Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

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Otsuka

Status and phase

Completed
Phase 2

Conditions

Heart Failure, Congestive

Treatments

Drug: tolvaptan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00132886
156-04-247

Details and patient eligibility

About

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.).

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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