Trial · NCT00387621
Natriuretic Peptide System as Therapy in Human Preclinical Left Ventricle Dysfunction
NCT00387621, Phase 1, Phase 2, Completed, Horng Chen; results first posted 2012-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Natriuretic Peptide System as Therapy in Human Preclinical Left Ventricle Dysfunction. Trials, record NCT00387621. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00387621
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Natriuretic Peptide System as Therapy in Human Preclinical Left Ventricle Dysfunction
- NCT number
- NCT00387621
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- Horng Chen
- Conditions
- Congestive Heart Failure
- Interventions
- Nesiritide, Placebo, Saline
- First posted
- 2006-10-13
- Last updated
- 2012-05-17
- Results first posted
- 2012-05-17
- Limitations and caveats
* Different baseline characteristics of the three groups of subjects~* Did not define a mechanism for the impaired renal cGMP activation~* Future studies needed to determine effects of chronic nesiritide therapy in preclinical HF.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Natriuresis (Urinary Sodium Excretion) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment | baseline and 60 minutes | Value at 60 minutes minus value at baseline. |
| Primary | Placebo Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UnaV) | Baseline, 30 min, 60 min | Subjects received subcutaneous placebo in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UNaV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE. |
| Primary | Placebo Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV) | Baseline, 30 min, 60 min | Subjects received subcutaneous placebo in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UcGMPV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE. |
| Primary | Nesiritide Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UNaV) | Baseline, 30 min, 60 min | Subjects received subcutaneous Nesiritide in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UNaV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE. |
| Primary | Nesiritide Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV) | Baseline, 30 min, 60 min | Subjects received subcutaneous Nesiritide in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UcGMPV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE. |
| Secondary | Change in Urinary Cyclic Guanosine Monophosphate (cGMP) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment | baseline and 60 minutes | Value at 60 minutes minus value at baseline |
| Secondary | Change in Natriuresis (Urinary Sodium Excretion) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | 30 minutes | Value of natriuresis at 30 min on nesiritide treatment minus value of natriuresis at 30 min on placebo treatment (per subject group). The baseline was not involved in this calculation. |
| Secondary | Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | 60 minutes | Value of natriuresis at 60 min on nesiritide treatment minus value of natriuresis at 60 min on placebo treatment (per subject group). The baseline was not involved in this calculation. |
| Secondary | Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | 30 minutes | Value of cGMP at 30 min on nesiritide treatment minus value of cGMP at 30 min on placebo treatment (per subject group). The baseline was not involved in this calculation. |
| Secondary | Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | 60 minutes | Value of cGMP at 60 min on nesiritide treatment minus value of cGMP at 60 min on placebo treatment (per subject group). The baseline was not involved in this calculation. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Natriuresis (Urinary Sodium Excretion) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment | baseline and 60 minutes | per protocol | mEq/min | MEAN |
| SECONDARY | Change in Urinary Cyclic Guanosine Monophosphate (cGMP) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment | baseline and 60 minutes | intention to treat (ITT) | pmol/min | MEAN |
| SECONDARY | Change in Natriuresis (Urinary Sodium Excretion) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | 30 minutes | intention to treat (ITT) | mEq/min | MEAN |
| SECONDARY | Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | 60 minutes | intention to treat (ITT) | mEq/min | MEAN |
| SECONDARY | Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | 30 minutes | intention to treat (ITT) | pmol/min | MEAN |
| SECONDARY | Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | 60 minutes | pmol/min | MEAN | |
| PRIMARY | Placebo Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UnaV) | Baseline, 30 min, 60 min | uEq/min | MEAN | |
| PRIMARY | Placebo Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV) | Baseline, 30 min, 60 min | pmol/min | MEAN | |
