Acute Decompensated Heart FailurePhase 4DAD-HF IINCT01060293
Dopamine in Acute Decompensated Heart Failure II
A Phase 4 study testing High-dose furosemide, Low-dose furosemide and Low-dose furosemide combined with low-dose dopamine in people with Acute Decompensated Heart Failure, run by Larissa University Hospital at 6 sites in 2 countries.
Trial summary
The aim of this study is to compare the effects of 1) high-dose furosemide, 2) low-dose furosemide, and 3) low-dose furosemide combined with low-dose dopamine on diuresis, clinical status, renal function, electrolyte balance, length of stay, and 60-day post-discharge outcomes in patients hospitalized with acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- High-dose furosemide, Low-dose furosemide and Low-dose furosemide combined with low-dose dopamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jul 2009to Dec 2013
- 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
- patients with New York Heart Association (NYHA) functional class IV heart failure according to the American Heart Association (AHA) classification, namely dyspnea on minimal exertion or rest dyspnea, orthopnea, and paroxysmal nocturnal dyspnea,
- signs of congestion (third heart sound or pulmonary rales on physical examination),
- pulmonary congestion on chest x-ray,
- serum B-type natriuretic peptide levels > 400 pg/ml or NT-proBNP > 1500 pg/ml,
- echocardiographic documentation of systolic or diastolic dysfunction,
- age >18 years old,
Show all 9Show fewer
- on medical therapy with an ACE-inhibitor and/or a β-blocker,
- experiencing an acute decompensation of known chronic HF,
- baseline oxygen saturation <90% on admission arterial blood gas
Who cannot join
- acute de novo HF;
- severe renal failure (serum creatinine >200 μmol/L or GFR <30 ml/min/1.73m2)
- admission systolic blood pressure <90 mm Hg;
- severe valvular disease;
- known adverse reactions to furosemide or dopamine;
- HF secondary to congenital heart disease;
- a scheduled procedure with a need for IV contrast dye;
- a scheduled cardiac surgery within 6 months
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Greece4 sites
First Department of Cardiology, University of Athens
Athens, Attica
Department of Cardiology, Larissa University Hospital
Larissa, Larissa, 411 10
AHEPA University Hospital
Thessaloniki, Thessaloniki
Department of Cardiology, Volos General Hospital
Volos, Magnesia, 382 21
United States2 sites
Division of Cardiology, Emory University Hospital
Atlanta, Georgia
The Cleveland Clinic Foundation
Cleveland, Ohio
About this study
Official title: Comparison of High-dose Furosemide, Low-dose Furosemide, and the Combination of Low-dose Furosemide and Low-dose Dopamine in Patients With Acute Decompensated Heart Failure
The aim of this study is to compare the effects of 1) high-dose furosemide, 2) low-dose furosemide, and 3) low-dose furosemide combined with low-dose dopamine on diuresis, clinical status, renal function, electrolyte balance, length of stay, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.
Read the detailed description
The aim of this study is to compare the effects of:
- high-dose furosemide (HDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 20 mg/h for a total of 8 hours),
- low-dose furosemide (LDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide for a total of 8 hours), and
- low-dose furosemide combined with low-dose dopamine (LDFD, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide plus 5μg/kg/min dopamine for a total of 8 hours) on diuresis, perceived dyspnea, renal function, electrolyte balance, total length of stay, and 60-day post-discharge outcomes in patients hospitalized with ADHF.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- High-dose furosemide, Low-dose furosemide, Low-dose furosemide combined with low-dose dopamine
- Keywords
- Heart Failure, Dopamine, Furosemide, Worsening Renal Function, Hypokalemia, Outcomes, Prognosis
- Medical subject headings
- Heart Failure, Hypokalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose furosemideDrug
High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
Low-dose furosemideDrug
Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide
Low-dose furosemide combined with low-dose dopamineDrug
Low-dose furosemide combined with low-dose dopamine (LDFD): continuous IV administration of 5 mg/h furosemide combined with 5 μg/kg/min dopamine for a total of 8 hours
| Study group | Role | What they receive |
|---|---|---|
| High-dose furosemide | Active comparator | High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours Receives: Drug: High-dose furosemide |
| Low-dose furosemide | Active comparator | Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide Receives: Drug: Low-dose furosemide |
| Low-dose furosemide combined with low-dose dopamine | Active comparator | Low-dose furosemide combined with low-dose dopamine (LDFD): continuous IV administration of 5 mg/h furosemide combined with 5 μg/kg/min dopamine for a total of 8 hours Receives: Drug: Low-dose furosemide combined with low-dose dopamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Measured: 1-year
Secondary outcomes (2)
60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Measured: 60-day post discharge
Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL)
Measured: Throughout hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJul 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: Safety issues in the LDFD-group (higher heart rate with dopamine)
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 Acute Decompensated 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Giamouzis, Larissa University Hospital
- Investigators
- Gregory Giamouzis, MD, Study chair, Department of Cardiology, Larissa University Hospital, Larissa, GreeceFilippos Triposkiadis, MD, Study chair, Department of Cardiology, Larissa University Hospital, Larissa, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060293
- Sponsor's protocol ID
- 3975
- Acronym
- DAD-HF II
- Status last verified
- Sep 2013
- First submitted
- 1 Feb 2010
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Triposkiadis FK, Butler J, Karayannis G, Starling RC, Filippatos G, Wolski K, Parissis J, Parisis C, Rovithis D, Koutrakis K, Skoularigis J, Antoniou CK, Chrysohoou C, Pitsavos C, Stefanadis C, Nastas J, Tsaknakis T, Mantziari L, Giannakoulas G, Karvounis H, Kalogeropoulos AP, Giamouzis G. Efficacy and safety of high dose versus low dose furosemide with or without dopamine infusion: the Dopamine in Acute Decompensated Heart Failure II (DAD-HF II) trial. Int J Cardiol. 2014 Mar 1;172(1):115-21. doi: 10.1016/j.ijcard.2013.12.276. Epub 2014 Jan 10.
