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
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Lysine Chloride
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
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
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
No
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
No
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
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A Pilot Study of Dietary Chloride Supplementation on Cardiorenal Function in Heart Failure
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