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

Phase 2

Withdrawn

• Conditions: Heart Failure
• Interventions: Drug: Furosemide Injection; Drug: Furosemide Pill 200% equivalent iv dose; Drug: Furosemide Pill 150% equivalent iv dose

• Registration Number: NCT05652322
• Lead Sponsor: Jan Kochanowski University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-07
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-15
• Primary Completion: 2023-12-01
• Study Completion: 2024-03-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Furosemide Injection	prolonged intravenous loop diuretic treatment - furosemide
Group 3	Furosemide Pill 200% equivalent iv dose	Early (48 hrs) change to oral loop diuretic - furosemide - 200% eqivalent iv dose
Group 2	Furosemide Pill 150% equivalent iv dose	Early (48 hrs) change to oral loop diuretic - furosemide - 150% eqivalent iv dose

Primary Outcome Measures

Name	Time	Method
number of patients requiring hospitalization	12 weeks	any hospitalization due to cardiovascular reasons
Time to hospitalization measured in days	Up to 12 weeks	Time to any hospitalization due to cardiovascular reasons

Secondary Outcome Measures

Name	Time	Method
New York Heart Association NYHA class	6 and12 weeks	NYHA class assessment
assessment of quality of life	12 weeks	QoL by Minnesota questionnaire
Death	12 weeks	Cardiovascular death

Trial Locations

Locations (3)

Wojewodzki Szpital Zespolony Klinika Nefrologii; 🇵🇱 Kielce, Poland

Wojewódzki Szpital Zespolony OIOK; 🇵🇱 Kielce, Poland

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologii; 🇵🇱 Łódź, Poland