Acute Decompensated Heart Failure
Conditions
Keywords
Natriuretic peptides, BNP, Heart Failure, Nitoglycerin, Biomarkers
Brief summary
The purpose of this study is to determine whether Nesiritide is more effective than nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity when proper infusion duration is administered.
Detailed description
No additional details provided
Interventions
DRUGNesiritide
Bolus 2 mcg/kg followed by 0.01 mcg/kg/min
DRUGNitroglycerin
5-10 mcg/min titrating per protocol based on blood pressure
Sponsors
American College of Clinical Pharmacy
Western University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age. * Subject must be able to understand the potential risks and benefits associated with the study. * Baseline systolic blood pressure ≥ 90 mm Hg at the time of enrollment. * Clinical symptoms of dyspnea and laboratory admission BNP levels \> 500 pg/mL. * Neither pregnant or breastfeeding at the time of enrollment. * Authorization of patient's enrollment by patient's medical provider.
Exclusion criteria
* \<18 years of age * Denies written informed consent * Pregnant or lactating. * Baseline systolic BP \< 90 mmHg or cardiogenic shock * No symptoms of congestion or admission BNP \< 500 pg/mL * Known allergy to E.coli-derived products, or any history of anaphylactic reactions to nesiritide. * Receiving dialysis at the time of enrollment. * Serum creatinine \> 2.5 mg/dL at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal Function by Serum Creatinine | Baseline, 24 hours, 48 hours | Serum creatinine values and changes in serum creatinine |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Markers | 48 hours | Interleukin-6 |
| Serum Levels of Cystatin-C | Baseline, 24 hours, 48 hours | Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nesiritide Infusion 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours. | 45 |
| 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. | 44 |
| Total | 89 |
Baseline characteristics
| Characteristic | Nitroglycerin Infusion | Nesiritide Infusion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 26 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 19 Participants | 43 Participants |
| Age Continuous | 66.8 years STANDARD_DEVIATION 17.2 | 68.6 years STANDARD_DEVIATION 14.1 | 67.7 years STANDARD_DEVIATION 16.7 |
| Region of Enrollment United States | 44 participants | 45 participants | 89 participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 23 Participants | 25 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 44 |
| serious Total, serious adverse events | 12 / 45 | 12 / 44 |
Outcome results
Primary
Renal Function by Serum Creatinine
Serum creatinine values and changes in serum creatinine
Time frame: Baseline, 24 hours, 48 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide | Renal Function by Serum Creatinine | Serum creatinine at 48 hours | 1.3 mg/dL | Standard Deviation 0.4 |
| Nesiritide | Renal Function by Serum Creatinine | Serum creatinine at baseline | 1.3 mg/dL | Standard Deviation 0.4 |
| Nesiritide | Renal Function by Serum Creatinine | Serum creatinine at 24 hours | 1.3 mg/dL | Standard Deviation 0.4 |
| Nitroglycerin | Renal Function by Serum Creatinine | Serum creatinine at 24 hours | 1.4 mg/dL | Standard Deviation 0.4 |
| Nitroglycerin | Renal Function by Serum Creatinine | Serum creatinine at 48 hours | 1.4 mg/dL | Standard Deviation 0.5 |
| Nitroglycerin | Renal Function by Serum Creatinine | Serum creatinine at baseline | 1.3 mg/dL | Standard Deviation 0.4 |
Other Pre-specified
Inflammatory Markers
Interleukin-6
Time frame: 48 hours
Population: Only participants with available data were assessed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nesiritide | Inflammatory Markers | 25 pg/mL | Standard Error 7 |
| Nitroglycerin | Inflammatory Markers | 50 pg/mL | Standard Error 5 |
Other Pre-specified
Serum Levels of Cystatin-C
Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function.
Time frame: Baseline, 24 hours, 48 hours
Population: Only participants with available data were assessed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide | Serum Levels of Cystatin-C | Cystatin-C at Baseline | 1332 ng/mL | Standard Deviation 1308 |
| Nesiritide | Serum Levels of Cystatin-C | Cystatin-C at 24 Hours | 1475 ng/mL | Standard Deviation 1291 |
| Nesiritide | Serum Levels of Cystatin-C | Cystatin-C at 48 Hours | 1449 ng/mL | Standard Deviation 1298 |
| Nitroglycerin | Serum Levels of Cystatin-C | Cystatin-C at Baseline | 2026 ng/mL | Standard Deviation 1814 |
| Nitroglycerin | Serum Levels of Cystatin-C | Cystatin-C at 24 Hours | 3108 ng/mL | Standard Deviation 3761 |
| Nitroglycerin | Serum Levels of Cystatin-C | Cystatin-C at 48 Hours | 2739 ng/mL | Standard Deviation 3369 |