France), Roche, Roche Diagnostics AG (Switzerland), 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.

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Matthias Pfisterer
Scientific

Div. of Cardiology
University Hospital
Petersgraben 4
Basel
4031
Switzerland

Phone	+41 (0)61 265 52 14
Email	pfistererm@uhbs.ch

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure
Study acronym	TIME-CHF
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. All cause hospitalisation free survival after 18 months 2. Quality of life after 18 months
Key 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
Completion date	31/05/2008

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	820
Key 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)
Key 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
Date of first enrolment	01/12/2002
Date of final enrolment	31/05/2008

University Hospital

Basel
4031
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/01/2009		Yes	No
Results article	results	01/03/2012		Yes	No
Results article	results	01/03/2012		Yes	No
Results article	results	01/02/2013		Yes	No
Results article	results	01/06/2013		Yes	No
Results article	results	01/08/2013		Yes	No
Results article	results	01/10/2013		Yes	No
Results article	results	01/01/2014		Yes	No
Results article	results	01/04/2015		Yes	No
Results article	results	15/07/2015		Yes	No
Results article	results	01/10/2015		Yes	No
Results article	results	08/08/2016		Yes	No
Protocol article	protocol	01/05/2006		Yes	No
Other publications	post hoc analysis	13/05/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

14/06/2018: Publication reference added.
10/08/2016: Publication references added.