A clinical trial to study the effect of lixivaptan in the treatment of hyponatremia in NYHA Class III/IV Cardiac Patients

Phase 3

Active, not recruiting

• Registration Number: CTRI/2009/091/000319
• Lead Sponsor: Cardiokine Biopharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 650

Inclusion Criteria

1. Men and Women with age greater than or equal to 18 years.

2. Baseline serum sodium comcentration less than 135mEq/L.

3. Current hospitalization for worsening of chronic CHF.

4. The patient has clinical evidence of volume overload.

5. The patient has a documented left ventricular ejection fraction (LVEF) within the past year.

6. Supine systolic arterial blood pressure greater than or equal to 90mmHg.

Exclusion Criteria

1. Previous participation in this or any other Lixivaptan clinical trial.
2. Participation in any other investigational study within 30 days prior to screening.
3. Women who will not adhere to the reproductive precautions as outlined in the protocol and in the informed consent.
4. Positive urine pregnancy test.
5. Inability to provide informed consent.
6. Inability to respond to thirst.
7. Inability to take oral medications.
8. Acute severe hyponatremia.
9. Overt symptoms of hyponatremia requiring immediate medical intervention.
10. Hemodynamically significant uncorrected primary cardiac valvular disease.
11. Hypertrophic cardiomyopathy.
12. CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy.
13. History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
14. ST-segment elevation myocardial infarction within 30 days or active myocardial ischemia at the time of enrollment.
15. History of stroke within 30 days prior to screening.
16. History of cardiac revascularization procedure within 30 days prior to screening.
17. Patients who are on cardiac mechanical support.
18. History of bi-ventricular pacer placement within the last 30 days.
19. Planned revascularization procedures, electrophysiologic device implantation, cardiac support implantation, ultrafiltration or dialysis, or other cardiac surgery within 30 days following study enrollment.
20. Serum creatinine greater than 3.0 mg/dL/265.2mol/L.
21. Uncontrolled diabetes mellitus as defined by the investigator (eg. HbA1c > 9%).
22. Adrenal insufficiency, whether treated or not.
23. History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
24. History of chronic drug/medication abuse within 6 months; or current alcohol abuse.
25. Co-morbid condition with an expected survival of less than 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified