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

Phase 1

Completed

• Conditions: Heart Failure
• Interventions: Drug: CLP; Drug: Spironolactone

• Registration Number: NCT01598740
• Lead Sponsor: Sorbent Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-11
• Study First Submitted QC: 2012-05-11
• Study First Posted: 2012-05-15
• Study Start: 2012-06
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2013-03-22
• Results First Submitted QC: 2013-03-22
• Results First Posted: 2013-05-08
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-12
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CLP with spironolactone	Spironolactone	-
CLP without spironolactone	CLP	-
CLP with spironolactone	CLP	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Orange Country Research Center; 🇺🇸 Tustin, California, United States