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

NCT01942109 | Unknown Phase 4

• 1 other identifier: TORNADO KB/202/2013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Keywords

heart failure; diuretics; furosemide; torasemide

Outcome Measures

Primary Outcomes (1)

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

  up to 12 months

Secondary Outcomes (2)

• 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

Other Outcomes (4)

• 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

• The change between baseline and final levels of serum biomarkers

  up to 12 months

Study Arms (2)

Furosemide

ACTIVE COMPARATOR

This group will receive furosemide as a diuretic treatment

Drug: Furosemide

Torasemide

EXPERIMENTAL

This group will receive torasemide as a diuretic treatment

Drug: Torasemide

Interventions

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

Furosemide

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

Torasemide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (2)

3rd Clinic of Internal Medicine and Cardiology of Medcial University of Warsaw

Warsaw, Masovian Voivodeship, 00-382, Poland

NOT YET RECRUITING

1st Department of Cariology of Medcial University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 28114980 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Furosemide; Torsemide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marcin Grabowski, PhD

  1st Department of Cardiology Medical University of Warsaw

  STUDY CHAIR

Central Study Contacts

Marcin Grabowski, PhD

CONTACT

+48 660 751 816; marcin.grabowski@wum.edu.pl

Paweł Balsam, PhD

CONTACT

+48 605152120; pawel.balsam@me.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 24, 2013
• First Posted: September 13, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

PL (2)