Phase 2
Completed N=111
Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease
Source: ClinicalTrials.gov NCT01265524 ↗Enrolled (actual)
111
Serious AEs
4.5%
Results posted
Mar 2013
Primary outcomePrimary: Change in Serum Potassium — 0.15; 0.05 mg/dl
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Potassium |
0.15; 0.05 | — |
| SECONDARY Weight Loss at Week 1 |
-0.71; 0.11 | 0.014 sig |
| SECONDARY Weight Loss at Week 2 |
-0.83; 0.29 | — |
| SECONDARY Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4 |
10; 14 | — |
| SECONDARY Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8 |
5; 12 | — |
| SECONDARY Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8 |
20; 8 | 0.0002 sig |
| SECONDARY 6MWT Distance at Week 8 |
39.3; 19.7 | 0.072 |
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
Data sourced from ClinicalTrials.gov (NCT01265524). 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.