Study to Evaluate the Effects of Oral Administration of Lixivaptan in Patients With Congestive Heart Failure

June 20, 2011 updated by: CardioKine Inc.

Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Efficacy and Safety Study to Evaluate the Effects of Oral Administration of Lixivaptan in Patients With Congestive Heart Failure

The purpose of this study is to evaluate the effects of oral lixivaptan capsules in patients with congestive heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diuretics are used extensively in the treatment of patients with CHF, and their efficacy is well established. However, there is a tendency for currently used diuretics to increase afterload and deplete electrolytes, and in many patients ventricular function continues to deteriorate over time.

Loop diuretics, such as furosemide, also have known negative effects on renal function reducing the glomerular filtration rate, and have been shown to activate the RAA system.

Lixivaptan is a potent, non-peptide selective antagonist of the vasopressin V2 receptor.

Lixivaptan treatment results in increased free water excretion, thus decreasing urine osmolality, increasing urine flow, and increasing serum osmolality. Short-term treatment with lixivaptan has demonstrated improved fluid management and electrolyte balance in HF patients.

This study was designed to assess the effects of vasopressin blockade with lixivaptan in patients with CHF with volume overload. A placebo-control arm will allow for assessment of the effect of lixivaptan in addition to standard diuretic therapy as compared with standard diuretic therapy alone.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Mobile Heart Specialists, PC
    • Arizona
      • Phoenix, Arizona, United States, 85029
        • Phoenix Clinical
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Clinic
    • California
      • Carmichael, California, United States, 95608
        • Capitol Interventional Cardiology
      • Merced, California, United States, 95340
        • Merced Heart Associates
      • Orange, California, United States, 92868
        • Orange County Heart Institute and Research Center
    • Florida
      • Clearwater, Florida, United States, 33756
        • Innovative Research Of West Florida, Inc
      • Edgewater, Florida, United States, 32141
        • Edgewater Medical Research Inc
      • Key West, Florida, United States, 33040
        • Foundation/Research/Cardiovascular Specialists Lower Keys
      • Port Charlotte, Florida, United States, 33952
        • Charlotte Heart Group Research Center
      • Tampa, Florida, United States, 33624
        • Tampa Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Executive Health and Research Associates, Inc
      • Duluth, Georgia, United States, 30096
        • In-Quest Medical Research, LLC
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Fox Valley Clinical Research Center
    • Maine
      • Auburn, Maine, United States, 04210
        • Maine Research Associates
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
        • Primary Care Cardiology Research, Inc
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Horizon Research
    • New York
      • Westfield, New York, United States, 14787
        • Great Lakes Medical Research
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Raleigh Cardiology
    • Ohio
      • Canton, Ohio, United States, 44718
        • Clinical Research Limited
      • Dayton, Ohio, United States, 45414
        • Dayton Heart Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Cardiovascular Research Institute of Dallas
      • Houston, Texas, United States, 77002
        • East Texas Cardiology
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • National Clinical Research - Norfolk, Inc.
      • Richmond, Virginia, United States, 23294
        • National Clinical Research - Richmond

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and to provide signed and dated informed consent.
  • Men and women aged 18 years or older.
  • History of chronic CHF defined as requiring standard HF treatment (including diuretics) for a minimum of 30 days.
  • Documented LVEF by any method within 12 months prior to screening.

  • The patient has clinical evidence of volume overload at the time of inclusion with at least one of the following:

    • Dyspnea
    • Pulmonary congestion (rales)
    • Peripheral edema
    • Increased jugular venous pressure and/or hepatic congestion with ascites
    • Chest x-ray consistent with CHF
    • Plasma brain natriuretic peptide (BNP) ≥150 pg/mL or N-terminal prohormone brain natriuretic peptide (NT pro-BNP) ≥450 pg/mL

Exclusion Criteria:

  • Women who are pregnant (positive pregnancy test), breastfeeding, or who will not adhere to the reproductive precautions as outlined in this protocol and in the informed consent form (ICF).
  • Sustained (three blood pressure measurements over 1 hour) systolic blood pressure <90 mmHg at Screening or Day 0.
  • ST segment elevation myocardial infarction or stroke within 30 days prior to Screening.
  • Hemodynamically destabilizing cardiac arrhythmia within 30 days prior to Day 0.
  • Clinically significant valvular disease.
  • Known clinically significant obstructive, restrictive, or hypertrophic cardiomyopathy.
  • Cardiac surgery or percutaneous coronary intervention within 30 days prior to Day 0.
  • Major surgical procedure within 7 days prior to Day 0.
  • Likely to undergo cardiac transplantation, left ventricular assist device (LVAD) or other device implantation, or other cardiac surgery within 3 months after Screening.
  • Placement of implantable cardioverter defibrillator or cardiac resynchronization therapy device within 60 days prior to Day 0.
  • CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid cardiomyopathy.
  • Presence of any clinically significant (as determined by the Investigator) endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, oncologic, and/or other major disease that might interfere with safe and compliant participation in this study.

  • Screening laboratory findings as follows:

    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal
    • Total bilirubin >2.0 mg/dL
    • Serum creatinine >3.0 mg/dL
    • Hemoglobin <9.0 g/dL
  • Uncontrolled diabetes mellitus as defined by the Investigator (e.g., glycosylated hemoglobin [HbA1c] >9%).
  • History of chronic drug/medication abuse within the past 6 months; or current alcohol abuse.
  • Co-morbid condition with an expected survival of less than 3 months.
  • Known allergy to any vasopressin antagonist or any condition for which treatment with a vasopressin antagonist may present undue risk to the patient.
  • Current or recent administration (within 7 days of Day 0) of prohibited medications as listed in Section 8.6.4 .
  • Participation in any other investigational study of drugs or devices within 30 days prior to Screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lixivaptan
Capsule, 100mg Lixivaptan or matching placebo once daily.
Drug: Lixivaptan
Capsule. Patients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo. One hundred (100) patients will be randomized to receive lixivaptan 100 mg once daily (QD) for 8 weeks. Fifty (50) placebo patients will receive matching oral placebo for 8 weeks.
Placebo Comparator: Placebo
Patients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo.
Drug: Placebo
Patients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy and safety of lixivaptan treatment in congestive heart failure (CHF) patients with volume expansion.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the effects of lixivaptan treatment in CHF patients with volume expansion.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioKine Inc.

Collaborators

Cardiokine Biopharma, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 22, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

June 28, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CK-LX2401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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