Heart Failure NYHA Class IIIPhase 3DRAINNCT03592836
Diuretic Response in Advanced Heart Failure: Bolus Intermittent vs Continuous INfusion
A Phase 3 study testing Loop Diuretics in people with Heart Failure NYHA Class III and Heart Failure NYHA Class IV, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Loop diuretics are the main therapy for decongestion of patients with advanced acute heart failure. However, these patients often develop diuretic-resistance or even diuretic-refractoriness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- What is being tested?
- Loop Diuretics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2013to 22 Dec 2017
- Phase
- Phase 3
- 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
- Advanced heart failure
- WET ≥ 12
- Systolic blood pressure ≤ 110 mmHg
- Serum sodium ≤ 135 mEq/L
- Left systolic ventricular insufficiency (FE < 35%) note for at least 6 months
- Class NYHA III-IV despite medical treatment maximal
Who cannot join
- Acute coronary syndrome
- Shock cardiogenic
- Chronic renal failure stage V
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diuretic Treatment in High Risk Decompensated Advanced Heart Failure. Bolus Intermittent Versus Continuous Infusion of Furosemide: a Randomized Controlled Trial.
Loop diuretics are the main therapy for decongestion of patients with advanced acute heart failure. However, these patients often develop diuretic-resistance or even diuretic-refractoriness. In order to overcome such resistance to diuretic, the clinician can increase the dose of furosemide, or change the way of administration (continuous infusion versus boluses) or associate a different class of diuretics (thiazide diuretics, K+-sparing diuretics) up to the addition of low doses of inotropic agents to improve renal perfusion. At the present time there is no evidence in literature in advanced acute heart failure patients about the superiority of the treatment with furosemide in continuous infusion or in intermittent boluses. The aim of the study was to evaluate the efficacy of furosemide in boluses versus continuous infusion in advanced acute heart failure.
- Being tested
- Loop Diuretics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loop DiureticsDrug
Also called furosemide
intravenous administration of diuretics
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion of loop diuretics | Active comparator | Furosemide continuous infusion: 125 or 250 mg die Receives: Drug: Loop Diuretics |
| Intermittent infusion of loop diuretics | Active comparator | Furosemide bolus intermittent: 125 or 250 mg die Receives: Drug: Loop Diuretics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from congestion
Measured: 72 hours after randomization
Secondary outcomes (6)
Worsening of renal function
Increase in creatinine value > 0.3 mg/dl or increase > 1.5 times
Measured: 72 hours after randomization
Worsening or persistent HF at 72 h
Need to increase the dose of inotropes or diuretics
Measured: 72 hours after randomization
Change in body weight
Measured: 72 hours after randomization
Laboratory data variations in NTproBNP
Measured: 72 hours after randomization
Treatment failure
Composed by the following events: persistence of congestion, need to increase diuretic treatment, need of renal replacement treatment
Measured: 72 hours after randomization
Weight differences based on diuretic dose unity
Measured: 72 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 May 2013
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure NYHA Class IIIStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Frea, University of Turin, Italy
- Investigators
- Simone Frea, MD, Principal investigator, A.O.U. Città della Salute e della Scienza di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592836
- Sponsor's protocol ID
- DRAIN trial
- Acronym
- DRAIN
- Status last verified
- Jul 2018
- First submitted
- 18 Jun 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Frea S, Pidello S, Volpe A, Canavosio FG, Galluzzo A, Bovolo V, Camarda A, Golzio PG, D'Ascenzo F, Bergerone S, Rinaldi M, Gaita F. Diuretic treatment in high-risk acute decompensation of advanced chronic heart failure-bolus intermittent vs. continuous infusion of furosemide: a randomized controlled trial. Clin Res Cardiol. 2020 Apr;109(4):417-425. doi: 10.1007/s00392-019-01521-y. Epub 2019 Jun 29.
PubMed 31256261
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diuretic Treatment in High Risk Decompensated Advanced Heart Failure. Bolus Intermittent Versus Continuous Infusion of Furosemide: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03592836
- Acronym / sponsor ID
- DRAIN / DRAIN trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 19 Jul 2018 (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.
Loop diuretics are the main therapy for decongestion of patients with advanced acute heart failure. However, these patients often develop diuretic-resistance or even diuretic-refractoriness. In order to overcome such resistance to diuretic, the clinician can increase the dose of furosemide, or change the way of administration (continuous infusion versus boluses) or associate a different class of diuretics (thiazide diuretics, K+-sparing diuretics) up to the addition of low doses of inotropic agents to improve renal perfusion. At the present time there is no evidence in literature in advanced acute heart failure patients about the superiority of the treatment with furosemide in continuous infusion or in intermittent boluses. The aim of the study was to evaluate the efficacy of furosemide in boluses versus continuous infusion in advanced acute heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion of loop diuretics | Active comparator | Drug: Loop DiureticsFurosemide continuous infusion: 125 or 250 mg die |
| Intermittent infusion of loop diuretics | Active comparator | Drug: Loop DiureticsFurosemide bolus intermittent: 125 or 250 mg die |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Advanced heart failure
- WET ≥ 12
- Systolic blood pressure ≤ 110 mmHg
- Serum sodium ≤ 135 mEq/L
- Left systolic ventricular insufficiency (FE < 35%) note for at least 6 months
Key exclusion criteria (3 listed)
- Acute coronary syndrome
- Shock cardiogenic
- Chronic renal failure stage V
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 |
|---|---|---|
| Loop DiureticsAlso: furosemideintravenous administration of diuretics | Drug | Continuous infusion of loop diuretics, Intermittent infusion of loop diuretics |
Primary outcome
Freedom from congestion
Time frame: 72 hours after randomization
6 secondary outcomes
Worsening of renal function
Time frame: 72 hours after randomization
Worsening or persistent HF at 72 h
Time frame: 72 hours after randomization
Change in body weight
Time frame: 72 hours after randomization
Laboratory data variations in NTproBNP
Time frame: 72 hours after randomization
Treatment failure
Time frame: 72 hours after randomization
Weight differences based on diuretic dose unity
Time frame: 72 hours after randomization
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 19 Jul 2018.
- Derived from this study: PubMed 31256261Frea S, Pidello S, Volpe A, Canavosio FG, Galluzzo A, Bovolo V, Camarda A, Golzio PG, D'Ascenzo F, Bergerone S, Rinaldi M, Gaita F. Diuretic treatment in high-risk acute decompensation of advanced chronic heart failure-bolus intermittent vs. continuous infusion of furosemide: a randomized controlled trial. Clin Res Cardiol. 2020 Apr;109(4):417-425. doi: 10.1007/s00392-019-01521-y. Epub 2019 Jun 29.
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Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
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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.
Simone Frea, MD principal investigator
A.O.U. Città della Salute e della Scienza di Torino
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 Loop Diuretics in people with Heart Failure NYHA Class III and Heart Failure NYHA Class IV, run by University of Turin, Italy at 1 site in Italy.
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 3 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 19 Jul 2018. 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 Italy. 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 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?
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?
Freedom from congestion (time frame: 72 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03592836, which also lists 1 linked publication.
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 19 Jul 2018.