Heart Failure, Congestive
Conditions
Brief summary
This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.).
Interventions
DRUGtolvaptan
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Class III or IV heart failure for at least 3 months * Left ventricular ejection fraction less than or equal to 40% * Currently being treated for heart failure with standard therapies for at least one month
Exclusion criteria
* Women who are pregnant or breastfeeding * Inability to take oral medications * Uncontrolled hypertension, bradyarrhythmias or tachyarrhythmias * Hypertrophic obstructive cardiomyopathy * Severe obstructive pulmonary disease * Significant renal impairment * Significant uncorrected valvular or congenital heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in heart pressures (PCWP) at 3 to 8 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose | — |
| Change in urine output and free water clearance | — |
| Change from baseline in urine osmolality | — |
| Cmax, tmax, and AUC 12h of tolvaptan in plasma | — |
| Adverse events, vital signs and clinical labs | — |
Countries
Romania, United States
Outcome results
None listed