Heart Failure
Conditions
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.
Interventions
DRUGCLP
Oral administration
DRUGSpironolactone
oral administration
Sponsors
Sorbent Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fecal Sodium Content | baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32) | Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fecal Weight | baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32) | Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average) |
Countries
United States
Participant flow
Recruitment details
The first subject was enrolled on 01 June 2012 and the last subject completed on 06 August 2012. The study was completed at one research center.
Pre-assignment details
Each study period included a 5-day baseline period followed by a 7-day treatment period. The study periods were separated by a 7-day washout period.
Participants by arm
| Arm | Count |
|---|---|
| CLP + Spiro/CLP Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2. | 9 |
| CLP/CLP + Spiro Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | CLP + Spiro/CLP | CLP/CLP + Spiro | Total |
|---|---|---|---|
| Age Continuous | 56.3 years STANDARD_DEVIATION 7.58 | 63.4 years STANDARD_DEVIATION 9.77 | 59.9 years STANDARD_DEVIATION 8.7 |
| Diet High sodium | 7 participants | 6 participants | 13 participants |
| Diet Low sodium | 1 participants | 2 participants | 3 participants |
| Diet Medium sodium | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 13 Participants |
| Weight | 91.35 kg STANDARD_DEVIATION 24.2 | 99.54 kg STANDARD_DEVIATION 27.49 | 95.4 kg STANDARD_DEVIATION 25.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 16 | 8 / 18 |
| serious Total, serious adverse events | 0 / 16 | 0 / 18 |
Outcome results
Primary
Change in Fecal Sodium Content
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group: CLP Alone | Change in Fecal Sodium Content | 635.10 mg | Standard Deviation 441.11 |
| Treatment Group: CLP + Spironolactone | Change in Fecal Sodium Content | 501.95 mg | Standard Deviation 342.52 |
Comparison: One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.p-value: 0.0662ANCOVA
Secondary
Change in Fecal Weight
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group: CLP Alone | Change in Fecal Weight | 144.7 grams | Standard Deviation 86.5 |
| Treatment Group: CLP + Spironolactone | Change in Fecal Weight | 119.0 grams | Standard Deviation 106.98 |
Comparison: One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.p-value: 0.1899ANCOVA