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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00937092 |
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Date of registration:
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29/06/2009 |
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Primary sponsor: |
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Public title:
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Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial
DAD-HF |
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Scientific title:
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Comparison of High-dose Furosemide Versus the Combination of Low-dose Furosemide and Low-dose Dopamine in Patients With Acute Decompensated Heart Failure |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00937092 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Greece
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Contacts
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Name:
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Filippos Triposkiadis, MD |
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Address:
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Telephone:
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+30 2410682821 |
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Email:
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ftriposkiadis@yahoo.com |
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Affiliation:
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Name:
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Filippos Triposkiadis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Larissa University Hospital |
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Name:
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Gregory Giamouzis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Larissa University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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:
- Age >18 years old
- on medical therapy with an ACE-inhibitor and/or a ß-blocker
- experiencing an acute decompensation of known chronic HF
- Having baseline oxygen saturation <90% on admission arterial blood gas
Exclusion Criteria:
- 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
- HF secondary to congenital heart disease
- a scheduled procedure with a need for IV contrast dye
- a scheduled cardiac surgery within 6 months
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Heart Failure
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Intervention(s)
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Drug: Furosemide
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Drug: low-dose dopamine + low-dose furosemide
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Primary Outcome(s)
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1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
[Time Frame: 1-year]
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Secondary Outcome(s)
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60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
[Time Frame: 60 days post discharge]
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Secondary ID(s)
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LUH-DC-101-FT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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