NCT00132886

Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00132886

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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.).

Eligibility

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

Disease(s) and\or Condition(s)

Heart Failure, Congestive

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: tolvaptan
- Description:
- Arm Group Labels:

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.