Trial Outcomes & Findings for Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy (NCT NCT00842023)

NCT ID: NCT00842023

Last Updated: 2013-08-30

Results Overview

Serum creatinine values and changes in serum creatinine

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 89 participants
• Primary outcome timeframe: Baseline, 24 hours, 48 hours
• Results posted on: 2013-08-30

Participant Flow

Participant milestones

Measure	Nesiritide Infusion 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.	Nitroglycerin Infusion 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
Overall Study STARTED	45	44
Overall Study COMPLETED	45	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy

Baseline characteristics by cohort

Measure	Nesiritide Infusion n=45 Participants 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.	Nitroglycerin Infusion n=44 Participants 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.	Total n=89 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
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants	20 Participants n=7 Participants	46 Participants n=5 Participants
Age Continuous	68.6 years STANDARD_DEVIATION 14.1 • n=5 Participants	66.8 years STANDARD_DEVIATION 17.2 • n=7 Participants	67.7 years STANDARD_DEVIATION 16.7 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	44 participants n=7 Participants	89 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 24 hours, 48 hours

Serum creatinine values and changes in serum creatinine

Outcome measures

Measure	Nesiritide n=45 Participants 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.	Nitroglycerin n=44 Participants 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment
Renal Function by Serum Creatinine Serum creatinine at 48 hours	1.3 mg/dL Standard Deviation 0.4	1.4 mg/dL Standard Deviation 0.5
Renal Function by Serum Creatinine Serum creatinine at baseline	1.3 mg/dL Standard Deviation 0.4	1.3 mg/dL Standard Deviation 0.4
Renal Function by Serum Creatinine Serum creatinine at 24 hours	1.3 mg/dL Standard Deviation 0.4	1.4 mg/dL Standard Deviation 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 hours

Population: Only participants with available data were assessed for this outcome measure.

Interleukin-6

Outcome measures

Measure	Nesiritide n=36 Participants 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.	Nitroglycerin n=30 Participants 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment
Inflammatory Markers	25 pg/mL Standard Error 7	50 pg/mL Standard Error 5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 24 hours, 48 hours

Population: Only participants with available data were assessed for this outcome measure.

Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function.

Outcome measures

Measure	Nesiritide n=36 Participants 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.	Nitroglycerin n=30 Participants 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment
Serum Levels of Cystatin-C Cystatin-C at Baseline	1332 ng/mL Standard Deviation 1308	2026 ng/mL Standard Deviation 1814
Serum Levels of Cystatin-C Cystatin-C at 24 Hours	1475 ng/mL Standard Deviation 1291	3108 ng/mL Standard Deviation 3761
Serum Levels of Cystatin-C Cystatin-C at 48 Hours	1449 ng/mL Standard Deviation 1298	2739 ng/mL Standard Deviation 3369

Adverse Events

Nesiritide Infusion

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Nitroglycerin Infusion

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nesiritide Infusion n=45 participants at risk 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.	Nitroglycerin Infusion n=44 participants at risk 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
Cardiac disorders Symptomatic Hypotension	11.1% 5/45 • Number of events 5 • 2 years	11.4% 5/44 • Number of events 5 • 2 years
General disorders Death	15.6% 7/45 • Number of events 7 • 2 years	15.9% 7/44 • Number of events 7 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sheryl L. Chow

Western University of Health Sciences

Phone: 9094695379

Email: schow@westernu.edu

Results disclosure agreements

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