PMID- 28114980
OWN - NLM
STAT- MEDLINE
DCOM- 20180305
LR  - 20181202
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 18
IP  - 1
DP  - 2017 Jan 23
TI  - The impact of torasemide on haemodynamic and neurohormonal stress, and cardiac 
      remodelling in heart failure - TORNADO: a study protocol for a randomized 
      controlled trial.
PG  - 36
LID - 10.1186/s13063-016-1760-z [doi]
LID - 36
AB  - BACKGROUND: Approximately 50% of heart failure patients are readmitted to 
      hospital within 6 months, owing to deterioration of their condition. Thus, 
      symptomatic treatment of heart failure requires significant improvement. The aim 
      of this study is to compare the effects of torasemide and furosemide on 
      biochemical parameters of haemodynamic and neurohormonal compensation, myocardial 
      remodelling, clinical outcomes and quality of life in patients with chronic heart 
      failure. METHODS: This is a multicentre, randomized, open, blinded endpoint 
      phase-IV trial. The study includes 120 heart failure patients in NYHA (New York 
      Heart Association) functional class II-IV, treated with optimal heart failure 
      therapy, with indications for use of loop diuretics. At enrolment, patients are 
      stable, with a fixed dose of loop diuretics. Patients are randomized to treatment 
      with furosemide or torasemide (randomization 1:1). After randomization, the 
      current fixed dose of furosemide is continued or is replaced by an equipotential 
      dose of torasemide (4:1). The study consists of two control visits (3 and 
      6 months after enrolment) with minimal follow-up of 6 months. Assessment involves 
      clinical examination, Quality of Life Questionnaire, laboratory tests, 
      echocardiography, electrocardiography, 24 h Holter-electrocardiography 
      monitoring, 6 -min walk test and assessment of fluid retention. Any need for dose 
      adjustment is assessed during the observation. The primary objective is to 
      compare the effects of torasemide and furosemide on clinical and biochemical 
      parameters of haemodynamic and neurohormonal compensation and myocardial 
      remodelling. Secondary objectives include monitoring of: changes in signs and 
      symptoms of heart failure, NYHA functional class, quality of life, dosage 
      changes, rate of readmissions and mortality. DISCUSSION: Despite decades of the 
      diuretic's history, knowledge about diuretic therapy is still unsatisfactory. The 
      most widely used diuretic, furosemide, has a stormy pharmacokinetics and 
      pharmacodynamics, and is associated with a high risk of mortality and 
      hospitalization for worsening heart failure. Reports are very encouraging and 
      suggest beneficial effects of torasemide. Hence, there is a need for further 
      studies of the overall effect of torasemide, compared with furosemide. This can 
      translate into improved quality of life and better prognosis of patients with 
      heart failure. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01942109 . Registered 
      on 24 August 2013.
FAU - Balsam, Pawel
AU  - Balsam P
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland. 
      pawel.balsam@me.com.
FAU - Ozieranski, Krzysztof
AU  - Ozieranski K
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Tyminska, Agata
AU  - Tyminska A
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Glowczynska, Renata
AU  - Glowczynska R
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Peller, Michal
AU  - Peller M
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Fojt, Anna
AU  - Fojt A
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Cacko, Andrzej
AU  - Cacko A
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Sieradzki, Bartosz
AU  - Sieradzki B
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Bakula, Elwira
AU  - Bakula E
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Markulis, Maciej
AU  - Markulis M
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Kowalik, Robert
AU  - Kowalik R
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Huczek, Zenon
AU  - Huczek Z
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Filipiak, Krzysztof J
AU  - Filipiak KJ
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Opolski, Grzegorz
AU  - Opolski G
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
FAU - Grabowski, Marcin
AU  - Grabowski M
AD  - 1st Chair and Department of Cardiology, Medical University of Warsaw, Public 
      Central Teaching Hospital in Warsaw, 1a Banacha St., Warsaw, 02-097, Poland.
LA  - eng
SI  - ClinicalTrials.gov/NCT01942109
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170123
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Biomarkers)
RN  - 0 (Neurotransmitter Agents)
RN  - 0 (Sodium Potassium Chloride Symporter Inhibitors)
RN  - 0 (Sulfonamides)
RN  - 7LXU5N7ZO5 (Furosemide)
RN  - W31X2H97FB (Torsemide)
SB  - IM
MH  - Biomarkers/blood
MH  - Chronic Disease
MH  - Clinical Protocols
MH  - Echocardiography
MH  - Electrocardiography, Ambulatory
MH  - Furosemide/adverse effects/*therapeutic use
MH  - Heart Failure/blood/diagnosis/*drug therapy/physiopathology
MH  - Hemodynamics/*drug effects
MH  - Humans
MH  - Neurotransmitter Agents/*blood
MH  - Poland
MH  - Quality of Life
MH  - Recovery of Function
MH  - Research Design
MH  - Sodium Potassium Chloride Symporter Inhibitors/adverse effects/*therapeutic use
MH  - Sulfonamides/adverse effects/*therapeutic use
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Torsemide
MH  - Treatment Outcome
MH  - Ventricular Remodeling/*drug effects
MH  - Walk Test
PMC - PMC5259911
OTO - NOTNLM
OT  - Dose
OT  - Furosemide
OT  - Heart failure
OT  - Hospitalization
OT  - Loop diuretic
OT  - Prognosis
OT  - Quality of life
OT  - Randomized controlled trial
OT  - Torasemide
EDAT- 2017/01/25 06:00
MHDA- 2018/03/06 06:00
PMCR- 2017/01/23
CRDT- 2017/01/25 06:00
PHST- 2016/07/27 00:00 [received]
PHST- 2016/12/16 00:00 [accepted]
PHST- 2017/01/25 06:00 [entrez]
PHST- 2017/01/25 06:00 [pubmed]
PHST- 2018/03/06 06:00 [medline]
PHST- 2017/01/23 00:00 [pmc-release]
AID - 10.1186/s13063-016-1760-z [pii]
AID - 1760 [pii]
AID - 10.1186/s13063-016-1760-z [doi]
PST - epublish
SO  - Trials. 2017 Jan 23;18(1):36. doi: 10.1186/s13063-016-1760-z.