Chronic Heart FailurePhase 4DEA-HFNCT05904808
The Heart Failure Diuresis Efficacy Comparison (DEA-HF) Study
A Phase 4 study testing IV Furosemide, IV Furosemide and PO Metolazone and IV Furosemide and IV Acetazolamide in people with Chronic Heart Failure and Diuretics Drug Reactions, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
To investigate the effectiveness of three (3) IV diuretic regimens to increase natriuresis in volume-overloaded HF patients, allowing for better decongestion and potentially resulting in improved clinical and biochemical parameters outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Diuretics Drug Reactions, Congestive Heart Failure
- What is being tested?
- IV Furosemide, IV Furosemide and PO Metolazone and IV Furosemide and IV Acetazolamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Apr 2023to 24 Aug 2023
- Phase
- Phase 4
- 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
- Signed written informed consent must be obtained before any study assessment is performed.
- Male or female patients 18 years of age or older
- Confirmed Diagnosis of Heart Failure (per ESC guidelines 20212)
- At least one sign of active congestion at recruitment: Jugular venous pressure(JVP)/Ascites/Edema/Pulmonary rales/Pleural effusion/ Lung ultrasound B lines >3 lines (at 6 sites).
- Patient is at least on two heart failure drugs including: BB, MRA, sGLT2i, ACEI/ARB/ARNI (or has a clinical reason for its absence) and on oral diuretics for the last 30 days before study inclusion.
Who cannot join
- History of myocardial infraction in the last 14 days prior to patient randomization.
- History of a cardiac transplantation and/or ventricular assist device.
- Mean blood pressure <60 mmHg at screening
- Simultaneous use of intravenous inotropes, vasopressors or nitroprusside due to acute decompensated heart failure in the last 14 days.
- Estimated glomerular filtration rate <20ml/min/1.73m2 at screening
- Any circumstances where urine collection is not possible.
- Use of renal replacement therapy or ultrafiltration 30 days prior to patient randomization.
- Subjects who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diuresis Efficacy in Ambulatory Chronic Heart Failure Patients With Volume Overload- Intra -Patient Comparison of Three Diuretics Regimens
To investigate the effectiveness of three (3) IV diuretic regimens to increase natriuresis in volume-overloaded HF patients, allowing for better decongestion and potentially resulting in improved clinical and biochemical parameters outcome.
Read the detailed description
The study will assess the efficacy and safety of three (3) different clinically prevailing diuretic regimens. All three regimens are based on furosemide, as mentioned above- a 1st line HF GL2,3 recommended and MOH registered 7 for fluid decongestion, and the two adjuvants medications are also approved as diuretics in HF patients. Better natriuresis will lead to better decongestion in CHF patients with volume overload. It is expected that the better natriuresis will lead to better decongestion, and improvement in favorable markers parameters such as NT pro BNP.
The trial will investigate treatment regimens, readily available, clinically approved ("on-label" in Israel), which can be very easily administered, through an IV infusion or IV and PO administration without additional extra testing or invasive monitoring. The setting is in an established dedicated HF day-care unit at the cardiology department of Rambam Health Campus (RMC)- a tertiary referral academic center.
The knowledge gathered in this study, could be easily adopted by every clinic or hospital in a quick manner with considerable cost-savings with regards to health care expenditure.
Importantly, this study will examine which application of existing decongestive therapies (not novel drugs), based on strong scientific reasoning, will result in a better outcome for patients. Therefore, data from the study will provide information regarding the safety and efficacy of diuretic treatment in the above-mentioned patient population.
The study intends to be a real-life study, in the manner of:
- Conducted in an established, protocol-operated setting
- Essential only recruitment restrictions
- Without any additional testing to the day care standard of care
- Have minimal or no additional expected risk for the patient (comparison between standard diuretic regimens)
- Have very clinically meaningful endpoints.
Therefore, this study should be considered a 'Low-intervention clinical trial' as:
- The investigational medicinal products, which are used in clinical practice and approved, have a very low-risk profile and are well-known to general cardiologists and internists worldwide.