| PRIMARY | Nesiritide Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UNaV) | Baseline, 30 min, 60 min | uEq/min | MEAN | |
| PRIMARY | Nesiritide Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV) | Baseline, 30 min, 60 min | pmol/min | MEAN |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Natriuresis (Urinary Sodium Excretion) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment | Control Group | 87.19 | Standard Error 22.26 | mEq/min | |
| Change in Urinary Cyclic Guanosine Monophosphate (cGMP) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment | Control Group | 98.23 | Standard Error 34.12 | pmol/min | |
| Change in Natriuresis (Urinary Sodium Excretion) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | Control | 440.93 | Standard Error 76.67 | mEq/min | |
| Change in Natriuresis (Urinary Sodium Excretion) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | PSD-Preclinical Systolic Dysfunction | 261.07 | Standard Error 101.60 | mEq/min | |
| Change in Natriuresis (Urinary Sodium Excretion) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | PDD-Preclinical Diastolic Dysfunction | 242.82 | Standard Error 68.58 | mEq/min | |
| Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | Control | 183.83 | Standard Error 60.60 | mEq/min | |
| Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | PSD-Preclinical Systolic Dysfunction | 226.89 | Standard Error 101.72 | mEq/min | |
| Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | PDD-Preclinical Diastolic Dysfunction | 41.55 | Standard Error 46.07 | mEq/min | |
| Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | Control | 244.69 | Standard Error 59.09 | pmol/min | |
| Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment | PSD-Preclinical Systolic Dysfunction | 255.31 | Standard Error 59.60 | pmol/min |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Placebo First, Then Nesiritide (Arm A) | 29 | |
| First Intervention | STARTED | Nesiritide First, Then Placebo (Arm B) | 29 | |
| First Intervention | COMPLETED | Placebo First, Then Nesiritide (Arm A) | 29 | |
| First Intervention | COMPLETED | Nesiritide First, Then Placebo (Arm B) | 29 | |
| First Intervention | NOT COMPLETED | Placebo First, Then Nesiritide (Arm A) | 0 | |
| First Intervention | NOT COMPLETED | Nesiritide First, Then Placebo (Arm B) | 0 | |
| Washout Period of 2 Weeks | STARTED | Placebo First, Then Nesiritide (Arm A) | 29 | |
| Washout Period of 2 Weeks | STARTED | Nesiritide First, Then Placebo (Arm B) | 29 | |
| Washout Period of 2 Weeks | COMPLETED | Placebo First, Then Nesiritide (Arm A) | 29 | |
| Washout Period of 2 Weeks | COMPLETED | Nesiritide First, Then Placebo (Arm B) | 29 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events20
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 | re-stenosis | Cardiac disorders | Placebo | 0 | 58 | 0 |
| other | re-stenosis | Cardiac disorders | Nesiritide | 1 | 58 | 1 |
| other | heart palpatations | Cardiac disorders | Placebo | 0 | 58 | 0 |
| other | heart palpatations | Cardiac disorders | Nesiritide | 1 | 58 | 1 |
| other | afibrillation | Cardiac disorders | Placebo | 1 | 58 | 1 |
| other | afibrillation | Cardiac disorders | Nesiritide | 0 | 58 | 0 |
| other | atypical chest pain | Cardiac disorders | Placebo | 1 | 58 | 1 |
| other | atypical chest pain | Cardiac disorders | Nesiritide | 0 | 58 | 0 |
| other | diarrhea | Gastrointestinal disorders | Placebo | 2 | 58 | 2 |
| other | diarrhea | Gastrointestinal disorders | Nesiritide | 0 | 58 | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Nesiritide | ||
| Total, other adverse events | Placebo | 5 | 58 |
| Total, other adverse events | Nesiritide | 6 | 58 |
| Total, serious adverse events | Placebo | 0 | 58 |
| Total, serious adverse events | Nesiritide | 1 | 58 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22051332 | BACKGROUND |
Source PubMed
Grants3
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01HL084155 | Human Cardiorenal Syndrome | CHEN, HORNG H | MAYO CLINIC ROCHESTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2009 to 2025 | NIH RePORTER |
| P01HL076611 | Biology and Novel Therapeutics of Cardiovascular Peptides | BURNETT, JOHN C | MAYO CLINIC ROCHESTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2005 to 2015 | NIH RePORTER |
| UL1RR024150 | Mayo Clinic Center for Translational Science Activities | RIZZA, ROBERT A. | MAYO CLINIC ROCHESTER | NATIONAL CENTER FOR RESEARCH RESOURCES | 2006 to 2011 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Nesiritide vs Placebo: serious adverse events |
Source 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/NCT00387621
GET https://conductscience.org/api/trials/v1/NCT00387621/results?page=2