Trial · NCT00843986
Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)
NCT00843986, Phase 3, Terminated, Cumberland Pharmaceuticals; results first posted 2010-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF). Trials, record NCT00843986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00843986
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)
- NCT number
- NCT00843986
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 9 participants, actual
- Lead sponsor
- Cumberland Pharmaceuticals
- Conditions
- Hyponatremia, Acute Decompensated Heart Failure
- Interventions
- conivaptan, placebo
- First posted
- 2009-02-13
- Last updated
- 2014-05-15
- Results first posted
- 2010-10-01
- Limitations and caveats
The study was terminated because of difficulties in enrolling eligible patients per the protocol inclusion and exclusion criteria.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation) | Baseline and 72 Hours | MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Primary | Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale | 24 Hours | Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Change in Renal Function From Baseline at Hours 24, 48 and 72 as Assessed by Urine Creatinine Clearance | Baseline, 24 Hours, 48 Hours and 72 Hours | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Change in Renal Function From Baseline at Hours 24, 48 and Day 9 (or Day of Discharge) as Assessed by Serum Creatinine Concentration and Calculated Creatinine Clearance | Baseline, 24 Hours, 48 Hours and Day 9 | Calculated creatinine clearance is only calculated through hour 72 using the MDRD equation. MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Incidence of Use of Rescue Therapy or Other Intervention (Including Dialysis) Because of Worsening Renal Function | Day 9 | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Termination of Study Drug Due to an Adverse Event or Intolerability | 48.5 Hours | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Relative Dyspnea Assessment | Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours | Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point Likert scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Provocative Dyspnea Assessment | Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours | Dyspnea is defined as the sensation of uncomfortable or difficult breathing. The Provocative Dyspnea Assessment assesses dyspnea and changes in dyspnea from Baseline on a 5-point Likert scale at 5 different positions and assigns a Dyspnea Severity Score that ranges from 1 (worst severity) to 25 (least severity). Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Change From Baseline in Body Weight at Hours 24, 48 and 72 and Days 6 and 9 (or Day of Discharge) | Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9 | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Total Loop Diuretic Use Through 48 Hours | 48 Hours | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation) | Baseline and 72 Hours | Study was terminated - assessment of this Outcome Measure was not performed. | ||
| PRIMARY | Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale | 24 Hours | Study was terminated - assessment of this Outcome Measure was not performed. | ||
| SECONDARY | Change in Renal Function From Baseline at Hours 24, 48 and 72 as Assessed by Urine Creatinine Clearance | Baseline, 24 Hours, 48 Hours and 72 Hours | Study was terminated - assessment of this Outcome Measure was not performed. | ||
| SECONDARY | Change in Renal Function From Baseline at Hours 24, 48 and Day 9 (or Day of Discharge) as Assessed by Serum Creatinine Concentration and Calculated Creatinine Clearance | Baseline, 24 Hours, 48 Hours and Day 9 | Study was terminated - assessment of this Outcome Measure was not performed. | ||
| SECONDARY | Incidence of Use of Rescue Therapy or Other Intervention (Including Dialysis) Because of Worsening Renal Function | Day 9 | Study was terminated - assessment of this Outcome Measure was not performed. | ||
| SECONDARY | Termination of Study Drug Due to an Adverse Event or Intolerability | 48.5 Hours | Study was terminated - assessment of this Outcome Measure was not performed. | ||
| SECONDARY | Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Relative Dyspnea Assessment | Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours | Study was terminated - assessment of this Outcome Measure was not performed. | ||
| SECONDARY | Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Provocative Dyspnea Assessment | Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours | Study was terminated - assessment of this Outcome Measure was not performed. | ||
| SECONDARY | Change From Baseline in Body Weight at Hours 24, 48 and 72 and Days 6 and 9 (or Day of Discharge) | Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9 | Study was terminated - assessment of this Outcome Measure was not performed. | ||
| SECONDARY | Total Loop Diuretic Use Through 48 Hours | 48 Hours | Study was terminated - assessment of this Outcome Measure was not performed. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 3 | |
| Overall Study | STARTED | Conivaptan | 6 | |
| Overall Study | Completed Treatment (Infusion) | Placebo | 2 | |
| Overall Study | Completed Treatment (Infusion) | Conivaptan | 6 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | COMPLETED | Conivaptan | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Conivaptan | 1 |
Source ClinicalTrials.gov
Adverse events26
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 | Atrial flutter | Cardiac disorders | Placebo | 0 | 3 | |
| other | Atrial flutter | Cardiac disorders | Conivaptan | 1 | 6 | |
| other | Ventricular tachycardia | Cardiac disorders | Placebo | 0 | 3 | |
| other | Ventricular tachycardia | Cardiac disorders | Conivaptan | 1 | 6 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 3 | |
| other | Constipation | Gastrointestinal disorders | Conivaptan | 1 | 6 | |
| other | Infusion site erythema | General disorders | Placebo | 0 | 3 | |
| other | Infusion site erythema | General disorders | Conivaptan | 3 | 6 | |
| other | Infusion site pain | General disorders | Placebo | 0 | 3 | |
| other | Infusion site pain | General disorders | Conivaptan | 1 | 6 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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 | Conivaptan | ||
| Total, other adverse events | Placebo | 1 | 3 |
| Total, other adverse events | Conivaptan | 5 | 6 |
| Total, serious adverse events | Placebo | 1 | 3 |
| Total, serious adverse events | Conivaptan | 1 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Conivaptan 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/NCT00843986
GET https://conductscience.org/api/trials/v1/NCT00843986/events?page=2