- According to the protocol of the clinical trial, all investigational medicinal products will be used in accordance with EU and US marketing approval according to published guidelines. Note: from commercial and supply chain reasons oral metolazone and IV acetazolamide are imported by medical institutions in Israel by means of group "29 gimel" form. Both are FDA and EU labeled for HF treatment.
- No additional diagnostic or monitoring procedures are asked. Hence, minimal additional risk or burden to the safety of the subjects compared to normal clinical practice.
- Being tested
- IV Furosemide, IV Furosemide and PO Metolazone, IV Furosemide and IV Acetazolamide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV FurosemideDrug
Given over 4-hour drip using IV pump, 40mg of the 250mg will be given as a bolus
IV Furosemide and PO MetolazoneDrug
Given over 4-hour drip using IV pump, 40mg of the 250mg will be given as a bolus +5mg PO Metolazone
IV Furosemide and IV AcetazolamideDrug
Also called Oral Magnesium citrate 600mg
Furosemide would be given over 4-hour drip using IV pump, 40mg of the 250mg will be given as a bolus.
500mg IV Acetazolamide would be given in 100cc of saline over half an hour
| Study group | Role | What they receive |
|---|---|---|
| Diuretic comparison | Active comparator | each participant will be followed for 4 consecutive weeks. during which 3 different diuretic regimens will be given (random sequence). Last week follow up without protocol regimen. Receives: Drug: IV Furosemide; Drug: IV Furosemide and PO Metolazone; Drug: IV Furosemide and IV Acetazolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium weight
Na Weight (Spot Na * total volume of urine)
Measured: 1st week visit (time zero)
Sodium weight
Na Weight (Spot Na * total volume of urine)
Measured: 1 week after 1st visit
Sodium weight
Na Weight (Spot Na * total volume of urine)
Measured: 2 weeks after 1st visit
Secondary outcomes (18)
Urine Volume
Total urinary volume starting from initiation of intravenous (IV) therapy for 6 hours
Measured: 1st week visit (time zero)
Urine Volume
Total urinary volume starting from initiation of intravenous (IV) therapy for 6 hours
Measured: 1 week after 1st visit
Urine Volume
Total urinary volume starting from initiation of intravenous (IV) therapy for 6 hours
Measured: 2 weeks after 1st visit
Rate of symptomatic hypotension events
Systolic BP <90mmhg with symptoms
Measured: A week after 1st visit
Rate of symptomatic hypotension events
Systolic BP <90mmhg with symptoms
Measured: 2 weeks after 1st visit
Rate of symptomatic hypotension events
Systolic BP <90mmhg with symptoms
Measured: 3 weeks after 1st visit
rate of worsening renal function events
WRF defined as a >0.3 mg/dL increase in serum Cr, or a >20% decrease in eGFR by the CKDEPI formula
Measured: A week after 1st visit
rate of worsening renal function events
WRF defined as a >0.3 mg/dL increase in serum Cr, or a >20% decrease in eGFR by the CKDEPI formula
Measured: 2 weeks After 1st visit
rate of worsening renal function events
WRF defined as a >0.3 mg/dL increase in serum Cr, or a >20% decrease in eGFR by the CKDEPI formula
Measured: 3 weeks after 1st visit
Rate of hyponatremia during treatment phase
Hyponatremia <133mmol/dl
Measured: A week after 1st visit
Rate of hyponatremia during treatment phase
Hyponatremia <133mmol/dl
Measured: 2 weeks after 1st visit
Rate of hyponatremia during treatment phase
Hyponatremia <133mmol/dl
Measured: 3 weeks after 1st visit
Rate of dyskalemia events during treatment phase
Dyskalemia defined as <3.5 or >5.6mmol/dl
Measured: A week after 1st visit
Rate of dyskalemia events during treatment phase
Dyskalemia defined as <3.5 or >5.6mmol/dl
Measured: 2 weeks after 1st visit
Rate of dyskalemia events during treatment phase
Dyskalemia defined as <3.5 or >5.6mmol/dl
Measured: 3 weeks after 1st visit
Rate of metabolic acidosis events requiring NaHCO3 supplements
Rate of Metabolic acidosis (requiring NaHCO3 supplements) events
Measured: A week after 1st visit
Rate of metabolic acidosis events requiring NaHCO3 supplements
Rate of Metabolic acidosis (requiring NaHCO3 supplements) events
Measured: 2 weeks after 1st visit
Rate of metabolic acidosis events requiring NaHCO3 supplements
Rate of Metabolic acidosis (requiring NaHCO3 supplements) events
Measured: 3 weeks after 1st visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start19 Apr 2023
