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A Pilot Study of Dietary Chloride Supplementation on Cardiorenal Function in Heart Failure

Prospective Pre-post Pilot Study on the Effects of Dietary Chloride Supplementation on Neurohormonal and Diuretic Function in Patients With Heart Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02031354
Enrollment
11
Registered
2014-01-09
Start date
2014-01-31
Completion date
2015-03-31
Last updated
2018-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Lysine Chloride

Brief summary

The purpose of this study is to determine if administration of supplemental chloride in the form of lysine chloride to patients with congestive heart failure will affect their neurohormonal profile as well as response to diuretics.

Detailed description

This prospective pilot pre-post study was designed to determine if supplementation of sodium free chloride ion as a lysine chloride to patients with heart failure could improve parameters of neurohormonal status and diuretic responsiveness. Volunteers will receive Lysine Chloride 7 grams three times daily for three days. At baseline and then again post lysine chloride patients will undergo sampling of venous blood for determination of neurohormonal parameters in addition to formal diuretic responsiveness testing.

Interventions

DIETARY_SUPPLEMENTLysine Chloride

Administration of 21g of lysine chloride (7g three times daily) for a period of time of 3 days

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years * Fluency in English * Heart failure requiring loop diuretic therapy * Loop diuretic dose ≥ 80mg/day furosemide equivalents * Stable volume status and diuretic requirement as assessed by treating physician

Exclusion criteria

* Unstable heart failure * renal replacement therapy or an estimated GFR \< 30 ml/min/1.73m2 * Significant bladder dysfunction * History of hepatic failure * Pregnancy * History of hyperinsulinemia/hyperlysinuria

Design outcomes

Primary

MeasureTime frameDescription
Change in plasma renin activity following lysine chloride administration3 days
Change in urinary renin level following lysine chloride administration3 days
Change in diuretic response following lysine chloride administration3 daysDiuretic response will me evaluated by measuring volume of urine produced following diuretic administration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026