Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF Study)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00577135
First received: December 18, 2007
Last updated: April 17, 2013
Last verified: April 2013
Results First Received: January 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Heart Failure
Interventions: Drug: Furosemide-Q12 hour bolus
Drug: Furosemide-Continuous Infusion
Drug: Furosemide-Low Intensification
Drug: Furosemide-High Intensification

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Q12 Hours Bolus & Low Intensification Low intensification (1 x oral dose) IV furosemide by Q12 hours bolus
Q12 Hours Bolus & High Intensification High intensification (2.5 x oral dose) IV furosemide by Q12 hours bolus
Continuous Infusion & Low Intensification Low intensification (1 x oral dose) IV furosemide by continuous infusion
Continuous Infusion & High Intensification High intensification (2.5 x oral dose) IV furosemide by continuous infusion

Participant Flow:   Overall Study
    Q12 Hours Bolus & Low Intensification     Q12 Hours Bolus & High Intensification     Continuous Infusion & Low Intensification     Continuous Infusion & High Intensification  
STARTED     74     82     77     75  
COMPLETED     74     82     77     75  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Q12 Hours Bolus & Low Intensification No text entered.
Q12 Hours Bolus & High Intensification No text entered.
Continuous Infusion & Low Intensification No text entered.
Continuous Infusion & High Intensification No text entered.
Total Total of all reporting groups

Baseline Measures
    Q12 Hours Bolus & Low Intensification     Q12 Hours Bolus & High Intensification     Continuous Infusion & Low Intensification     Continuous Infusion & High Intensification     Total  
Number of Participants  
[units: participants]
  74     82     77     75     308  
Age  
[units: years]
Mean ± Standard Deviation
  67.4  ± 12.4     65.2  ± 13.8     64.5  ± 14.1     67.2  ± 14.0     66.0  ± 13.6  
Gender  
[units: participants]
         
Female     18     23     23     18     82  
Male     56     59     54     57     226  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Patient Well Being, as Determined by a Visual Analog Scale   [ Time Frame: Measured at 72 hours ]

2.  Primary:   Change in Serum Creatinine   [ Time Frame: Measured at baseline and 72 hours ]

3.  Secondary:   Change in Weight   [ Time Frame: baseline and 96 hours ]

4.  Secondary:   Proportion of Patients Free of Congestion   [ Time Frame: Measured at 72 hours ]

5.  Secondary:   Dyspnea, as Determined by Visual Analog Scales   [ Time Frame: Measured at 24 hours ]

6.  Secondary:   Change in Serum Creatinine   [ Time Frame: baseline and 24 hours ]

7.  Secondary:   Change in Cystatin C   [ Time Frame: baseline and 72 hours ]

8.  Secondary:   Change in Serum Creatinine   [ Time Frame: baseline and 48 hours ]

9.  Secondary:   Change in Serum Creatinine   [ Time Frame: baseline and 96 hours ]

10.  Secondary:   Change in Serum Creatinine   [ Time Frame: baseline and day 7 ]

11.  Secondary:   Change in Serum Creatinine   [ Time Frame: baseline and day 60 ]

12.  Secondary:   Patient Well Being, as Determined by a Visual Analog Scale   [ Time Frame: Measured at 24 hours ]

13.  Secondary:   Patient Well Being, as Determined by a Visual Analog Scale   [ Time Frame: 48 hours ]

14.  Secondary:   Dyspnea VAS   [ Time Frame: 48 hours ]

15.  Secondary:   Dyspnea VAS   [ Time Frame: 72 hours ]

16.  Secondary:   Change in Cystatin C   [ Time Frame: baseline and day 7 ]

17.  Secondary:   Change in Cystatin C   [ Time Frame: baseline and day 60 ]

18.  Secondary:   Change in Uric Acid   [ Time Frame: baseline and 72 hours ]

19.  Secondary:   Change in Uric Acid   [ Time Frame: baseline and day 7 ]

20.  Secondary:   Change in Uric Acid   [ Time Frame: baseline and Day 60 ]

21.  Secondary:   Change in B-type Natriuretic Peptide   [ Time Frame: baseline and 72 hours ]

22.  Secondary:   Change in NTproBNP   [ Time Frame: baseline and Day 7 ]

23.  Secondary:   Change in NTproBNP   [ Time Frame: baseline and Day 60 ]

24.  Secondary:   Presence of Cardiorenal Syndrome   [ Time Frame: Within 72 hours ]

25.  Secondary:   Treatment Failure   [ Time Frame: Within 72 hours ]

26.  Secondary:   Net Fluid Loss   [ Time Frame: Through 24 hours ]

27.  Secondary:   Net Fluid Loss   [ Time Frame: Through 48 hours ]

28.  Secondary:   Net Fluid Loss   [ Time Frame: Through 72 hours ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Jeff Sharp
Organization: Duke University
phone: 919.668.7086
e-mail: jeff.sharp@dm.duke.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00577135     History of Changes
Other Study ID Numbers: Pro00017634, U01HL084904-01, U01 HL084904-01, 523
Study First Received: December 18, 2007
Results First Received: January 23, 2013
Last Updated: April 17, 2013
Health Authority: United States: Federal Government