Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Multi-center Study Comparing CLP Versus Placebo in Heart Failure Patients With Chronic Kidney Disease

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: CLP
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CLP<br>Investigational drug: 15 g CLP per day given as capsules | Drug: CLP<br>* Oral administration<br>|
| Placebo Comparator: Placebo<br>Placebo, capsules | Drug: Placebo<br>* Oral administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Potassium | Change in serum potassium from baseline to Week 8. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss at Week 1 |  | Baseline and 1 week | 
| Weight Loss at Week 2 |  | 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. | 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. | 8 weeks | 
| Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8 |  | 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. | Baseline and 8 weeks |