NCT06630923 PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS
| NCT ID | NCT06630923 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Democritus University of Thrace |
| Condition | Diuretics Drug Reactions |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-01-14 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 250 participants in total. It began in 2023-01-14 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. age over 18 yrs 2. acute decompensation of CHF 3. evidence of hepatic dysfunction by laboratory biochemical measurements or imaging (liver ultrasonography) 4. history of CHF with previous use of an oral loop diuretic 5. anticipated need for IV diuretic therapy for at least 72 hours There is no pre-specified inclusion criterion with respect to ejection fraction Exclusion Criteria: 1. hemodynamic collapse (at least one of the following: systolic blood pressure (BP) \< 90 mmHg, or BP drop by \>= 40 mmHg for \>= 15 min, with end-organ hypoperfusion; need for inotropes (except of digoxin); need for cardiopulmonary resuscitation). 2. hepatic dysfunction of other than cardiac etiology 3. severe anemia (Hb\<8 g/dL) 4. uncontrolled hypertension or hypertensive emergency/urgency 5. pulmonary edema or pulmonary congestion necessitating use of IV vasodilators 6. serum creatinine \> 3 mg/dL or glomerular filtration rate (GFR) \< 30 ml/min
Contact & Investigator
MARIOS VASILEIOS KOUTROULOS
PRINCIPAL INVESTIGATOR
University Hospital of Alexandroupolis
Frequently Asked Questions
Who can join the NCT06630923 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 95 Years, studying Diuretics Drug Reactions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06630923 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 250 participants.
Is NCT06630923 currently recruiting?
Yes, NCT06630923 is actively recruiting participants. Contact the research team at mvkoutroulos@gmail.com for enrollment information.
Where is the NCT06630923 trial being conducted?
This trial is being conducted at Alexandroupoli, Greece.
Who is sponsoring the NCT06630923 clinical trial?
NCT06630923 is sponsored by Democritus University of Thrace. The principal investigator is MARIOS VASILEIOS KOUTROULOS at University Hospital of Alexandroupolis. The trial plans to enroll 250 participants.