Heart FailureNCT02031354
A Pilot Study of Dietary Chloride Supplementation on Cardiorenal Function in Heart Failure
A study testing Lysine Chloride in people with Heart Failure, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Lysine Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06511
About this study
Official title: Prospective "Pre-post" Pilot Study on the Effects of Dietary Chloride Supplementation on Neurohormonal and Diuretic Function in Patients With Heart Failure
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Lysine Chloride
- Keywords
- Lysine Chloride
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lysine ChlorideDietary supplement
Administration of 21g of lysine chloride (7g three times daily) for a period of time of 3 days
| Study group | Role | What they receive |
|---|---|---|
| Lysine Chloride | Experimental | Not described Receives: Dietary Supplement: Lysine Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma renin activity following lysine chloride administration
Measured: 3 days
Change in urinary renin level following lysine chloride administration
Measured: 3 days
Change in diuretic response following lysine chloride administration
Diuretic response will me evaluated by measuring volume of urine produced following diuretic administration
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey M Testani, MD/MTR, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031354
- Sponsor's protocol ID
- 1308012508
- Status last verified
- Jun 2018
- First submitted
- 12 Dec 2013
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12660669Kirchner 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.
PubMed 31796RUBIN 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.
PubMed 14439868Hanberg 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.
PubMed 27507113
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective "Pre-post" Pilot Study on the Effects of Dietary Chloride Supplementation on Neurohormonal and Diuretic Function in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02031354
- Acronym / sponsor ID
- 1308012508
- Conditions
- Heart Failure
- Keywords
- Lysine Chloride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lysine Chloride | Experimental | Dietary Supplement: Lysine Chloride |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Unstable heart failure
- renal replacement therapy or an estimated GFR < 30 ml/min/1.73m2
- Significant bladder dysfunction
- History of hepatic failure
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lysine ChlorideAdministration of 21g of lysine chloride (7g three times daily) for a period of time of 3 days | Dietary supplement | Lysine Chloride |
Primary outcome
Change in plasma renin activity following lysine chloride administration
Time frame: 3 days
Change in urinary renin level following lysine chloride administration
Time frame: 3 days
Change in diuretic response following lysine chloride administration
Time frame: 3 days
Diuretic response will me evaluated by measuring volume of urine produced following diuretic administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Background: PubMed 12660669Licata 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.
- Background: PubMed 31796Kirchner 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.
- Background: PubMed 14439868RUBIN 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.
- Derived from this study: PubMed 27507113Hanberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey M Testani, MD/MTR principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lysine Chloride in people with Heart Failure, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma renin activity following lysine chloride administration (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02031354, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.