PMID- 23666681
OWN - NLM
STAT- MEDLINE
DCOM- 20140310
LR  - 20130725
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Linking)
VI  - 15
IP  - 8
DP  - 2013 Aug
TI  - 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.
PG  - 910-8
LID - 10.1093/eurjhf/hft079 [doi]
AB  - AIMS: NT-proBNP-guided therapy results in intensification of medical heart 
      failure (HF) therapy and is suggested to improve outcome. However, it is feared 
      that an intensified, NT-proBNP-guided therapy carries a risk of adverse effects. 
      Therefore, the safety and tolerability of NT-proBNP-guided therapy in the Trial 
      of Intensified vs standard Medical therapy in Elderly patients with Congestive 
      Heart Failure (TIME-CHF) was assessed. METHODS AND RESULTS: A total of 495 
      chronic HF patients, aged >/=60, with an LVEF </=45%, NYHA class >/=II, randomized to 
      NT-proBNP-guided or symptom-guided therapy and >/=1 month follow-up were included 
      in the present safety analysis. All adverse events (AEs) were recorded during the 
      18-month trial period. A total of 5212 AEs were noted, 433 of them serious. 
      NT-proBNP-guided therapy led to a higher up-titration of HF medication and was 
      well tolerated, with a dropout rate (12% vs. 11%, P = 1.0) and AE profile [number 
      of AEs/patient-year 4.7 (2.8-9.4) vs. 5.4 (2.7-11.4), P = 0.69; number of severe 
      AEs/patient-year 0.7 (0-2.7) vs. 1.3 (0-3.9), P = 0.21] similar to that of 
      symptom-guided therapy, although most subjects in both treatment groups (96% vs. 
      95%, P = 0.55) experienced at least one AE. Age and number of co-morbidities were 
      associated with AEs and interacted with the safety profile of NT-proBNP-guided 
      therapy: positive effects were more frequent in younger and less co-morbid 
      patients whereas potential negative effects-although small and related to 
      non-severe AEs only-were only seen in the older and more co-morbid patients. 
      CONCLUSIONS: NT-proBNP-guided therapy is safe in elderly and highly co-morbid HF 
      patients. Trial registration ISRCTN43596477.
FAU - Sanders-van Wijk, Sandra
AU  - Sanders-van Wijk S
AD  - Maastricht University Medical Center, CARIM, Maastricht, The Netherlands. 
      sandra.van.wijk@mumc.nl
FAU - Muzzarelli, Stefano
AU  - Muzzarelli S
FAU - Neuhaus, Michael
AU  - Neuhaus M
FAU - Kiencke, Stephanie
AU  - Kiencke S
FAU - Maeder, Micha
AU  - Maeder M
FAU - Estlinbaum, Werner
AU  - Estlinbaum W
FAU - Tobler, Daniel
AU  - Tobler D
FAU - Mayer, Kurt
AU  - Mayer K
FAU - Erne, Paul
AU  - Erne P
FAU - Pfisterer, Matthias E
AU  - Pfisterer ME
FAU - Brunner-La Rocca, Hans-Peter
AU  - Brunner-La Rocca HP
CN  - TIME-CHF investigators
LA  - eng
SI  - ISRCTN/ISRCTN43596477
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130510
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
RN  - 0 (Adrenergic beta-Antagonists)
RN  - 0 (Angiotensin Receptor Antagonists)
RN  - 0 (Angiotensin-Converting Enzyme Inhibitors)
RN  - 0 (Diuretics)
RN  - 0 (Peptide Fragments)
RN  - 0 (Sodium Potassium Chloride Symporter Inhibitors)
RN  - 0 (pro-brain natriuretic peptide (1-76))
RN  - 114471-18-0 (Natriuretic Peptide, Brain)
RN  - 27O7W4T232 (Spironolactone)
SB  - IM
CIN - Eur J Heart Fail. 2013 Aug;15(8):832-4. PMID: 23821462
MH  - Adrenergic beta-Antagonists/*therapeutic use
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiotensin Receptor Antagonists/*therapeutic use
MH  - Angiotensin-Converting Enzyme Inhibitors/*therapeutic use
MH  - Diuretics/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Drug Therapy/methods
MH  - Female
MH  - Heart Failure/blood/*drug therapy
MH  - Humans
MH  - Male
MH  - Natriuretic Peptide, Brain/*blood
MH  - Peptide Fragments/*blood
MH  - Sodium Potassium Chloride Symporter Inhibitors/*therapeutic use
MH  - Spironolactone/*therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Ageing
OT  - Co-morbidities
OT  - Drug therapy
OT  - Heart failure
OT  - Natriuretic peptide
OT  - Safety
EDAT- 2013/05/15 06:00
MHDA- 2014/03/13 06:00
CRDT- 2013/05/14 06:00
PHST- 2013/05/14 06:00 [entrez]
PHST- 2013/05/15 06:00 [pubmed]
PHST- 2014/03/13 06:00 [medline]
AID - hft079 [pii]
AID - 10.1093/eurjhf/hft079 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2013 Aug;15(8):910-8. doi: 10.1093/eurjhf/hft079. Epub 2013 May 
      10.