Heart FailurePhase 2/3NCT05652322
Prolonged Intravenous Therapy Versus Early Initiation of an Oral Loop Diuretic in Decompensated Heart Failure
A Phase 2/3 study testing Furosemide Pill 150% equivalent iv dose, Furosemide Pill 200% equivalent iv dose and Furosemide Injection in people with Heart Failure, run by Jan Kochanowski University at 3 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Furosemide Pill 150% equivalent iv dose, Furosemide Pill 200% equivalent iv dose and Furosemide Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesPoland
- Study dates
- 7 Dec 2022to 1 Mar 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Poland3 sites
Wojewodzki Szpital Zespolony Klinika Nefrologii
Kielce
Wojewódzki Szpital Zespolony OIOK
Kielce
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologii
Lodz
About this study
Official title: A Randomized Trial Comparing Prolonged Intravenous Therapy Versus Early Initiation of an Oral Loop Diuretic in Patients Hospitalized for Decompensated Chronic Heart Failure
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
- Being tested
- Furosemide Pill 150% equivalent iv dose, Furosemide Pill 200% equivalent iv dose, Furosemide Injection
- Keywords
- diuretic, oral, intravenous
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide Pill 150% equivalent iv doseDrug
change from intravenous to oral furosemide
Furosemide Pill 200% equivalent iv doseDrug
change from intravenous to oral furosemide
Furosemide InjectionDrug
change from intravenous to oral furosemide
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | prolonged intravenous loop diuretic treatment - furosemide Receives: Drug: Furosemide Injection |
| Group 2 | Experimental | Early (48 hrs) change to oral loop diuretic - furosemide - 150% eqivalent iv dose Receives: Drug: Furosemide Pill 150% equivalent iv dose |
| Group 3 | Experimental | Early (48 hrs) change to oral loop diuretic - furosemide - 200% eqivalent iv dose Receives: Drug: Furosemide Pill 200% equivalent iv dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients requiring hospitalization
any hospitalization due to cardiovascular reasons
Measured: 12 weeks
Time to hospitalization measured in days
Time to any hospitalization due to cardiovascular reasons
Measured: Up to 12 weeks
Secondary outcomes (3)
Death
Cardiovascular death
Measured: 12 weeks
New York Heart Association NYHA class
NYHA class assessment
Measured: 6 and12 weeks
assessment of quality of life
QoL by Minnesota questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start7 Dec 2022
- Primary completion1 Dec 2023
- Study completion1 Mar 2024
Why it stopped: no recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Kochanowski University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zbigniew Siudak, Jan Kochanowski University
- Investigators
- Janusz Sielski, MD, PhD, Principal investigator, Jan Kochanowski Univeristy in Kielce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652322
- Sponsor's protocol ID
- 1/KCW/2022
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2022
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Prolonged Intravenous Therapy Versus Early Initiation of an Oral Loop Diuretic in Patients Hospitalized for Decompensated Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05652322
- Acronym / sponsor ID
- 1/KCW/2022
- Conditions
- Heart Failure
- Keywords
- diuretic, oral, intravenous
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jan Kochanowski UniversityUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Furosemide Injectionprolonged intravenous loop diuretic treatment - furosemide |
| Group 2 | Experimental | Drug: Furosemide Pill 150% equivalent iv doseEarly (48 hrs) change to oral loop diuretic - furosemide - 150% eqivalent iv dose |
| Group 3 | Experimental | Drug: Furosemide Pill 200% equivalent iv doseEarly (48 hrs) change to oral loop diuretic - furosemide - 200% eqivalent iv dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- ✔ NTpro-BNP >450 pg/mL for <55 years, 900 pg/mL for 55-75 years, and >1800 pg/mL for >75 years
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide Pill 150% equivalent iv dosechange from intravenous to oral furosemide | Drug | Group 2 |
| Furosemide Pill 200% equivalent iv dosechange from intravenous to oral furosemide | Drug | Group 3 |
| Furosemide Injectionchange from intravenous to oral furosemide | Drug | Group 1 |
Primary outcome
number of patients requiring hospitalization
Time frame: 12 weeks
any hospitalization due to cardiovascular reasons
Time to hospitalization measured in days
Time frame: Up to 12 weeks
Time to any hospitalization due to cardiovascular reasons
3 secondary outcomes
Death
Time frame: 12 weeks
New York Heart Association NYHA class
Time frame: 6 and12 weeks
assessment of quality of life
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Jan Kochanowski University Kielce, PolandLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janusz Sielski, MD, PhD principal investigator
Jan Kochanowski Univeristy in Kielce
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Furosemide Pill 150% equivalent iv dose, Furosemide Pill 200% equivalent iv dose and Furosemide Injection in people with Heart Failure, run by Jan Kochanowski University at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients requiring hospitalization (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.