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Completed

NCT Number: NCT00132886

Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

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.).

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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institutul de Boli Cardiovasculare, Bucharest, Romania

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tolvaptan

Drug

Primary outcomes

  1. Change in heart pressures (PCWP) at 3 to 8 hours post-dose

Secondary outcomes

  1. Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose

  2. Change in urine output and free water clearance

  3. Change from baseline in urine osmolality

  4. Cmax, tmax, and AUC 12h of tolvaptan in plasma

  5. Adverse events, vital signs and clinical labs

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Aug 22, 2005
Registry last updated
May 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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