Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CLP

Investigational drug: 15 g CLP per day given as capsules

Group Type ACTIVE_COMPARATOR

CLP

Intervention Type DRUG

Oral administration

Placebo

Placebo, capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration

Interventions

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CLP

Oral administration

Intervention Type DRUG

Placebo

Oral administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No