Acute Heart FailurePhase 4DAD-HFNCT00937092
Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial
A Phase 4 study testing Furosemide and low-dose dopamine + low-dose furosemide in people with Acute Heart Failure, run by Larissa University Hospital at 2 sites in Greece.
Trial summary
The aim of this study is to compare the effects of high-dose furosemide versus low-dose furosemide combined with low-dose dopamine on diuresis, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Furosemide and low-dose dopamine + low-dose furosemide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesGreece
- Study dates
- Jan 2009to Jul 2012
- 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 to 90 years
- 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
- all candidate patients must be:
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- Age >18 years old
- on medical therapy with an ACE-inhibitor and/or a β-blocker
- experiencing an acute decompensation of known chronic HF
- Having baseline oxygen saturation <90% on admission arterial blood gas
Who cannot join
- the investigators will exclude patients with:
- 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
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- 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
2 sites in 1 country.
Greece2 sites, 2 recruiting
- Recruiting
Department of Cardiology, Larissa University Hospital
Larissa, Larissa, 411 10
Gregory Giamouzis, MD
Filippos Triposkiadis, MD
- Recruiting
Department of Cardiology, Volos General Hospital
Volos, Magnesia, 382 21
Themistoklis Tsaknakis, MD
John Nastas, MD
About this study
Official title: Comparison of High-dose Furosemide Versus 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 high-dose furosemide versus low-dose furosemide combined with low-dose dopamine on diuresis, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.
Read the detailed description
Worsening renal function (WRF) and hypokalemia related to diuretic use for acute decompensated heart failure (ADHF) are common and portend poor prognosis. Low dose dopamine infusion improves renal perfusion. Whether dopamine infusion improves diuresis and/or reduces renal complication in ADHF is not known. 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) vs. 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, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with ADHF.
- Conditions
- Acute Heart Failure
- Being tested
- Furosemide, low-dose dopamine + low-dose furosemide
- 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.
FurosemideDrug
High-dose furosemide(HDF, furosemide 20 mg/h intravenously)
low-dose dopamine + low-dose furosemideDrug
low-dose furosemide combined with low-dose dopamine (LDFD, furosemide 5 mg/h plus dopamine 5μg/kg/min intravenously)
| 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: Furosemide |
| low-dose dopamine + low-dose furosemide | 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 dopamine + low-dose furosemide |
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 (1)
60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Measured: 60 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2010 (estimated)
- Study completionJul 2012 (estimated)
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 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gregory Giamouzis, MD, Principal investigator, Larissa University HospitalFilippos Triposkiadis, MD, Principal investigator, Larissa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937092
- Sponsor's protocol ID
- LUH-DC-101-FT
- Acronym
- DAD-HF
- Status last verified
- May 2010
- First submitted
- 29 Jun 2009
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Giamouzis G, Butler J, Starling RC, Karayannis G, Nastas J, Parisis C, Rovithis D, Economou D, Savvatis K, Kirlidis T, Tsaknakis T, Skoularigis J, Westermann D, Tschope C, Triposkiadis F. Impact of dopamine infusion on renal function in hospitalized heart failure patients: results of the Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial. J Card Fail. 2010 Dec;16(12):922-30. doi: 10.1016/j.cardfail.2010.07.246.
PubMed 21111980
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High-dose Furosemide Versus the Combination of Low-dose Furosemide and Low-dose Dopamine in Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT00937092
- Acronym / sponsor ID
- DAD-HF / LUH-DC-101-FT
- Conditions
- Acute Heart Failure
- Keywords
- Heart Failure, Dopamine, Furosemide, Worsening Renal Function, Hypokalemia, Outcomes, Prognosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 10 Jul 2009 (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 high-dose furosemide versus low-dose furosemide combined with low-dose dopamine on diuresis, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.
Detailed description
Worsening renal function (WRF) and hypokalemia related to diuretic use for acute decompensated heart failure (ADHF) are common and portend poor prognosis. Low dose dopamine infusion improves renal perfusion. Whether dopamine infusion improves diuresis and/or reduces renal complication in ADHF is not known. 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) vs. 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, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with ADHF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose furosemide | Active comparator | Drug: FurosemideHigh-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours |
| low-dose dopamine + low-dose furosemide | Active comparator | Drug: low-dose dopamine + low-dose furosemideLow-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 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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 (9 listed)
- the investigators will exclude patients with:
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 |
|---|---|---|
| FurosemideHigh-dose furosemide(HDF, furosemide 20 mg/h intravenously) | Drug | High-dose furosemide |
| low-dose dopamine + low-dose furosemidelow-dose furosemide combined with low-dose dopamine (LDFD, furosemide 5 mg/h plus dopamine 5μg/kg/min intravenously) | Drug | low-dose dopamine + low-dose furosemide |
Primary outcome
1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Time frame: 1-year
1 secondary outcome
60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Time frame: 60 days post discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
- Derived from this study: PubMed 21111980Giamouzis G, Butler J, Starling RC, Karayannis G, Nastas J, Parisis C, Rovithis D, Economou D, Savvatis K, Kirlidis T, Tsaknakis T, Skoularigis J, Westermann D, Tschope C, Triposkiadis F. Impact of dopamine infusion on renal function in hospitalized heart failure patients: results of the Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial. J Card Fail. 2010 Dec;16(12):922-30. doi: 10.1016/j.cardfail.2010.07.246.
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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 principal investigator
Larissa University Hospital
Filippos Triposkiadis, MD principal investigator
Larissa University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Furosemide and low-dose dopamine + low-dose furosemide in people with Acute Heart Failure, run by Larissa University Hospital at 2 sites 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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filippos Triposkiadis, MD (+30 2410682821, ftriposkiadis@yahoo.com), or a site near the patient. 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 NCT00937092, 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 26 May 2010.