NCT02031354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

December 12, 2013

Last Update Submit

June 25, 2018

Conditions

Heart Failure

Keywords

Lysine Chloride

Outcome Measures

Primary Outcomes (3)

  • Change in plasma renin activity following lysine chloride administration

    3 days

  • Change in urinary renin level following lysine chloride administration

    3 days

  • Change in diuretic response following lysine chloride administration

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

    3 days

Study Arms (1)

Lysine Chloride

EXPERIMENTAL
Dietary Supplement: Lysine Chloride

Interventions

Lysine ChlorideDIETARY_SUPPLEMENT

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

Lysine Chloride

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06511, United States

Location

Related Publications (4)

  • 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.

    PMID: 12660669BACKGROUND

  • 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.

    PMID: 31796BACKGROUND

  • 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.

    PMID: 14439868BACKGROUND

  • 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.

    PMID: 27507113DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jeffrey M Testani, MD/MTR

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2013

First Posted

January 9, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

US(1)