Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

Sorbent Therapeutics113 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

113

Conditions

Heart Failure

Interventions

CLPDRUG

Oral administration

PlaceboDRUG

Oral administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Yerevan, Armenia

Unnamed facility

Tbilisi, Georgia

Unnamed facility

Chisinau, Moldova

Outcomes

Primary Outcomes

Change in Serum Potassium

Change in serum potassium from baseline to Week 8.

Time frame: Baseline and 8 weeks

Secondary Outcomes

Weight Loss at Week 1

Time frame: Baseline and 1 week

Weight Loss at Week 2

Time frame: Baseline and 2 weeks

Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4

The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.

Time frame: 4 weeks

Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8

The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.

Time frame: 8 weeks

Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8

Time frame: Baseline and 8 weeks

6MWT Distance at Week 8

Increase in the 6 minute walk test (6MWT) distance from baseline to Week 8. The test was performed according to the American Thoracic Society (ATS)Guidelines 2002.

Time frame: Baseline and 8 weeks

Data from ClinicalTrials.gov

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