ClinicalTrials.gg
WithdrawnNCT05652322Updated Feb 20, 2025

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

A Phase 2/3 interventional study of Furosemide Pill 150% equivalent iv dose and Furosemide Pill 200% equivalent iv dose in Heart Failure, sponsored by Jan Kochanowski University. Withdrawn at 3 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Jan Kochanowski University · Phase 2/3, Interventional, and Treatment

Why this study was withdrawn
no recruitment
Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • diuretic
  • oral
  • intravenous
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

Browse Heart Failure studies →

Lead sponsor

Jan Kochanowski University is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. \< 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 to participate in the study. No medical procedure related to the study was performed prior to giving informed consent.

Exclusion criteria

Exclusion Criteria:

    1. Shortness of breath caused by respiratory infection, exacerbation of bronchial asthma, 2. Body temperature > 38 C, signs of active infection requiring antibiotic therapy, sepsis, infective endocarditis 3. An episode of acute coronary syndrome, stroke or 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Group 1

    prolonged intravenous loop diuretic treatment - furosemide

    Drug: Furosemide Injection

  • Experimental
    Group 2

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

    Drug: Furosemide Pill 150% equivalent iv dose

  • Experimental
    Group 3

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

    Drug: Furosemide Pill 200% equivalent iv dose

Interventions

  • DrugFurosemide Pill 150% equivalent iv dose

    change from intravenous to oral furosemide

  • DrugFurosemide Pill 200% equivalent iv dose

    change from intravenous to oral furosemide

  • change from intravenous to oral furosemide

06

What researchers measure

Primary outcomes

  1. number of patients requiring hospitalization

    any hospitalization due to cardiovascular reasons

    Time frame: 12 weeks

  2. Time to hospitalization measured in days

    Time to any hospitalization due to cardiovascular reasons

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Death

    Cardiovascular death

    Time frame: 12 weeks

  2. New York Heart Association NYHA class

    NYHA class assessment

    Time frame: 6 and12 weeks

  3. assessment of quality of life

    QoL by Minnesota questionnaire

    Time frame: 12 weeks

07

Study locations

3 sites
  • 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
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05652322
Lead sponsor
Jan Kochanowski University
Responsible party
Zbigniew Siudak (Professor, Jan Kochanowski University) — Principal investigator
First posted
Dec 15, 2022
Start date
Dec 7, 2022
Primary completion
Dec 1, 2023
Completion
Mar 1, 2024
Last update
Feb 20, 2025

Study contacts

Janusz Sielski, MD, PhD
principal investigator · Jan Kochanowski Univeristy in Kielce

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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