Mechanism and Effects of Manipulating Chloride Homeostasis in Stable Heart Failure

NCT03440970 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-15

No results posted yet for this study

Summary

This study is designed to investigate the quantitative effects of sodium-free chloride supplementation on electrolyte balance, volume status, and sodium avidity in stable heart failure patients in a highly controlled environment.

Conditions

  • Decompensated Heart Failure

Interventions

DRUG

Lysine Chloride

Patients will receive the study drug thrice daily for 5 days.

OTHER

Placebo

Patients will receive the placebo thrice daily for 5 days.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Yale University

    lead OTHER

Principal Investigators

  • Jeffrey M Testani, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2025-08-30
Completion
2025-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03440970 on ClinicalTrials.gov