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

Heart Failure Clinical Trial

— TORNADO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01942109
• Other study ID #: TORNADO KB/202/2013
• Status: Recruiting
• Phase: Phase 4
• First received: August 24, 2013
• Last updated: June 7, 2017
• Start date: September 2013
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: Medical University of Warsaw
• Contact: Marcin Grabowski, PhD
• Phone: +48 660 751 816
• Email: marcin.grabowski[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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
• 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

Locations

Country	Name	City	State
Poland	1st Department of Cariology of Medcial University of Warsaw	Warsaw	Mazowieckie
Poland	3rd Clinic of Internal Medicine and Cardiology of Medcial University of Warsaw	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The measurement of fluid retention with ZOE Fluid Status Monitor		up to 12 months
Other	=30% or =200 pg/ml increase of NTproBNP (N-terminal pro B type natriuretic peptide) level compared with baseline value		up to 12 months
Other	The change between baseline and final levels of serum biomarkers		up to 12 months
Other	The assessment of quality of life		up to 12 months
Primary	The influence of therapy on cardiovascular events associated with heart failure (deaths, hospitalisations)		up to 12 months
Secondary	The change of dosing of diuretic due to worsening of condition of patient.		up to 12 months
Secondary	The change of NYHA (New York Heart Association) class - worsening or improvement		up to 12 months