Prolonged Intravenous Therapy Versus Early Initiation of an Oral Loop Diuretic in Decompensated Heart Failure

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical study is to compare treatment regimens of loop diuretics in patients with decompensated heart failure. The main aim is to answer if early change from intravenous to oral loop diuretics is safe and effective.

Official Title
-----------------
A Randomized Trial Comparing Prolonged Intravenous Therapy Versus Early Initiation of an Oral Loop Diuretic in Patients Hospitalized for Decompensated Chronic Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: Furosemide Pill 150% equivalent iv dose
* Drug: Furosemide Pill 200% equivalent iv dose
* Drug: Furosemide Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient hospitalized due to exacerbation of heart failure symptoms, where AHF is the main cause of hospitalization. To be included in the study, all criteria 1 to 6 must be met: Fluid Retention Features: Described congestion above the lung fields on chest X-ray rales on chest auscultation Peripheral edema, yielding to pressure occurring within the limbs or the sacral part of the spine Increased pressure in the jugular veins (>=8 cm H2O) The concentration of natiuretic peptides must be assessed within 24 hours of admission to the hospital and be: ✔ NTpro-BNP >450 pg/mL for <55 years, 900 pg/mL for 55-75 years, and >1800 pg/mL for >75 years Exacerbation of heart failure treated with at least 40 mg of furosemide IV. (or 20 mg torasemide equivalent) Left ventricular ejection fraction < 50% (assessed and documented in the last 12 months prior to study entry) Age >= 18 years The study participant gave and signed an informed consent to participate in the study. No medical procedure related to the study was performed prior to giving informed consent. Exclusion Criteria: 1. Shortness of breath caused by respiratory infection, exacerbation of bronchial asthma, COPD 2. Body temperature > 38 C, signs of active infection requiring antibiotic therapy, sepsis, infective endocarditis 3. An episode of acute coronary syndrome, stroke or TIA within 6 months before randomization 4. Severe valvular disease requiring or in the process of qualifying for repair 5. Patients requiring dialysis (in the past, during hospitalization or in the process of qualifying for dialysis) 6. History of alcohol abuse in the last 2 years before randomization 7. Pregnancy or breastfeeding 8. Active cancer or in remission for less than 5 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>prolonged intravenous loop diuretic treatment - furosemide | Drug: Furosemide Injection<br>* change from intravenous to oral furosemide<br>|
| Experimental: Group 2<br>Early (48 hrs) change to oral loop diuretic - furosemide - 150% eqivalent iv dose | Drug: Furosemide Pill 150% equivalent iv dose<br>* change from intravenous to oral furosemide<br>|
| Experimental: Group 3<br>Early (48 hrs) change to oral loop diuretic - furosemide - 200% eqivalent iv dose | Drug: Furosemide Pill 200% equivalent iv dose<br>* change from intravenous to oral furosemide<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients requiring hospitalization | any hospitalization due to cardiovascular reasons | 12 weeks | 
| Time to hospitalization measured in days | Time to any hospitalization due to cardiovascular reasons | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Cardiovascular death | 12 weeks | 
| New York Heart Association NYHA class | NYHA class assessment | 6 and12 weeks | 
| assessment of quality of life | QoL by Minnesota questionnaire | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diuretic, oral, intravenous