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

Sorbent Therapeutics

Status and phase: Completed; Phase 1

Conditions: Heart Failure

Treatments: Drug: Spironolactone; Drug: CLP

Study type: Interventional

Funder types: Industry

Identifiers

NCT01598740

CTST-25

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

CLP with spironolactone

Experimental group

Treatment:

Drug: Spironolactone

Drug: CLP

CLP without spironolactone

Experimental group

Treatment:

Drug: CLP