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Electrolyte Modulator

Ammonium Chloride for Diuretic Resistance in Heart Failure (MsDR Aim 3 Trial)

Phase 1

Recruiting

Led By Jeffrey Testani, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Absence of non-elective hospitalizations in the previous 2 months

Clinical diagnosis of heart failure

Must not have

History of flash pulmonary edema or a 'brittle' volume sensitive HF phenotype such as amyloid cardiomyopathy

Cirrhosis or known liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2 vs day 18

Summary

This trial uses a special design where participants are randomly assigned to different groups. The study is also double-blind, meaning neither the participants nor the researchers know who is receiving the real treatment or a placebo.

Who is the study for?

This trial is for adults with heart failure who have shown resistance to a common diuretic drug. They should be stable on their current heart failure treatments, not hospitalized recently, and have certain levels of sodium, potassium, and hemoglobin in their blood. People with severe kidney issues, recent acidosis or liver disease, pregnant or breastfeeding women, and those allergic to sulfonamides can't participate.

What is being tested?

The study tests if Ammonium Chloride can overcome diuretic resistance in heart failure patients compared to a placebo. Participants will receive both the test drug and placebo at different times without knowing which one they're getting (double-blind), with random assignment (randomized) in a crossover design so everyone gets both treatments.

What are the potential side effects?

Ammonium Chloride may cause side effects like changes in blood acidity levels leading to fatigue or confusion, digestive discomfort such as nausea or vomiting, electrolyte imbalances that could affect muscle function and heartbeat regularity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't been hospitalized unexpectedly in the last 2 months.

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I have been diagnosed with heart failure.

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My body's response to a specific diuretic test was normal.

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I am not planning to change my heart failure treatments during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had sudden lung swelling or a sensitive heart condition like amyloid cardiomyopathy.

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I have cirrhosis or another liver disease.

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My kidney function is very low.

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I am currently taking pimozide or thioridazine.

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I have been diagnosed with liver failure.

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I am currently taking Lithium.

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I am allergic to or cannot take thiazide diuretics.

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I am taking medication that could lead to acidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 2 vs day 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 2 vs day 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 vs day 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in urinary extracellular vesicles (uEV) pendrin/exosomal marker(CD9) with the change in distal sodium reabsorption(ADRNa), compared between the placebo and NH4Cl

Change of distal sodium reabsorption(ADRNa) between NH4Cl vs. placebo study visits

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Ammonium chlorideActive Control1 Intervention

Participants will be randomized to ammonium chloride vs placebo. On Day 0 and 1, the participant will take ammonium chloride or placebo 75 mmol twice daily. On Day 2, the participant will take ammonium chloride 150 mmol or placebo once

Group II: PlaceboPlacebo Group1 Intervention

0 / 12Eligibility criteria met