Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease
NCT ID: NCT01598740
Last Updated: 2013-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2012-06-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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CLP with spironolactone
CLP
Oral administration
Spironolactone
oral administration
CLP without spironolactone
CLP
Oral administration
Interventions
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CLP
Oral administration
Spironolactone
oral administration
Eligibility Criteria
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Inclusion Criteria
* Chronic kidney disease
* Cardiac ejection fraction \<40%
* On heart failure therapy including an ACEI or ARB, and a BB
* Willing to understand and comply with study procedures and provide written informed consent.
Exclusion Criteria
* History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
* Current or anticipated dialysis during study
* In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological, or other disease or condition that makes the subject's study participation unsafe
* Drug or alcohol abuse
18 Years
ALL
No
Sponsors
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Sorbent Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Howard Dittrich, MD
Role: STUDY_CHAIR
Sorbent Therapeutics, Study Sponsor
Joel Neutel, MD
Role: PRINCIPAL_INVESTIGATOR
Orange County Research Center
Locations
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Orange Country Research Center
Tustin, California, United States
Countries
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Other Identifiers
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CTST-25
Identifier Type: -
Identifier Source: org_study_id
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