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

NCT00937092 | Unknown Phase 4

• 1 other identifier: LUH-DC-101-FT
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Heart Failure

Keywords

Heart Failure; Dopamine; Furosemide; Worsening Renal Function; Hypokalemia; Outcomes; Prognosis

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 (1)

• 60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).

  60 days post discharge

Study Arms (2)

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

Furosemide DRUG

High-dose furosemide(HDF, furosemide 20 mg/h intravenously)

High-dose furosemide

low-dose dopamine + low-dose furosemide DRUG

low-dose furosemide combined with low-dose dopamine (LDFD, furosemide 5 mg/h plus dopamine 5μg/kg/min intravenously)

low-dose dopamine + low-dose furosemide

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Larissa University Hospital: lead

Study Sites (2)

Department of Cardiology, Larissa University Hospital

Larissa, Larissa, 411 10, Greece

RECRUITING

Department of Cardiology, Volos General Hospital

Volos, Magnesia, 382 21, Greece

RECRUITING

Related Publications (1)

• 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.

  PMID: 21111980 DERIVED

MeSH Terms

Conditions

Heart Failure; Hypokalemia

Interventions

Furosemide; Dopamine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Gregory Giamouzis, MD

  Larissa University Hospital

  PRINCIPAL INVESTIGATOR

• Filippos Triposkiadis, MD

  Larissa University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filippos Triposkiadis, MD

CONTACT

+30 2410682821; ftriposkiadis@yahoo.com

Gregory Giamouzis, MD

CONTACT

+30 6937212670; ggiamou@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: July 10, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: July 1, 2012
• Last Updated: May 26, 2010

Record last verified: 2010-05

Locations

GR (2)