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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Furosemide
Torasemide
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, diuretics, furosemide, torasemide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 3rd Clinic of Internal Medicine and Cardiology of Medcial University of Warsaw
  • 1st Department of Cariology of Medcial University of WarsawRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Furosemide

Torasemide

Arm Description

This group will receive furosemide as a diuretic treatment

This group will receive torasemide as a diuretic treatment

Outcomes

Primary Outcome Measures

The influence of therapy on cardiovascular events associated with heart failure (deaths, hospitalisations)

Secondary Outcome Measures

The change of dosing of diuretic due to worsening of condition of patient.
The change of NYHA (New York Heart Association) class - worsening or improvement

Full Information

First Posted
August 24, 2013
Last Updated
June 7, 2017
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT01942109
Brief Title
The Impact of TORasemide oN hemodynAmic and Neurohormonal Stress, and carDiac remOdeling in Heart Failure
Acronym
TORNADO
Official Title
The Impact of TORasemide oN hemodynAmic and Neurohormonal Stress, and carDiac remOdeling in Heart Failure - Prospective, Randomized, Open, Blinded Endpoint Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, diuretics, furosemide, torasemide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Furosemide
Arm Type
Active Comparator
Arm Description
This group will receive furosemide as a diuretic treatment
Arm Title
Torasemide
Arm Type
Experimental
Arm Description
This group will receive torasemide as a diuretic treatment
Intervention Type
Drug
Intervention Name(s)
Furosemide
Intervention Description
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
Intervention Name(s)
Torasemide
Intervention Description
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
Primary Outcome Measure Information:
Title
The influence of therapy on cardiovascular events associated with heart failure (deaths, hospitalisations)
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
The change of dosing of diuretic due to worsening of condition of patient.
Time Frame
up to 12 months
Title
The change of NYHA (New York Heart Association) class - worsening or improvement
Time Frame
up to 12 months
Other Pre-specified Outcome Measures:
Title
The measurement of fluid retention with ZOE Fluid Status Monitor
Time Frame
up to 12 months
Title
≥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
Title
The change between baseline and final levels of serum biomarkers
Time Frame
up to 12 months
Title
The assessment of quality of life
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcin Grabowski, PhD
Phone
+48 660 751 816
Email
marcin.grabowski@wum.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Paweł Balsam, PhD
Phone
+48 605152120
Email
pawel.balsam@me.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Grabowski, PhD
Organizational Affiliation
1st Department of Cardiology Medical University of Warsaw
Official's Role
Study Chair
Facility Information:
Facility Name
3rd Clinic of Internal Medicine and Cardiology of Medcial University of Warsaw
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-382
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrzej Folga, PhD
Phone
+48 509 935 844
Email
and.folga@gmail.com
First Name & Middle Initial & Last Name & Degree
Andrzej Folga, PhD
First Name & Middle Initial & Last Name & Degree
Artur Mamcarz, Professor
First Name & Middle Initial & Last Name & Degree
Marcin Wełnicki
First Name & Middle Initial & Last Name & Degree
Daniel Śliż, PhD
Facility Name
1st Department of Cariology of Medcial University of Warsaw
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcin Grabowski, PhD
Phone
+48 660 751 816
Email
marcin.grabowski@wum.edu.pl
First Name & Middle Initial & Last Name & Degree
Marcin Grabowski, PhD
First Name & Middle Initial & Last Name & Degree
Grzegorz Opolski, Professor
First Name & Middle Initial & Last Name & Degree
Paweł Balsam, PhD
First Name & Middle Initial & Last Name & Degree
Renata Główczyńska, PhD
First Name & Middle Initial & Last Name & Degree
Eliza Kozyra-Pydys, MD
First Name & Middle Initial & Last Name & Degree
Krzysztof J Filipiak, Professor
First Name & Middle Initial & Last Name & Degree
Michał Peller, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
28114980
Citation
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.
Results Reference
derived

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

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