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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Furosemide

This group will receive furosemide as a diuretic treatment

Group Type ACTIVE_COMPARATOR

Furosemide

Intervention Type 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

Torasemide

This group will receive torasemide as a diuretic treatment

Group Type EXPERIMENTAL

Torasemide

Intervention Type 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

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Marcin Grabowski

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status NOT_YET_RECRUITING

1st Department of Cariology of Medcial University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Marcin Grabowski, PhD

Role: CONTACT

+48 660 751 816

Paweł Balsam, PhD

Role: CONTACT

+48 605152120

Facility Contacts

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Andrzej Folga, PhD

Role: primary

+48 509 935 844

Marcin Grabowski, PhD

Role: primary

+48 660 751 816

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.

Reference Type DERIVED
PMID: 28114980 (View on PubMed)

Other Identifiers

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TORNADO KB/202/2013

Identifier Type: -

Identifier Source: org_study_id

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