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

Phase 4

• Conditions: Heart Failure
• Interventions: Drug: Furosemide; Drug: Torasemide

• Registration Number: NCT01942109
• Lead Sponsor: Medical University of Warsaw

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).

Study Timeline

• Study First Submitted: 2013-08-24
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-13
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Furosemide	Furosemide	This group will receive furosemide as a diuretic treatment
Torasemide	Torasemide	This group will receive torasemide as a diuretic treatment

Primary Outcome Measures

Name	Time	Method
The influence of therapy on cardiovascular events associated with heart failure (deaths, hospitalisations)	up to 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

3rd Clinic of Internal Medicine and Cardiology of Medcial University of Warsaw; 🇵🇱 Warsaw, Mazowieckie, Poland

1st Department of Cariology of Medcial University of Warsaw; 🇵🇱 Warsaw, Mazowieckie, Poland