Trial of intensified versus standard medical therapy in elderly patients with congestive heart failure
| ISRCTN | ISRCTN43596477 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43596477 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/08/2005
- Registration date
- 23/09/2005
- Last edited
- 14/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Matthias Pfisterer
Scientific
Scientific
Div. of Cardiology
University Hospital
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 (0)61 265 52 14 |
|---|---|
| pfistererm@uhbs.ch |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a 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 | 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 study start date | 01/12/2002 |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Hospital
Basel
4031
Switzerland
4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
University/education
University/education
Div. of Cardiology
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 (0)61 265 29 48 |
|---|---|
| brunnerh@uhbs.ch | |
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Charity
Horten Foundation (Switzerland)
No information available
Unrestricted grants from different pharmaceutical companies:
No information available
AstraZeneca Schweiz
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca Suisse, AstraZeneca Svizzera, AstraZeneca Switzerland, AZ
- Location
- Switzerland
Novartis
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Novartis AG, Novartis International AG
- Location
- Switzerland
Pfizer UK
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Ltd, Pfizer Limited
- Location
- United Kingdom
A. Menarini Industrie Farmaceutiche Riunite Srl (Italy)
No information available
Institut de Recherches Internationales Servier (France)
No information available
Roche
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG, Roche Holding AG, Roche Holding Ltd, Roche Holding, Roche Holding A.G., Roche Holding, Limited, F. Hoffmann-La Roche & Co.
- Location
- Switzerland
Roche Diagnostics AG (Switzerland)
No information available
Merck AG (Switzerland)
No information available
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.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/05/2006 | Yes | No | |
| 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 | |
| Other publications | post hoc analysis | 13/05/2018 | Yes | No |
Editorial Notes
14/06/2018: Publication reference added.
10/08/2016: Publication references added.