- Primary completion1 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-site, single-arm, open-label, cross-over controlled study Randomization will determine the sequence of the three (3) regimens
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aharon (Ronnie) Abbo MD, Rambam Health Care Campus
- Investigators
- Aharon Abbo, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904808
- Sponsor's protocol ID
- 0067-23-RMB
- Acronym
- DEA-HF
- Status last verified
- May 2024
- First submitted
- 22 May 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diuresis Efficacy in Ambulatory Chronic Heart Failure Patients With Volume Overload- Intra -Patient Comparison of Three Diuretics Regimens
- ClinicalTrials.gov ID
- NCT05904808
- Acronym / sponsor ID
- DEA-HF / 0067-23-RMB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 15 Jun 2023 (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.
To investigate the effectiveness of three (3) IV diuretic regimens to increase natriuresis in volume-overloaded HF patients, allowing for better decongestion and potentially resulting in improved clinical and biochemical parameters outcome.
Detailed description
The study will assess the efficacy and safety of three (3) different clinically prevailing diuretic regimens. All three regimens are based on furosemide, as mentioned above- a 1st line HF GL2,3 recommended and MOH registered 7 for fluid decongestion, and the two adjuvants medications are also approved as diuretics in HF patients. Better natriuresis will lead to better decongestion in CHF patients with volume overload. It is expected that the better natriuresis will lead to better decongestion, and improvement in favorable markers parameters such as NT pro BNP.
The trial will investigate treatment regimens, readily available, clinically approved ("on-label" in Israel), which can be very easily administered, through an IV infusion or IV and PO administration without additional extra testing or invasive monitoring. The setting is in an established dedicated HF day-care unit at the cardiology department of Rambam Health Campus (RMC)- a tertiary referral academic center.
The knowledge gathered in this study, could be easily adopted by every clinic or hospital in a quick manner with considerable cost-savings with regards to health care expenditure.
Importantly, this study will examine which application of existing decongestive therapies (not novel drugs), based on strong scientific reasoning, will result in a better outcome for patients. Therefore, data from the study will provide information regarding the safety and efficacy of diuretic treatment in the above-mentioned patient population.
The study intends to be a real-life study, in the manner of:
- Conducted in an established, protocol-operated setting
- Essential only recruitment restrictions
- Without any additional testing to the day care standard of care
- Have minimal or no additional expected risk for the patient (comparison between standard diuretic regimens)
- Have very clinically meaningful endpoints.
Therefore, this study should be considered a 'Low-intervention clinical trial' as:
- The investigational medicinal products, which are used in clinical practice and approved, have a very low-risk profile and are well-known to general cardiologists and internists worldwide.
- According to the protocol of the clinical trial, all investigational medicinal products will be used in accordance with EU and US marketing approval according to published guidelines. Note: from commercial and supply chain reasons oral metolazone and IV acetazolamide are imported by medical institutions in Israel by means of group "29 gimel" form. Both are FDA and EU labeled for HF treatment.
- No additional diagnostic or monitoring procedures are asked. Hence, minimal additional risk or burden to the safety of the subjects compared to normal clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-site, single-arm, open-label, cross-over controlled study Randomization will determine the sequence of the three (3) regimens
| Arm | Type | Receives |
|---|---|---|
| Diuretic comparison | Active comparator | Drug: IV Furosemide, Drug: IV Furosemide and PO Metolazone, Drug: IV Furosemide and IV Acetazolamideeach participant will be followed for 4 consecutive weeks. during which 3 different diuretic regimens will be given (random sequence). Last week follow up without protocol regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed written informed consent must be obtained before any study assessment is performed.
