Trial Outcomes & Findings for Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction (NCT NCT01901809)

NCT ID: NCT01901809

Last Updated: 2018-08-16

Results Overview

Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 90 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2018-08-16

Participant Flow

Participant milestones

Measure	Bolus Furosemide 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	Continuous Infusion 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	Bolus Furosemide Plus Dopamine Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion. Furosemide Dopamine	Continuous Furosemide Plus Dopamine Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion. Furosemide Dopamine
Overall Study STARTED	19	23	24	24
Overall Study COMPLETED	19	23	21	22
Overall Study NOT COMPLETED	0	0	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction

Baseline characteristics by cohort

Measure	Bolus Furosemide n=19 Participants 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	Continuous Infusion Furosemide n=23 Participants 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	Bolus Furosemide Plus Dopamine n=24 Participants Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion. Furosemide Dopamine	Continuous Furosemide Plus Dopamine n=24 Participants Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min administered as an infusion. Furosemide Dopamine	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	11 Participants n=4 Participants	42 Participants n=21 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	13 Participants n=4 Participants	48 Participants n=21 Participants
Age, Continuous	68 years STANDARD_DEVIATION 13 • n=5 Participants	63 years STANDARD_DEVIATION 10 • n=7 Participants	66 years STANDARD_DEVIATION 15 • n=5 Participants	67 years STANDARD_DEVIATION 13 • n=4 Participants	66 years STANDARD_DEVIATION 13 • n=21 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants	15 Participants n=4 Participants	61 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	29 Participants n=21 Participants
Race/Ethnicity, Customized Black	12 participants n=5 Participants	14 participants n=7 Participants	15 participants n=5 Participants	15 participants n=4 Participants	56 participants n=21 Participants
Race/Ethnicity, Customized White	6 participants n=5 Participants	9 participants n=7 Participants	9 participants n=5 Participants	9 participants n=4 Participants	33 participants n=21 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants

PRIMARY outcome

Timeframe: 72 hours

Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation.

Outcome measures

Measure	Bolus Furosemide and no Dopamine n=19 Participants 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	Continuous Infusion Furosemide and no Dopamine n=23 Participants 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	Bolus Furosemide Plus Dopamine n=24 Participants Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min Furosemide Dopamine	Continuous Furosemide Plus Dopamine n=24 Participants Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min Furosemide Dopamine
Percent Change in Serum Creatinine at 72 Hours.	4 percent change in serum creatinine Standard Deviation 22	11 percent change in serum creatinine Standard Deviation 21	5 percent change in serum creatinine Standard Deviation 17	20 percent change in serum creatinine Standard Deviation 28

PRIMARY outcome

Timeframe: 72 hours

Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by diuretic strategy

Outcome measures

Measure	Bolus Furosemide and no Dopamine n=43 Participants 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	Continuous Infusion Furosemide and no Dopamine n=47 Participants 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	Bolus Furosemide Plus Dopamine Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min Furosemide Dopamine	Continuous Furosemide Plus Dopamine Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min Furosemide Dopamine
Percent Change in Serum Creatinine at 72 Hours - Continuous vs Intermittent Diuretic	4.6 percent change in serum creatinine Interval -1.1 to 10.4	16 percent change in serum creatinine Interval 8.5 to 23.4	—	—

PRIMARY outcome

Timeframe: 72 hours

Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by dopamine strategy

Outcome measures

Measure	Bolus Furosemide and no Dopamine n=48 Participants 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	Continuous Infusion Furosemide and no Dopamine n=42 Participants 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	Bolus Furosemide Plus Dopamine Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min Furosemide Dopamine	Continuous Furosemide Plus Dopamine Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min Furosemide Dopamine
Percent Change in Serum Creatinine at 72 Hours - Dopamine vs No Dopamine	8.0 percent change in serum creatinine Interval 1.4 to 14.6	12.8 percent change in serum creatinine Interval 5.7 to 20.0	—	—

Adverse Events

Bolus Furosemide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Continuous Infusion Furosemide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Bolus Furosemide Plus Dopamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Continuous Furosemide Plus Dopamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kavita Sharma, MD

Johns Hopkins University School of Medicine

Phone: 410-955-7670

Email: ksharma8@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place