Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Tolvaptan

Criteria

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