Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial | NCT00937092

Studies
Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial

NCT00937092

Sponsor

Larissa University Hospital

Status

Unknown status

Last Update Posted

May 26, 2010Estimated

Enrollment

300Estimated

Phase

Phase 4

Conditions

Acute Heart Failure

Interventions

Furosemide
low-dose dopamine + low-dose furosemide

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2010Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Jun 29, 2009

First Submission Date that Met QC Criteria

Jul 9, 2009

First Posted Date

Jul 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2010

Last Update Posted Date

May 26, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-dose furosemide	Active Comparator	High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours	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	Drug: low-dose dopamine + low-dose furosemide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Furosemide	Drug	High-dose furosemide(HDF, furosemide 20 mg/h intravenously)	High-dose furosemide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).		1-year

Secondary Outcomes

Measure	Description	Time Frame
60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).		60 days post discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 β-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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Filippos Triposkiadis, MD	Contact	+30 2410682821		ftriposkiadis@yahoo.com
Gregory Giamouzis, MD	Contact	+30 6937212670		ggiamou@emory.edu

Overall Officials

Name	Affiliation	Role
Gregory Giamouzis, MD	Larissa University Hospital	Principal Investigator
Filippos Triposkiadis, MD	Larissa University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, Larissa University Hospital	Recruiting	Larissa	Larissa	411 10	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21111980	Derived	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.

ID	Term
D006333	Heart Failure
D007008	Hypokalemia

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases

ID	Term
D013424	Sulfanilamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals