Phase 1 Completed N=18 Randomized Treatment

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

Heart Failure

Source: ClinicalTrials.gov NCT01598740 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2013

Primary outcomePrimary: Change in Fecal Sodium Content — 635.10; 501.95 mg — p=0.0662

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Fecal Sodium Content	635.10; 501.95	0.0662
SECONDARY Change in Fecal Weight	144.7; 119.0	0.1899

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01598740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.