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Patients hospitalized for acute decompensation of CHF are usually complicated by worsening renal function (WRF) which leads to diuretic resistance and inadequate decongestion as well as poor prognosis. WRF has been attributed to a reflex renal vasoconstriction elicited by intravascular volume depletion during brisk diuresis. The investigators hypothesize that CHF patients with hepatic dysfunction are more prone to WRF due to poor albumin production. This sub-group of CHF patients may benefit more (increased diuretic efficacy and protected against worsening renal function) by the use of IV loop diuretics in combination with an intravascular volume expander such as IV Human Albumin.
Acute decompensation of chronic heart failure (CHF) warranting hospital admission, defined as diagnosed on the basis of the presence of at least one symptom (dyspnea, orthopnea, paroxysmal nocturnal dyspnea, weight gain, worsening functional class or edema) and one sign (rales, peripheral edema, ascites, increased jugular vein pressure, hepatomegaly, third heart sound gallop or pulmonary vascular congestion on chest radiography) of heart failure plus laboratory or imaging evidence of hepatic dysfunction at randomization
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Human Albumin + IV Furosemide | Active Comparator | Continuous slow IV infusion of Human Albumin plus IV Furosemide |
|
| IV Furosemide alone | Placebo Comparator | Continuous slow IV infusion of Furosemide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human albumin | Drug | Experimental intervention (Group A): Continuous slow IV infusion of Human Albumin, based on diuresis-adjusted dosing, not later than 30 minutes after randomisation and not later than 2 hours after admission. Concomitant continuous slow IV infusion of diuretics (furosemide) based on body weight- and diuresis-adjusted dosing. Control intervention (Group B): Continuous slow IV infusion of diuretics (furosemide), based on body weight - and diuresis-adjusted dosing. Experimental intervention (Human Albumin) is off-label treatment for patients with acute decompensation of CHF in Greece. Control intervention (IV diuretic therapy) is on-label treatment for acute decompensation CHF in Greece. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of symptoms | Patient's global assessment of symptoms, measured with the use of a visual-analogue scale (VAS) and quantified as the area under the curve (AUC) of serial assessments. | From baseline to 72 hours. |
| Change in the serum creatinine level | Change in the serum creatinine level | From baseline to 72 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported dyspnea | Patient-reported dyspnea (as assessed with the use of a VAS and quantified as the AUC of serial assessments) | From baseline to 72 hours. |
| Changes in body weight | Changes in body weight |
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Inclusion Criteria:
There is no pre-specified inclusion criterion with respect to ejection fraction
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MARIOS-VASILEIOS A KOUTROULOS | Contact | +30 6942862493 | mvkoutroulos@gmail.com | |
| ANARGYROS TSALGKIDIS | Contact | 6940926983 | anargyrost@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| MARIOS VASILEIOS KOUTROULOS | University Hospital of Alexandroupolis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DUThrace Cardiology Department | Recruiting | Alexandroupoli | Evros | 68100 | Greece |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| From baseline to 72 hours. |
| Length of stay | Length of stay | From baseline to discharge. |
| The composite of death, rehospitalization, escalation in treatment or an emergency room visit within 180 days. | The composite of death, rehospitalization, escalation in treatment or an emergency room visit within 180 days. | From baseline to 180 days from discharge. |
| Net fluid loss | Net fluid loss | From baseline to 72 hours |
| D001798 |
| Blood Proteins |