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Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction (ROPA-DOP)

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ClinicalTrials.gov Identifier: NCT01901809
Recruitment Status : Completed
First Posted : July 17, 2013
Results First Posted : May 17, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Heart Failure, Diastolic
Interventions Drug: Furosemide
Drug: Dopamine
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bolus Furosemide Continuous Infusion Furosemide Bolus Furosemide Plus Dopamine Continuous Furosemide Plus Dopamine
Hide Arm/Group Description

If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.

If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).

Furosemide

If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.

If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).

Furosemide

Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.

Furosemide

Dopamine

Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.

Furosemide

Dopamine

Period Title: Overall Study
Started 19 23 24 24
Completed 19 23 21 22
Not Completed 0 0 3 2
Arm/Group Title Bolus Furosemide Continuous Infusion Furosemide Bolus Furosemide Plus Dopamine Continuous Furosemide Plus Dopamine Total
Hide Arm/Group Description

If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.

If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).

Furosemide

If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.

If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).

Furosemide

Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.

Furosemide

Dopamine

Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.

Furosemide

Dopamine

Total of all reporting groups
Overall Number of Baseline Participants 19 23 24 24 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 23 participants 24 participants 24 participants 90 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  47.4%
10
  43.5%
12
  50.0%
11
  45.8%
42
  46.7%
>=65 years
10
  52.6%
13
  56.5%
12
  50.0%
13
  54.2%
48
  53.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 23 participants 24 participants 24 participants 90 participants
68  (13) 63  (10) 66  (15) 67  (13) 66  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 23 participants 24 participants 24 participants 90 participants
Female
17
  89.5%
12
  52.2%
17
  70.8%
15
  62.5%
61
  67.8%
Male
2
  10.5%
11
  47.8%
7
  29.2%
9
  37.5%
29
  32.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 23 participants 24 participants 24 participants 90 participants
Black 12 14 15 15 56
White 6 9 9 9 33
Other 1 0 0 0 1
1.Primary Outcome
Title Percent Change in Serum Creatinine at 72 Hours.
Hide Description Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bolus Furosemide and no Dopamine Continuous Infusion Furosemide and no Dopamine Bolus Furosemide Plus Dopamine Continuous Furosemide Plus Dopamine
Hide Arm/Group Description:

If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.

If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).

Furosemide

If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.

If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).

Furosemide

Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min

Furosemide

Dopamine

Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min

Furosemide

Dopamine

Overall Number of Participants Analyzed 19 23 24 24
Mean (Standard Deviation)
Unit of Measure: percent change in serum creatinine
4  (22) 11  (21) 5  (17) 20  (28)
2.Primary Outcome
Title Percent Change in Serum Creatinine at 72 Hours - Continuous vs Intermittent Diuretic
Hide Description Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by diuretic strategy
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bolus Furosemide Continuous Infusion Furosemide
Hide Arm/Group Description:

If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.

If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).

If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.

If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).

Overall Number of Participants Analyzed 43 47
Mean (95% Confidence Interval)
Unit of Measure: percent change in serum creatinine
4.6
(-1.1 to 10.4)
16
(8.5 to 23.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bolus Furosemide, Continuous Infusion Furosemide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 11.4
Confidence Interval (2-Sided) 95%
2.0 to 20.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.7
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percent Change in Serum Creatinine at 72 Hours - Dopamine vs No Dopamine
Hide Description Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by dopamine strategy
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dopamine No Dopamine
Hide Arm/Group Description:
Diuretic therapy plus addition of dopamine at 3 µg/kg/min administered as an infusion.
Diuretic therapy only
Overall Number of Participants Analyzed 48 42
Mean (95% Confidence Interval)
Unit of Measure: percent change in serum creatinine
8.0
(1.4 to 14.6)
12.8
(5.7 to 20.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dopamine, No Dopamine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.8
Confidence Interval (2-Sided) 95%
-14.4 to 4.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.8
Estimation Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bolus Furosemide Continuous Infusion Furosemide Bolus Furosemide Plus Dopamine Continuous Furosemide Plus Dopamine
Hide Arm/Group Description

If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.

If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).

Furosemide

If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.

If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).

Furosemide

Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.

Furosemide

Dopamine

Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion.

Furosemide

Dopamine

All-Cause Mortality
Bolus Furosemide Continuous Infusion Furosemide Bolus Furosemide Plus Dopamine Continuous Furosemide Plus Dopamine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/19 (26.32%)   3/22 (13.64%)   4/23 (17.39%)   3/22 (13.64%) 
Hide Serious Adverse Events
Bolus Furosemide Continuous Infusion Furosemide Bolus Furosemide Plus Dopamine Continuous Furosemide Plus Dopamine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/22 (0.00%)   0/23 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bolus Furosemide Continuous Infusion Furosemide Bolus Furosemide Plus Dopamine Continuous Furosemide Plus Dopamine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/22 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Early termination leading to small numbers of subjects analyzed. The investigator team was blinded to study assignment; however, the patient and treating physicians were un-blinded.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kavita Sharma, MD
Organization: Johns Hopkins University School of Medicine
Phone: 410-955-7670
EMail: ksharma8@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01901809    
Other Study ID Numbers: NA 00083629
First Submitted: May 15, 2013
First Posted: July 17, 2013
Results First Submitted: April 18, 2018
Results First Posted: May 17, 2018
Last Update Posted: August 16, 2018