THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
- Registration Number
- NCT00578695
- Lead Sponsor
- CardioKine Inc.
- Brief Summary
The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 652
- Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Active lixivaptan Lixivaptan
- Primary Outcome Measures
Name Time Method To determine whether lixivaptan can effectively and safely produce an increase in serum sodium from Baseline in heart failure subjects with hyponatremia and volume overload. Effects on body weight and other clinical measures will be evaluated. 60 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
🇵🇱Sieradz, Poland
Shree Saibaba Heart Institute and Research Centre
🇮🇳Shalimar, Nashik, India
Research Site 2
🇵🇱Krakow, Poland
Hospital Militar Central H Gral. 601 "Cirujano Mayor Dr. Cosme Argerich"
🇦🇷Buenos Aires, Argentina
Research Site
🇨🇭Geneva, Switzerland
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Research Site 1
🇪🇸Vigo, Spain
Sri Ramachandra Medical College of research Institute
🇮🇳Tamul Nadu, India
Research SIte
🇵🇱Kielce, Poland
Hospital de Puerto Montt
🇨🇱Puerto Montt, Chile
Samodzielnl Szpital Wojewodzki
🇵🇱Piotrkow Trybunalski, Poland
Siant Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Research Site1
🇺🇸Sayre, Pennsylvania, United States
Sir Ganga Ram Hospital
🇮🇳New Delhi, India
hospital Interzonal General de Agudos, "Eva Peron" (HIGA)
🇦🇷San Martin, Buenos Aires, Argentina
Hospital de Clinicas "Jose de San Martin"
🇦🇷Buenos Aires, Argentina
Interna klinika, Fakultna nemocnica Trencin
🇸🇰Trencin, Slovakia
Azienda Ospedaliero-Universitaria "San Giovanni Battista di Torino" Struttura Complessa Cardiologia 1
🇮🇹Torino, Italy
Research SIte 1
🇷🇺Moscow, Russia, Russian Federation
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
Hospital Univeritario Virgen de la Victoria Servicio de Cardiologia
🇪🇸Malaga, Spain
Wojskowy Instytut Medyczny
🇵🇱Warszawa, Poland
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej
🇵🇱Ostroleka, Poland
Wojewodzki Szpital Specjalistczny w Radomiu, Oddzial Kardiologil
🇵🇱Radom, Poland