Back to resultsEvaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CLP
Spironolactone
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Heart failure with New York Heart Association (NYHA) Classification II or III
- 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:
- Hospitalization within 4 weeks of baseline visit
- 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
Sites / Locations
- Orange Country Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CLP with spironolactone
CLP without spironolactone
Arm Description
Outcomes
Primary Outcome Measures
Change in Fecal Sodium Content
Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)
Secondary Outcome Measures
Change in Fecal Weight
Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01598740
Brief Title
Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease
Official Title
A Phase 1, Open-label, Randomized, Crossover Study to Assess the Safety, Tolerability, and Efficacy of CLP With and Without Spironolactone in Adults With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorbent Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLP with spironolactone
Arm Type
Experimental
Arm Title
CLP without spironolactone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CLP
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Change in Fecal Sodium Content
Description
Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)
Time Frame
baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)
Secondary Outcome Measure Information:
Title
Change in Fecal Weight
Description
Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average)
Time Frame
baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Heart failure with New York Heart Association (NYHA) Classification II or III
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:
Hospitalization within 4 weeks of baseline visit
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Dittrich, MD
Organizational Affiliation
Sorbent Therapeutics, Study Sponsor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joel Neutel, MD
Organizational Affiliation
Orange County Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orange Country Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease
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