Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sorbent Therapeutics
• Treatments: Spironolactone

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