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

NCT ID: NCT05652322

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-07
• Study Completion Date: 2024-03-01

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

prolonged intravenous loop diuretic treatment - furosemide

Group Type: ACTIVE_COMPARATOR

Furosemide Injection

Intervention Type: DRUG

change from intravenous to oral furosemide

Group 2

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

Group Type: EXPERIMENTAL

Furosemide Pill 150% equivalent iv dose

Intervention Type: DRUG

change from intravenous to oral furosemide

Group 3

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

Group Type: EXPERIMENTAL

Furosemide Pill 200% equivalent iv dose

Intervention Type: DRUG

change from intravenous to oral furosemide

Interventions

Furosemide Pill 150% equivalent iv dose

change from intravenous to oral furosemide

Intervention Type: DRUG

Furosemide Pill 200% equivalent iv dose

change from intravenous to oral furosemide

Intervention Type: DRUG

Furosemide Injection

change from intravenous to oral furosemide

Intervention Type: DRUG

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jan Kochanowski University

OTHER

Sponsor Role: lead

Responsible Party

Zbigniew Siudak

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janusz Sielski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jan Kochanowski Univeristy in Kielce

Locations

Wojewodzki Szpital Zespolony Klinika Nefrologii

Kielce, , Poland

Wojewódzki Szpital Zespolony OIOK

Kielce, , Poland

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologii

Lodz, , Poland

Countries

Poland

Related Links

https://interna.ujk.edu.pl/

Jan Kochanowski University Kielce, Poland

Other Identifiers

1/KCW/2022

Identifier Type: -

Identifier Source: org_study_id