Early Phase 1
Completed N=40
Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure
Source: ClinicalTrials.gov NCT03446651 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Change in Blood Volume — -320; -447 mL — p=0.56
Summary
The purpose of this study is to understand the effects of chloride supplementation on volume-overloaded acute heart failure patients concomitantly treated with IV diuretics.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Blood Volume |
-320; -447 | 0.56 |
| SECONDARY Change in Log NTpro-BNP |
— | — |
| SECONDARY Change in Serum Creatinine |
0.00; 0.04 | 0.039 sig |
| SECONDARY Change in Cystatin C |
— | — |
| SECONDARY Change in Chloride |
0.71; -0.87 | <0.001 sig |
| SECONDARY Change in Bicarbonate |
-1.02; 0.19 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of decompensated heart failure with at least one objective sign of volume overload (rales, edema, elevated jugular venous pressure (JVP), or weight gain of at least 5 pounds)
- A projected need by the treating clinician for continued treatment with IV diuretics
- Chronic loop diuretic use
Exclusion Criteria
- Inability to commit to or comply with serial visits for treatment in the Yale Transitional Care Center (YTCC)
- History of severe metabolic or respiratory acidosis within 30 days of enrollment
- Use of metformin, acetazolamide, or any other agent that could predispose to acidosis. Patients who are on metformin may be enrolled if their metformin can be discontinued safely for the duration of the study. Any participants who have consistently elevated Blood glucose readings > 200 mg/dL while inpatient will not be enrolled.
- Serum bicarbonate level <20mmol/L
- Estimated glomerular filtration rate <20 mL/min or renal replacement therapy
- Appears unlikely, or unable to participate in the required study procedures, as assessed by the study PI or research registered nurse (RN) (ex: clinically-significant psychiatric, addictive, or neurological disease)
- Inability to give written informed consent or follow study protocol
Data sourced from ClinicalTrials.gov (NCT03446651). 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.