CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 50 enrolled
Drug / intervention
Lysine Chloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03446651
NCT03446651Early Ph 1Completed
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Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure

Yale University·interventional·Posted Feb 27, 2018·Updated Jan 30, 2024

In Brief

A Early Phase 1 clinical trial evaluating Lysine Chloride and Placebo for Heart Failure. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedFeb 27, 2018
Enrollment StartJul 12, 2018
Primary CompletionSep 7, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 8.3 years ago

Interventions

Lysine Chloridedrug

Patients will receive 7 days of therapy using 115 mmol/day of lysine chloride. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.

Placeboother

Patients will receive 7 days of therapy using placebo. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.