Back to results

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

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lysine Chloride

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Lysine Chloride

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale New Haven Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lysine Chloride

Arm Description

Outcomes

Primary Outcome Measures

Change in plasma renin activity following lysine chloride administration

Change in urinary renin level following lysine chloride administration

Change in diuretic response following lysine chloride administration

Diuretic response will me evaluated by measuring volume of urine produced following diuretic administration

Secondary Outcome Measures

Full Information

NCT ID

NCT02031354

First Posted

December 12, 2013

Last Updated

June 25, 2018

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT02031354

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Lysine Chloride

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lysine Chloride

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Lysine Chloride

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in plasma renin activity following lysine chloride administration

Time Frame

3 days

Title

Change in urinary renin level following lysine chloride administration

Time Frame

3 days

Title

Change in diuretic response following lysine chloride administration

Description

Diuretic response will me evaluated by measuring volume of urine produced following diuretic administration

Time Frame

3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey M Testani, MD/MTR

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale New Haven Hospital

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12660669

Citation

Licata G, Di Pasquale P, Parrinello G, Cardinale A, Scandurra A, Follone G, Argano C, Tuttolomondo A, Paterna S. Effects of high-dose furosemide and small-volume hypertonic saline solution infusion in comparison with a high dose of furosemide as bolus in refractory congestive heart failure: long-term effects. Am Heart J. 2003 Mar;145(3):459-66. doi: 10.1067/mhj.2003.166.

Results Reference

background

PubMed Identifier

31796

Citation

Kirchner KA, Kotchen TA, Galla JH, Luke RG. Importance of chloride for acute inhibition of renin by sodium chloride. Am J Physiol. 1978 Nov;235(5):F444-50. doi: 10.1152/ajprenal.1978.235.5.F444.

Results Reference

background

PubMed Identifier

14439868

Citation

RUBIN AL, SPRITZ N, MEAD AW, HERRMANN RA, BRAVEMAN WS, LUCKEY EH. The use of L-lysine monomydrochloride in combination with mercurial diuretics in the treatment of refractory fluid retention. Circulation. 1960 Mar;21:332-6. doi: 10.1161/01.cir.21.3.332. No abstract available.

Results Reference

background

PubMed Identifier

27507113

Citation

Hanberg JS, Rao V, Ter Maaten JM, Laur O, Brisco MA, Perry Wilson F, Grodin JL, Assefa M, Samuel Broughton J, Planavsky NJ, Ahmad T, Bellumkonda L, Tang WH, Parikh CR, Testani JM. Hypochloremia and Diuretic Resistance in Heart Failure: Mechanistic Insights. Circ Heart Fail. 2016 Aug;9(8):10.1161/CIRCHEARTFAILURE.116.003180 e003180. doi: 10.1161/CIRCHEARTFAILURE.116.003180.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs