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

June 7, 2017 updated by: Marcin Grabowski, Medical University of Warsaw

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 00-382
        • Not yet recruiting
        • 3rd Clinic of Internal Medicine and Cardiology of Medcial University of Warsaw
        • Contact:
        • Principal Investigator:
          • Andrzej Folga, PhD
        • Sub-Investigator:
          • Artur Mamcarz, Professor
        • Sub-Investigator:
          • Marcin Wełnicki
        • Sub-Investigator:
          • Daniel Śliż, PhD
      • Warsaw, Mazowieckie, Poland, 02-097
        • Recruiting
        • 1st Department of Cariology of Medcial University of Warsaw
        • Contact:
        • Principal Investigator:
          • Marcin Grabowski, PhD
        • Sub-Investigator:
          • Grzegorz Opolski, Professor
        • Sub-Investigator:
          • Paweł Balsam, PhD
        • Sub-Investigator:
          • Renata Główczyńska, PhD
        • Sub-Investigator:
          • Eliza Kozyra-Pydys, MD
        • Sub-Investigator:
          • Krzysztof J Filipiak, Professor
        • Sub-Investigator:
          • Michał Peller, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Furosemide
This group will receive furosemide as a diuretic treatment
Drug: 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
Experimental: Torasemide
This group will receive torasemide as a diuretic treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The influence of therapy on cardiovascular events associated with heart failure (deaths, hospitalisations)
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The change of dosing of diuretic due to worsening of condition of patient.
Time Frame: up to 12 months
up to 12 months
The change of NYHA (New York Heart Association) class - worsening or improvement
Time Frame: up to 12 months
up to 12 months

Other Outcome Measures

Outcome Measure
Time Frame
The measurement of fluid retention with ZOE Fluid Status Monitor
Time Frame: up to 12 months
up to 12 months
≥30% or ≥200 pg/ml increase of NTproBNP (N-terminal pro B type natriuretic peptide) level compared with baseline value
Time Frame: up to 12 months
up to 12 months
The change between baseline and final levels of serum biomarkers
Time Frame: up to 12 months
up to 12 months
The assessment of quality of life
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Chair: Marcin Grabowski, PhD, 1st Department of Cardiology Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

August 24, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TORNADO KB/202/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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