Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF) (CONVERT-H)

Cumberland Pharmaceuticals

Status and phase

Terminated

Phase 3

Conditions

Acute Decompensated Heart Failure

Hyponatremia

Treatments

Drug: conivaptan

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00843986

087-CL-301

Details and patient eligibility

About

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).

Full description

Subjects will be recruited from the Emergency Department. It is expected that subjects will be treated according to the institution's accepted conventional therapy protocol for the treatment of ADHF. Therapy may also include the use of loop diuretics for the relief of pulmonary congestion and maintenance of adequate urine output.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Uncontrolled brady- or ventricular tachyarrhythmias requiring emergent pacemaker placement or treatment
Hemodynamically significant uncorrected primary cardiac valvular disease or hypertrophic cardiomyopathy
Untreated severe hypothyroidism, hyperthyroidism or adrenal insufficiency based on medical history
ALT or AST elevations > 5 times upper limit of normal
Biliary liver cirrhosis, history or presence of severe hepatic encephalopathy, ascites, esophageal variceal bleeding within the past three months, severe portal hypertension or surgical portosystemic shunt.
Received any organ transplant, clinical diagnosis of pneumonia, symptomatic hyponatremia requiring urgent intervention or any concurrent illness which, in the opinion of the investigator, may interfere with treatment or evaluation of safety
Pregnant or lactating
Currently using vasopressin, oxytocin or desmopressin