Clinical trial NCT02031354: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Lysine Chloride
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in plasma renin activity following lysine chloride administration
timeFrame: 3 days
measure: Change in urinary renin level following lysine chloride administration
timeFrame: 3 days
measure: Change in diuretic response following lysine chloride administration
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Jeffrey M Testani, MD/MTR
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.