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

Jan Kochanowski University

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Heart Failure

Treatments: Drug: Furosemide Pill 150% equivalent iv dose; Drug: Furosemide Pill 200% equivalent iv dose; Drug: Furosemide Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05652322

1/KCW/2022

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  1. 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)

  2. 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

  3. Exacerbation of heart failure treated with at least 40 mg of furosemide IV. (or 20 mg torasemide equivalent)

  4. Left ventricular ejection fraction < 50% (assessed and documented in the last 12 months prior to study entry)

  5. Age >= 18 years

  6. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Group 1

Active Comparator group

Description:

prolonged intravenous loop diuretic treatment - furosemide

Treatment:

Drug: Furosemide Injection

Group 2

Experimental group

Description:

Early (48 hrs) change to oral loop diuretic - furosemide - 150% eqivalent iv dose

Treatment:

Drug: Furosemide Pill 150% equivalent iv dose

Group 3

Experimental group

Description:

Early (48 hrs) change to oral loop diuretic - furosemide - 200% eqivalent iv dose

Treatment:

Drug: Furosemide Pill 200% equivalent iv dose