- Male or female patients 18 years of age or older
- Confirmed Diagnosis of Heart Failure (per ESC guidelines 20212)
- At least one sign of active congestion at recruitment: Jugular venous pressure(JVP)/Ascites/Edema/Pulmonary rales/Pleural effusion/ Lung ultrasound B lines >3 lines (at 6 sites).
- Patient is at least on two heart failure drugs including: BB, MRA, sGLT2i, ACEI/ARB/ARNI (or has a clinical reason for its absence) and on oral diuretics for the last 30 days before study inclusion.
Key exclusion criteria (8 listed)
- History of myocardial infraction in the last 14 days prior to patient randomization.
- History of a cardiac transplantation and/or ventricular assist device.
- Mean blood pressure <60 mmHg at screening
- Simultaneous use of intravenous inotropes, vasopressors or nitroprusside due to acute decompensated heart failure in the last 14 days.
- Estimated glomerular filtration rate <20ml/min/1.73m2 at screening
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 |
|---|---|---|
| IV FurosemideGiven over 4-hour drip using IV pump, 40mg of the 250mg will be given as a bolus | Drug | Diuretic comparison |
| IV Furosemide and PO MetolazoneGiven over 4-hour drip using IV pump, 40mg of the 250mg will be given as a bolus +5mg PO Metolazone | Drug | Diuretic comparison |
| IV Furosemide and IV AcetazolamideAlso: Oral Magnesium citrate 600mgFurosemide would be given over 4-hour drip using IV pump, 40mg of the 250mg will be given as a bolus. 500mg IV Acetazolamide would be given in 100cc of saline over half an hour | Drug | Diuretic comparison |
Primary outcome
Sodium weight
Time frame: 1st week visit (time zero)
Na Weight (Spot Na * total volume of urine)
Sodium weight
Time frame: 1 week after 1st visit
Na Weight (Spot Na * total volume of urine)
Sodium weight
Time frame: 2 weeks after 1st visit
Na Weight (Spot Na * total volume of urine)
18 secondary outcomes
Urine Volume
Time frame: 1st week visit (time zero)
Urine Volume
Time frame: 1 week after 1st visit
Urine Volume
Time frame: 2 weeks after 1st visit
Rate of symptomatic hypotension events
Time frame: A week after 1st visit
Rate of symptomatic hypotension events
Time frame: 2 weeks after 1st visit
Rate of symptomatic hypotension events
Time frame: 3 weeks after 1st visit
rate of worsening renal function events
Time frame: A week after 1st visit
rate of worsening renal function events
Time frame: 2 weeks After 1st visit
rate of worsening renal function events
Time frame: 3 weeks after 1st visit
Rate of hyponatremia during treatment phase
Time frame: A week after 1st visit
Rate of hyponatremia during treatment phase
Time frame: 2 weeks after 1st visit
Rate of hyponatremia during treatment phase
Time frame: 3 weeks after 1st visit
Rate of dyskalemia events during treatment phase
Time frame: A week after 1st visit
Rate of dyskalemia events during treatment phase
Time frame: 2 weeks after 1st visit
Rate of dyskalemia events during treatment phase
Time frame: 3 weeks after 1st visit
Rate of metabolic acidosis events requiring NaHCO3 supplements
Time frame: A week after 1st visit
Rate of metabolic acidosis events requiring NaHCO3 supplements
Time frame: 2 weeks after 1st visit
Rate of metabolic acidosis events requiring NaHCO3 supplements
Time frame: 3 weeks after 1st visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 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. This study is not recruiting at the moment.
Aharon Abbo, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV Furosemide, IV Furosemide and PO Metolazone and IV Furosemide and IV Acetazolamide in people with Chronic Heart Failure and Diuretics Drug Reactions, run by Rambam Health Care Campus at 1 site in Israel.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 21 May 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 Israel. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sodium weight (time frame: 1st week visit (time zero)). The study lists 3 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 21 May 2024.