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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Dietary Supplement: Lysine Chloride

• Registration Number: NCT02031354
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2013-12-12
• Study Start: 2014-01
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-09
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lysine Chloride	Lysine Chloride	-

Primary Outcome Measures

Name	Time	Method
Change in plasma renin activity following lysine chloride administration	3 days
Change in diuretic response following lysine chloride administration	3 days	Diuretic response will me evaluated by measuring volume of urine produced following diuretic administration
Change in urinary renin level following lysine chloride administration	3 days

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States