Heart Failure Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Multi-center Study Comparing CLP Versus Placebo in Heart Failure Patients With Chronic Kidney Disease
NCT number | NCT01265524 |
Other study ID # | CTST-21 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | December 20, 2010 |
Last updated | March 12, 2013 |
Start date | April 2011 |
The purpose of this study is to determine the effects of CLP on serum potassium and signs and symptoms of fluid overload in heart failure patients with chronic kidney disease.
Status | Completed |
Enrollment | 113 |
Est. completion date | |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Heart failure with New York Heart Association (NYHA) Classification III or IV - Hospitalization for heart failure decompensation associated with fluid overload within the last six months - Chronic kidney disease - Must be able to understand study procedures and willing and able to provide written informed consent Exclusion Criteria: - No hospitalization within 4 weeks of Baseline Visit - In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological or other disease or condition that makes the patients study participation unsafe - History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures - Current dialysis patient, or anticipated need for dialysis during study participation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sorbent Therapeutics | Pharmaterra |
Armenia, Georgia, Moldova, Republic of,
Costanzo MR, Heywood JT, Massie BM, Iwashita J, Henderson L, Mamatsashvili M, Sisakian H, Hayrapetyan H, Sager P, van Veldhuisen DJ, Albrecht D. A double-blind, randomized, parallel, placebo-controlled study examining the effect of cross-linked polyelectr — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Serum Potassium | Change in serum potassium from baseline to Week 8. | Baseline and 8 weeks | Yes |
Secondary | Weight Loss at Week 1 | Baseline and 1 week | No | |
Secondary | Weight Loss at Week 2 | Baseline and 2 weeks | No | |
Secondary | Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4 | The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4. | 4 weeks | No |
Secondary | Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8 | The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8. | 8 weeks | No |
Secondary | Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8 | Baseline and 8 weeks | Yes | |
Secondary | 6MWT Distance at Week 8 | Increase in the 6 minute walk test (6MWT) distance from baseline to Week 8. The test was performed according to the American Thoracic Society (ATS)Guidelines 2002. | Baseline and 8 weeks | No |
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