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

NCT05652322 | Withdrawn Phase 2 DMC

• 1 other identifier: 1/KCW/2022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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

Keywords

diuretic; oral; intravenous

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Death

  12 weeks

• New York Heart Association NYHA class

  6 and12 weeks

• assessment of quality of life

  12 weeks

Study Arms (3)

Group 1

ACTIVE COMPARATOR

prolonged intravenous loop diuretic treatment - furosemide

Drug: Furosemide Injection

Group 2

EXPERIMENTAL

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

Drug: Furosemide Pill 150% equivalent iv dose

Group 3

EXPERIMENTAL

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

Drug: Furosemide Pill 200% equivalent iv dose

Interventions

Furosemide Pill 150% equivalent iv dose DRUG

change from intravenous to oral furosemide

Group 2

Furosemide Pill 200% equivalent iv dose DRUG

change from intravenous to oral furosemide

Group 3

Furosemide Injection DRUG

change from intravenous to oral furosemide

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Jan Kochanowski University: lead

Study Sites (3)

Wojewodzki Szpital Zespolony Klinika Nefrologii

Kielce, Poland

Location

Wojewódzki Szpital Zespolony OIOK

Kielce, Poland

Location

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

Lodz, Poland

Location

Related Links

• Jan Kochanowski University Kielce, Poland

MeSH Terms

Conditions

Heart Failure

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Janusz Sielski, MD, PhD

  Jan Kochanowski Univeristy in Kielce

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: December 7, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

PL (3)