The Impact of TORasemide oN hemodynAmic and Neurohormonal Stress, and carDiac remOdeling in Heart Failure
NCT ID: NCT01942109
Last Updated: 2017-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2013-09-30
2018-12-31
Brief Summary
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The study protocol 100 patients with heart failure NYHA (New York Heart Association) II-IV (stable or exacerbation aligned cardiopulmonary at the time of enrollment, with a fixed-dose loop diuretics\]) treated with optimal medical therapy as clinically indicated for use loop diuretics. Patients will be randomized to treatment with furosemide and torasemide (randomization 1 : 1). After randomization, furosemide will continue in its current fixed-dose or will be replaced by equipotential dose of torasemide (4:1). The minimal follow-up of patients in the study will be at least six months.
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Detailed Description
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Alternative loop diuretic, which may be administered in patients with heart failure is torasemide. Its longer elimination half-life time, similar diuretic effects, lower influence on electrolyte disorders and additional pleiotropic effects could make torasemide more beneficial than furosemide.
Accordingly, only direct comparison of furosemide and torasemide could present similarities and differences of these two agents.
The hypothesis of this study is that torasemide may present more favourable effects on some clinical parameters in patients with heart failure, than furosemide (e.g. clinical symptoms, biochemical parameters, activity of rennin-angiotensin-aldosterone system, side effects).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Furosemide
This group will receive furosemide as a diuretic treatment
Furosemide
Drug will be administered per os. Dose of the agent will be adapted to clinical status of the patient. Equipotential dose for furosemide is torasemide in dose 1:4 of furosemide
Torasemide
This group will receive torasemide as a diuretic treatment
Torasemide
Drug will be administered per os. Dose of the agent will be adapted to clinical status of the patient. Equipotential dose for furosemide is torasemide in dose 1:4 of furosemide
Interventions
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Furosemide
Drug will be administered per os. Dose of the agent will be adapted to clinical status of the patient. Equipotential dose for furosemide is torasemide in dose 1:4 of furosemide
Torasemide
Drug will be administered per os. Dose of the agent will be adapted to clinical status of the patient. Equipotential dose for furosemide is torasemide in dose 1:4 of furosemide
Eligibility Criteria
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Inclusion Criteria
* previous treatment with diuretics
* age\>18 years
Exclusion Criteria
* uncontrolled diabetes
* creatinine \> 2,5 mg/dl
* potassium \> 6 mg/dl
* acute coronary syndrome
* hypertrophic cardiomyopathy
18 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Marcin Grabowski
PhD
Principal Investigators
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Marcin Grabowski, PhD
Role: STUDY_CHAIR
1st Department of Cardiology Medical University of Warsaw
Locations
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3rd Clinic of Internal Medicine and Cardiology of Medcial University of Warsaw
Warsaw, Masovian Voivodeship, Poland
1st Department of Cariology of Medcial University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Balsam P, Ozieranski K, Tyminska A, Glowczynska R, Peller M, Fojt A, Cacko A, Sieradzki B, Bakula E, Markulis M, Kowalik R, Huczek Z, Filipiak KJ, Opolski G, Grabowski M. The impact of torasemide on haemodynamic and neurohormonal stress, and cardiac remodelling in heart failure - TORNADO: a study protocol for a randomized controlled trial. Trials. 2017 Jan 23;18(1):36. doi: 10.1186/s13063-016-1760-z.
Other Identifiers
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TORNADO KB/202/2013
Identifier Type: -
Identifier Source: org_study_id
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