Trial · NCT00475852
A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure
NCT00475852, Phase 3, Completed, Scios, Inc.; results first posted 2012-05-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure. Trials, record NCT00475852. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00475852
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure
- NCT number
- NCT00475852
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7,141 participants, actual
- Lead sponsor
- Scios, Inc.
- Conditions
- Heart Decompensation
- Interventions
- Nesiritide, Placebo
- First posted
- 2007-05-21
- Last updated
- 2013-03-08
- Results first posted
- 2012-05-10
- Limitations and caveats
Only summary counts of deaths by group are provided for other pre-specified endpoints All-cause mortality through Day 30 and All-cause mortality through Day 180. Formal statistical comparisons were not planned.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality | Randomization to Day 30 | |
| Primary | Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug | 6 hours after initiation of study drug | Dyspnea symptoms were measured by patient self-assessed Likert scale at 6 hours after study drug initiation.The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.) |
| Primary | Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug | 24 hours after study drug initiation | Dyspnea symptoms were measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.) |
| Secondary | Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug | 6 hours after study drug initiation | Overall well-being was measured by patient self-assessed Likert scale at 6 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.) |
| Secondary | Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug | 24 hours after study drug initiation | Overall well-being was measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.) |
| Secondary | Composite of Persistent or Worsening Heart Failure and All-Cause Mortality | Randomization to hospital discharge (up to Day 30) | Clinical manifestations of worsening or persistent decompensated heart failure were defined by at least one of the following: new, persistent or worsening: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema, pulmonary basilar rales/crackles, jugular venous distension, renal hypoperfusion with no other apparent cause, or radiologic evidence of worsening heart failure. And was also defined by a new therapy specifically for the treatment of worsening or persistent decompensated heart failure. |
| Secondary | Number of Days Alive and Outside the Hospital | Randomization to Day 30 | |
| Secondary | Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality | Randomization to Day 30 | |
| Other | All-Cause Mortality Through Day 30 | Randomization to Day 30 | All deaths were adjudicated by an independent Clinical Events Committee. |
| Other | All-Cause Mortality Through Day 180 | Randomization to Day 180 | All deaths were adjudicated by an independent Clinical Events Committee. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality | Randomization to Day 30 | The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 164 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest. | Participants | NUMBER |
| PRIMARY | Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug | 6 hours after initiation of study drug | The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 148 and 133 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest. | Participants | NUMBER |
| PRIMARY | Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug | 24 hours after study drug initiation | The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 193 and 179 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest. | Participants | NUMBER |
| SECONDARY | Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug | 6 hours after study drug initiation | The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 158 and 147 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest. | Participants | NUMBER |
| SECONDARY | Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug | 24 hours after study drug initiation | The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 200 and 194 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest. | Participants | NUMBER |
| SECONDARY | Composite of Persistent or Worsening Heart Failure and All-Cause Mortality | Randomization to hospital discharge (up to Day 30) | The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 105 and 115 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest. | Participants | NUMBER |
| SECONDARY | Number of Days Alive and Outside the Hospital | Randomization to Day 30 | The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 182 and 188 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest. | Days | MEAN |
| SECONDARY | Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality | Randomization to Day 30 | The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 162 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | All-Cause Mortality Through Day 30 | Randomization to Day 30 | The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | All-Cause Mortality Through Day 180 | Randomization to Day 180 | The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population. | Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality | Nesiritide | 321 | Participants | ||
| Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality | Placebo | 345 | Participants | ||
| Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug | Nesiritide | Markedly Better | 513 | Participants | |
| Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug | Placebo | Markedly Better | 460 | Participants | |
| Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug | Nesiritide | Moderately Better | 1007 | Participants | |
| Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug | Placebo | Moderately Better | 989 | Participants | |
| Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug | Nesiritide | Minimally Better | 1119 | Participants | |
| Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug | Placebo | Minimally Better | 1174 | Participants | |
| Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug | Nesiritide | No Change | 692 | Participants | |
| Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug | Placebo | No Change | 748 | Participants |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nesiritide | 3,564 | |
| Overall Study | STARTED | Placebo | 3,577 | |
| Overall Study | COMPLETED | Nesiritide | 3,047 | |
| Overall Study | COMPLETED | Placebo | 3,029 | |
| Overall Study | NOT COMPLETED | Nesiritide | 517 | |
| Overall Study | NOT COMPLETED | Placebo | 548 |
Source ClinicalTrials.gov
Adverse events564
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Nesiritide | 2 | 3,498 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 4 | 3,509 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Nesiritide | 0 | 3,498 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 2 | 3,509 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nesiritide | 1 | 3,498 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 0 | 3,509 | |
| other | Aortic Valve Stenosis | Cardiac disorders | Nesiritide | 1 | 3,498 | |
| other | Aortic Valve Stenosis | Cardiac disorders | Placebo | 0 | 3,509 | |
| other | Arrhythmia Supraventricular | Cardiac disorders | Nesiritide | 6 | 3,498 | |
| other | Arrhythmia Supraventricular | Cardiac disorders | Placebo | 4 | 3,509 |
1 to 10 of 564Source ClinicalTrials.gov
See all 564 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nesiritide | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Nesiritide | 366 | 3,498 |
| Total, other adverse events | Placebo | 364 | 3,509 |
| Total, serious adverse events | Nesiritide | 5 | 3,498 |
| Total, serious adverse events | Placebo | 2 | 3,509 |
Source ClinicalTrials.gov
Papers21
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nesiritide vs Placebo: Number of Patients With Renal Impairment | Trial comparisons |
| Nesiritide vs Placebo: Composite of Persistent or Worsening Heart Failure and All-Cause Mortality | Trial comparisons |
| Nesiritide vs Placebo: All-Cause Mortality Through Day 30 | Trial comparisons |
| Nesiritide vs Placebo: Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality | Trial comparisons |
| Nesiritide vs Placebo: Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality | Trial comparisons |
| Nesiritide vs Placebo: All-Cause Mortality Through Day 180 | Trial comparisons |
| Nesiritide vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00475852
GET https://conductscience.org/api/trials/v1/NCT00475852/results?page=2