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Completed

NCT Number: NCT02031354

A Pilot Study of Dietary Chloride Supplementation on Cardiorenal Function in 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lysine Chloride

Dietary Supplement

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

Primary outcomes

  1. Change in plasma renin activity following lysine chloride administration

    Time frame: 3 days

  2. Change in urinary renin level following lysine chloride administration

    Time frame: 3 days

  3. 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 9, 2014
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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