Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated H… (NCT00843986) | Clinical Trial Compass
TerminatedPhase 3
Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)
Stopped: The clinical study has been terminated based on difficulties to enroll eligible subjects per protocol inclusion and exclusion criteria.
India9 participantsStarted 2009-04
Plain-language summary
This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presents to emergency department with documented history of CHF and symptomatic ADHF, will be treated for ADHF, and primary reason for admission to the hospital is ADHF
* Dyspnea at rest or with minimal exertion and must have moderate shortness of breath (SOB) in any of the first three Provocative Dyspnea Assessment positions
* Severe pulmonary congestion as evidenced by jugular venous distention or lower extremity/sacral edema or rales upon chest auscultation or chest x-ray.
* BNP \> 400 or NT-pro BNP \> 1500 drawn during Screening
* Systolic blood pressure \>= 100 mmHg to \< 180 mmHg at time of start of study drug
* Serum sodium value \>= 115 mEq/L (115 mmol/L) and \< 135 mEq/L (135 mmol/L) during Screening
Exclusion Criteria:
* Clinical evidence of volume depletion
* Active ongoing acute coronary syndrome or acute ST segment elevation myocardial infarction (or has experienced a myocardial infarction within 30 days of Screening)
* In cardiogenic shock
* Calculated creatinine clearance \< 30 mL/min/1.73 m2 as estimated by the Modification of Diet in Renal Disease (MDRD) equation, has received intravenous (IV) contrast agent within 72 hours prior to randomization or is expected to receive IV contrast agent within the first 72 hours of study participation
* Ultrafiltration within the past 72 hours.
* Currently using or expected to use inotropic therapy
* Cardiac bypass grafts in the past 60 days
* Cerebrovascular accident in the past 30 days
* Uncontro…
What they're measuring
1
Change in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation)
Timeframe: Baseline and 72 Hours
2
Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale