Trial | NCT00132886  Report issue

Title

Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Single Oral Tolvaptan Tablets on Hemodynamic Parameters in Subjects With Heart Failure

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tolvaptan ...

  • Study Participants

    140
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.).
Study Started
Dec 31
2004
Primary Completion
Dec 31
2006
Study Completion
Dec 31
2006
Last Update
May 03
2012
Estimate

Drug 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
No Results Posted