Congestive Heart FailurePhase 2NCT01055912
Study to Evaluate the Effects of Oral Administration of Lixivaptan in Patients With Congestive Heart Failure
A Phase 2 study testing Lixivaptan in people with Congestive Heart Failure, run by CardioKine Inc. at 25 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects of oral lixivaptan capsules in patients with congestive heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Lixivaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 25 sitesUnited States
- Study dates
- Jan 2010to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Executive Health and Research Associates, Inc
Atlanta, Georgia, 30342
Maine Research Associates
Auburn, Maine, 04210
Fox Valley Clinical Research Center
Aurora, Illinois, 60504
Primary Care Cardiology Research, Inc
Ayer, Massachusetts, 01432
Clinical Research Limited
Canton, Ohio, 44718
Capitol Interventional Cardiology
Carmichael, California, 95608
Innovative Research of West Florida, Inc
Clearwater, Florida, 33756
Cardiovascular Research Institute of Dallas
Dallas, Texas, 75231
Dayton Heart Center
Dayton, Ohio, 45414
In-Quest Medical Research, LLC
Duluth, Georgia, 30096
Edgewater Medical Research Inc
Edgewater, Florida, 32141
East Texas Cardiology
Houston, Texas, 77002
Nea Clinic
Jonesboro, Arkansas, 72401
Foundation/Research/Cardiovascular Specialists Lower Keys
Key West, Florida, 33040
Merced Heart Associates
Merced, California, 95340
Mobile Heart Specialists, PC
Mobile, Alabama, 36608
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 23502
Orange County Heart Institute and Research Center
Orange, California, 92868
Phoenix Clinical
Phoenix, Arizona, 85029
Charlotte Heart Group Research Center
Port Charlotte, Florida, 33952
Raleigh Cardiology
Raleigh, North Carolina, 27610
National Clinical Research - Richmond
Richmond, Virginia, 23294
Horizon Research
St Louis, Missouri, 63141
Tampa Clinical Research
Tampa, Florida, 33624
Great Lakes Medical Research
Westfield, New York, 14787
About this study
Official title: 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.
Read the 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.
- Conditions
- Congestive Heart Failure
- Being tested
- Lixivaptan, Placebo
- Keywords
- Congestive Heart Failure, Volume Overload
- Medical subject headings
- Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LixivaptanDrug
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.
PlaceboDrug
Patients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Lixivaptan | Experimental | Capsule, 100mg Lixivaptan or matching placebo once daily. Receives: Drug: Lixivaptan |
| Placebo | Placebo comparator | Patients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy and safety of lixivaptan treatment in congestive heart failure (CHF) patients with volume expansion.
Measured: 8 weeks
Secondary outcomes (1)
To assess the effects of lixivaptan treatment in CHF patients with volume expansion.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioKine Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardiokine Biopharma, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055912
- Sponsor's protocol ID
- CK-LX2401
- Status last verified
- Nov 2010
- First submitted
- 22 Jan 2010
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ghali JK, Orlandi C, Abraham WT; CK-LX2401 Study Investigators. The efficacy and safety of lixivaptan in outpatients with heart failure and volume overload: results of a multicentre, randomized, double-blind, placebo-controlled, parallel-group study. Eur J Heart Fail. 2012 Jun;14(6):642-51. doi: 10.1093/eurjhf/hfs051. Epub 2012 Apr 17.
PubMed 22510424
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01055912
- Acronym / sponsor ID
- CK-LX2401
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure, Volume Overload
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- CardioKine Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cardiokine Biopharma, LLC
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of oral lixivaptan capsules in patients with congestive heart failure.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lixivaptan | Experimental | Drug: LixivaptanCapsule, 100mg Lixivaptan or matching placebo once daily. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LixivaptanCapsule. 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. | Drug | Lixivaptan |
| PlaceboPatients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo. | Drug | Placebo |
Primary outcome
To assess the efficacy and safety of lixivaptan treatment in congestive heart failure (CHF) patients with volume expansion.
Time frame: 8 weeks
1 secondary outcome
To assess the effects of lixivaptan treatment in CHF patients with volume expansion.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Derived from this study: PubMed 22510424Ghali JK, Orlandi C, Abraham WT; CK-LX2401 Study Investigators. The efficacy and safety of lixivaptan in outpatients with heart failure and volume overload: results of a multicentre, randomized, double-blind, placebo-controlled, parallel-group study. Eur J Heart Fail. 2012 Jun;14(6):642-51. doi: 10.1093/eurjhf/hfs051. Epub 2012 Apr 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lixivaptan in people with Congestive Heart Failure, run by CardioKine Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy and safety of lixivaptan treatment in congestive heart failure (CHF) patients with volume expansion. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01055912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.