Diuretics Drug ReactionsPhase 3NCT06630923
PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS
A Phase 3 study testing Human albumin in people with Diuretics Drug Reactions and Heart Failure; With Decompensation, run by Democritus University of Thrace at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Diuretics Drug Reactions, Heart Failure; With Decompensation, Albumin; Double
- What is being tested?
- Human albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteGreece
- Study dates
- 14 Jan 2023to 11 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 yrs
- acute decompensation of CHF
- evidence of hepatic dysfunction by laboratory biochemical measurements or imaging (liver ultrasonography)
- history of CHF with previous use of an oral loop diuretic
- anticipated need for IV diuretic therapy for at least 72 hours
- There is no pre-specified inclusion criterion with respect to ejection fraction
Who cannot join
- 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).
- hepatic dysfunction of other than cardiac etiology
- severe anemia (Hb<8 g/dL)
- uncontrolled hypertension or hypertensive emergency/urgency
- pulmonary edema or pulmonary congestion necessitating use of IV vasodilators
- serum creatinine > 3 mg/dL or glomerular filtration rate (GFR) < 30 ml/min
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
DUThrace Cardiology Department
Alexandroupoli, Evros, 68100
Marios Vasileios Β Koutroulos, 6942862493, mvkoutroulos@gmail.com
About this study
Official title: HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL
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.
Read the detailed description
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
- Being tested
- Human albumin
- Keywords
- Human Albumin, Furosemide, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human albuminDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| IV Human Albumin + IV Furosemide | Active comparator | Continuous slow IV infusion of Human Albumin plus IV Furosemide Receives: Drug: Human albumin |
| IV Furosemide alone | Placebo comparator | Continuous slow IV infusion of Furosemide Receives: Drug: Human albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 72 hours.
Change in the serum creatinine level
Change in the serum creatinine level
Measured: From baseline to 72 hours.
Secondary outcomes (5)
Patient-reported dyspnea
Patient-reported dyspnea (as assessed with the use of a VAS and quantified as the AUC of serial assessments)
Measured: From baseline to 72 hours.
Changes in body weight
Changes in body weight
Measured: From baseline to 72 hours.
Length of stay
Length of stay
Measured: 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.
Measured: From baseline to 180 days from discharge.
Net fluid loss
Net fluid loss
Measured: From baseline to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start14 Jan 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diuretics Drug ReactionsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marios-Vasileios Koutroulos, Democritus University of Thrace
- Investigators
- MARIOS VASILEIOS KOUTROULOS, Principal investigator, University Hospital of Alexandroupolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630923
- Sponsor's protocol ID
- 6/ 29.2.2016
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL
- ClinicalTrials.gov ID
- NCT06630923
- Acronym / sponsor ID
- 6/ 29.2.2016
- Keywords
- Human Albumin, Furosemide, Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 14 Jan 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 8 Oct 2024 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Human Albumin + IV Furosemide | Active comparator | Drug: Human albuminContinuous slow IV infusion of Human Albumin plus IV Furosemide |
| IV Furosemide alone | Placebo comparator | Drug: Human albuminContinuous slow IV infusion of Furosemide |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age over 18 yrs
- acute decompensation of CHF
- evidence of hepatic dysfunction by laboratory biochemical measurements or imaging (liver ultrasonography)
- history of CHF with previous use of an oral loop diuretic
- anticipated need for IV diuretic therapy for at least 72 hours
Key exclusion criteria (6 listed)
- 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).
- hepatic dysfunction of other than cardiac etiology
- severe anemia (Hb<8 g/dL)
- uncontrolled hypertension or hypertensive emergency/urgency
- pulmonary edema or pulmonary congestion necessitating use of IV vasodilators
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 |
|---|---|---|
| Human albuminExperimental 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. | Drug | IV Furosemide alone, IV Human Albumin + IV Furosemide |
Primary outcome
Assessment of symptoms
Time frame: From baseline to 72 hours.
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.
Change in the serum creatinine level
Time frame: From baseline to 72 hours.
Change in the serum creatinine level
5 secondary outcomes
Patient-reported dyspnea
Time frame: From baseline to 72 hours.
Changes in body weight
Time frame: From baseline to 72 hours.
Length of stay
Time frame: From baseline to discharge.
The composite of death, rehospitalization, escalation in treatment or an emergency room visit within 180 days.
Time frame: From baseline to 180 days from discharge.
Net fluid loss
Time frame: From baseline to 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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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.
MARIOS VASILEIOS KOUTROULOS principal investigator
University Hospital of Alexandroupolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Human albumin in people with Diuretics Drug Reactions and Heart Failure; With Decompensation, run by Democritus University of Thrace at 1 site in Greece.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MARIOS-VASILEIOS A KOUTROULOS (+30 6942862493, mvkoutroulos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of symptoms (time frame: From baseline to 72 hours.). 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 8 Oct 2024.