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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | prolonged intravenous loop diuretic treatment - furosemide |
|
| Group 2 | Experimental | Early (48 hrs) change to oral loop diuretic - furosemide - 150% eqivalent iv dose |
|
| Group 3 | Experimental | Early (48 hrs) change to oral loop diuretic - furosemide - 200% eqivalent iv dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide Pill 150% equivalent iv dose | Drug | change from intravenous to oral furosemide |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Cardiovascular death | 12 weeks |
| New York Heart Association NYHA class | NYHA class assessment | 6 and12 weeks |
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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:
Fluid Retention Features:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janusz Sielski, MD, PhD | Jan Kochanowski Univeristy in Kielce | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wojewodzki Szpital Zespolony Klinika Nefrologii | Kielce | Poland | ||||
| Wojewódzki Szpital Zespolony OIOK |
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| Label | URL |
|---|---|
| Jan Kochanowski University Kielce, Poland | View source |
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| Furosemide Pill 200% equivalent iv dose |
| Drug |
change from intravenous to oral furosemide |
|
| Furosemide Injection | Drug | change from intravenous to oral furosemide |
|
| assessment of quality of life | QoL by Minnesota questionnaire | 12 weeks |
| Kielce |
| Poland |
| Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologii | Lodz | Poland |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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