PubMed 24485633
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High-dose Furosemide, Low-dose Furosemide, and the Combination of Low-dose Furosemide and Low-dose Dopamine in Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT01060293
- Acronym / sponsor ID
- DAD-HF II / 3975
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Heart Failure, Dopamine, Furosemide, Worsening Renal Function, Hypokalemia, Outcomes, Prognosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety issues in the LDFD-group (higher heart rate with dopamine)
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 2 Feb 2010 (estimated)
- 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.
The aim of this study is to compare the effects of 1) high-dose furosemide, 2) low-dose furosemide, and 3) low-dose furosemide combined with low-dose dopamine on diuresis, clinical status, renal function, electrolyte balance, length of stay, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.
Detailed description
The aim of this study is to compare the effects of:
- high-dose furosemide (HDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 20 mg/h for a total of 8 hours),
- low-dose furosemide (LDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide for a total of 8 hours), and
- low-dose furosemide combined with low-dose dopamine (LDFD, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide plus 5μg/kg/min dopamine for a total of 8 hours) on diuresis, perceived dyspnea, renal function, electrolyte balance, total length of stay, and 60-day post-discharge outcomes in patients hospitalized with ADHF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose furosemide | Active comparator | Drug: High-dose furosemideHigh-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours |
| Low-dose furosemide | Active comparator | Drug: Low-dose furosemideLow-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide |
| Low-dose furosemide combined with low-dose dopamine | Active comparator | Drug: Low-dose furosemide combined with low-dose dopamineLow-dose furosemide combined with low-dose dopamine (LDFD): continuous IV administration of 5 mg/h furosemide combined with 5 μg/kg/min dopamine for a total of 8 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- patients with New York Heart Association (NYHA) functional class IV heart failure according to the American Heart Association (AHA) classification, namely dyspnea on minimal exertion or rest dyspnea, orthopnea, and paroxysmal nocturnal dyspnea,
- signs of congestion (third heart sound or pulmonary rales on physical examination),
- pulmonary congestion on chest x-ray,
- serum B-type natriuretic peptide levels > 400 pg/ml or NT-proBNP > 1500 pg/ml,
- echocardiographic documentation of systolic or diastolic dysfunction,
Key exclusion criteria (8 listed)
- acute de novo HF;
- severe renal failure (serum creatinine >200 μmol/L or GFR <30 ml/min/1.73m2)
- admission systolic blood pressure <90 mm Hg;
- severe valvular disease;
- known adverse reactions to furosemide or dopamine;
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 |
|---|---|---|
| High-dose furosemideHigh-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours | Drug | High-dose furosemide |
| Low-dose furosemideLow-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide | Drug | Low-dose furosemide |
| Low-dose furosemide combined with low-dose dopamineLow-dose furosemide combined with low-dose dopamine (LDFD): continuous IV administration of 5 mg/h furosemide combined with 5 μg/kg/min dopamine for a total of 8 hours | Drug | Low-dose furosemide combined with low-dose dopamine |
Primary outcome
1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Time frame: 1-year
2 secondary outcomes
60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Time frame: 60-day post discharge
Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL)
Time frame: Throughout hospitalization
Results and safety
The study was stopped early (reason given: Safety issues in the LDFD-group (higher heart rate with dopamine)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
- Derived from this study: PubMed 24485633Triposkiadis FK, Butler J, Karayannis G, Starling RC, Filippatos G, Wolski K, Parissis J, Parisis C, Rovithis D, Koutrakis K, Skoularigis J, Antoniou CK, Chrysohoou C, Pitsavos C, Stefanadis C, Nastas J, Tsaknakis T, Mantziari L, Giannakoulas G, Karvounis H, Kalogeropoulos AP, Giamouzis G. Efficacy and safety of high dose versus low dose furosemide with or without dopamine infusion: the Dopamine in Acute Decompensated Heart Failure II (DAD-HF II) trial. Int J Cardiol. 2014 Mar 1;172(1):115-21. doi: 10.1016/j.ijcard.2013.12.276. Epub 2014 Jan 10.
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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.
Gregory Giamouzis, MD study chair
Department of Cardiology, Larissa University Hospital, Larissa, Greece
Filippos Triposkiadis, MD study chair
Department of Cardiology, Larissa University Hospital, Larissa, Greece
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High-dose furosemide, Low-dose furosemide and Low-dose furosemide combined with low-dose dopamine in people with Acute Decompensated Heart Failure, run by Larissa University Hospital at 6 sites in 2 countries.
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 9 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: stopped early, as of the sponsor's last update on 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Greece, United States. 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 was stopped early (reason given: Safety issues in the LDFD-group (higher heart rate with dopamine)). Results are not available in the source record.
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?
1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure). (time frame: 1-year). 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 NCT01060293, 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 11 Sep 2013.