Study Stopped
Safety issues in the LDFD-group (higher heart rate with dopamine)
Dopamine in Acute Decompensated Heart Failure II
DAD-HF II
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
1 other identifier
interventional
161
2 countries
6
Brief 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 decompensated heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2009
Longer than P75 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 11, 2013
September 1, 2013
4.4 years
February 1, 2010
September 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
1-year
Secondary Outcomes (2)
60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
60-day post discharge
Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL)
Throughout hospitalization
Study Arms (3)
High-dose furosemide
ACTIVE COMPARATORHigh-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
Low-dose furosemide
ACTIVE COMPARATORLow-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide
Low-dose furosemide combined with low-dose dopamine
ACTIVE COMPARATORLow-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
Interventions
High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide
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
Eligibility Criteria
You may qualify if:
- 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,
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Division of Cardiology, Emory University Hospital
Atlanta, Georgia, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
First Department of Cardiology, University of Athens
Athens, Attica, Greece
Department of Cardiology, Larissa University Hospital
Larissa, Larissa, 411 10, Greece
Department of Cardiology, Volos General Hospital
Volos, Magnesia, 382 21, Greece
AHEPA University Hospital
Thessaloniki, Thessaloniki, Greece
Related Publications (1)
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.
PMID: 24485633DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gregory Giamouzis, MD
Department of Cardiology, Larissa University Hospital, Larissa, Greece
- STUDY CHAIR
Filippos Triposkiadis, MD
Department of Cardiology, Larissa University Hospital, Larissa, Greece
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Cardiology
Study Record Dates
First Submitted
February 1, 2010
First Posted
February 2, 2010
Study Start
July 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
September 11, 2013
Record last verified: 2013-09