Skip to content

The Impact of TORasemide oN hemodynAmic and Neurohormonal Stress, and carDiac remOdeling in Heart Failure

The Impact of TORasemide oN hemodynAmic and Neurohormonal Stress, and carDiac remOdeling in Heart Failure - Prospective, Randomized, Open, Blinded Endpoint Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01942109
Acronym
TORNADO
Enrollment
100
Registered
2013-09-13
Start date
2013-09-30
Completion date
2018-12-31
Last updated
2017-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, diuretics, furosemide, torasemide

Brief summary

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.

Detailed description

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).

Interventions

DRUGFurosemide

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

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

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* heart failure NYHA II-IV * previous treatment with diuretics * age\>18 years

Exclusion criteria

* uncontrolled hypertension * uncontrolled diabetes * creatinine \> 2,5 mg/dl * potassium \> 6 mg/dl * acute coronary syndrome * hypertrophic cardiomyopathy

Design outcomes

Primary

MeasureTime frame
The influence of therapy on cardiovascular events associated with heart failure (deaths, hospitalisations)up to 12 months

Secondary

MeasureTime 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 improvementup to 12 months

Other

MeasureTime frame
The measurement of fluid retention with ZOE Fluid Status Monitorup to 12 months
The assessment of quality of lifeup to 12 months
≥30% or ≥200 pg/ml increase of NTproBNP (N-terminal pro B type natriuretic peptide) level compared with baseline valueup to 12 months
The change between baseline and final levels of serum biomarkersup to 12 months

Countries

Poland

Contacts

Primary ContactMarcin Grabowski, PhD
marcin.grabowski@wum.edu.pl+48 660 751 816
Backup ContactPaweł Balsam, PhD
pawel.balsam@me.com+48 605152120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026