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The aim of the study is to compare the effects of torasemide and furosemide on clinical and biochemical parameters of hemodynamic and neurohormonal compensation and myocardial remodeling in patients with chronic heart failure with indications for use of loop diuretics.
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.
According to current guidelines, angiotensin converting enzyme inhibitors and beta-adrenolytics are the first-line treatment agents in patients with heart failure. In case of fluid retention, diuretics, as a part of symptomatic treatment, should be administered. In practice, the most common diuretic used in patients with heart failure is loop diuretic - furosemide. What is important, furosemide has no effect on patients' outcomes. Some studies showed unfavourable influence of this drug on rennin-angiotensin-aldosterone system.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furosemide | Active Comparator | This group will receive furosemide as a diuretic treatment |
|
| Torasemide | Experimental | This group will receive torasemide as a diuretic treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The influence of therapy on cardiovascular events associated with heart failure (deaths, hospitalisations) | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The change of dosing of diuretic due to worsening of condition of patient. | up to 12 months | |
| The change of NYHA (New York Heart Association) class - worsening or improvement | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The measurement of fluid retention with ZOE Fluid Status Monitor | up to 12 months | |
| ≥30% or ≥200 pg/ml increase of NTproBNP (N-terminal pro B type natriuretic peptide) level compared with baseline value | up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcin Grabowski, PhD | Contact | +48 660 751 816 | marcin.grabowski@wum.edu.pl | |
| Paweł Balsam, PhD | Contact | +48 605152120 | pawel.balsam@me.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcin Grabowski, PhD | 1st Department of Cardiology Medical University of Warsaw | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3rd Clinic of Internal Medicine and Cardiology of Medcial University of Warsaw | Not yet recruiting | Warsaw | Masovian Voivodeship | 00-382 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28114980 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D000077786 | Torsemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Torasemide | Drug | 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 |
|
| The change between baseline and final levels of serum biomarkers | up to 12 months |
| The assessment of quality of life | up to 12 months |
| 1st Department of Cariology of Medcial University of Warsaw | Recruiting | Warsaw | Masovian Voivodeship | 02-097 | Poland |
|
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |