Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

Phase 2

Completed

• Conditions: Heart Failure, Congestive

• Registration Number: NCT00132886
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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.).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-08-18
• Study First Submitted QC: 2005-08-18
• Study First Posted: 2005-08-22
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-02
• Last Update Posted: 2012-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in heart pressures (PCWP) at 3 to 8 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose
Adverse events, vital signs and clinical labs
Change in urine output and free water clearance
Cmax, tmax, and AUC 12h of tolvaptan in plasma
Change from baseline in urine osmolality

Trial Locations

Locations (31)

Oracle Research, A Div of the Heart Center; 🇺🇸 Huntsville, Alabama, United States

Merced Heart Associates; 🇺🇸 Merced, California, United States

Olive View-UCLA Medical Center; 🇺🇸 Sylmar, California, United States

Broward General Medical Center; 🇺🇸 Ft. Lauderdale, Florida, United States

Cardiovascular Center at Shands Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

ACRI; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Robert Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Loyola University of Chicago; 🇺🇸 Maywood, Illinois, United States

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