BridgeMD
New treatment option for Heart Failure
Official title Mechanisms of Diuretic Resistance in Heart Failure, Aim 3
ClinicalTrials.gov ID: NCT06209359
What this study is testing
What is Ammonium Chloride?
Ammonium Chloride is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Randomized double-blind placebo-controlled crossover study design
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical diagnosis of heart failure
- No plan for titration/change of heart failure medical or device therapies during the study period.
- Absence of non-elective hospitalizations in the previous 2 months.
- At optimal volume status by symptoms, exam, and dry weight.
- Serum potassium ≤ 5.0 mmol/L
You likely can't join if
- Glomerular filtration rate (GFR) \<20 ml/min/1.73m2
- Use of any non-loop type diuretic in the last 7 days with the exclusion of low dose aldosterone antagonist (e.g., spironolactone ≤50 mg)
- History of flash pulmonary edema or a "brittle" volume sensitive HF phenotype such as amyloid cardiomyopathy
- Hemoglobin \< 8 g/dL
- Pregnant or breastfeeding
- Cirrhosis or known liver disease
See the full eligibility criteria
- Clinical diagnosis of heart failure
- No plan for titration/change of heart failure medical or device therapies during the study period.
- Absence of non-elective hospitalizations in the previous 2 months.
- At optimal volume status by symptoms, exam, and dry weight.
- Serum potassium ≤ 5.0 mmol/L
- Serum sodium ≥ 130 milliequivalents/ liter (mEq/L)
- Hemoglobin ≥8 g/dL
- Age \>18 years
- Objective evidence of diuretic resistance to a 10mg bumetanide challenge (screening visit may occur under this protocol or HIC2000032328 or HIC2000034315) defined as:
- FENa \<10% and total sodium output \<150mmol
- And at least one of the following criteria:
- Chronic home furosemide dose greater than or equal to 80mg furosemide equivalents
- eGFR \< 60ml/min
- Serum chloride \<100mmol/L
- FENa \<5% and total sodium output \<75mmol on the 2 hour
- Glomerular filtration rate (GFR) \<20 ml/min/1.73m2
- Use of any non-loop type diuretic in the last 7 days with the exclusion of low dose aldosterone antagonist (e.g., spironolactone ≤50 mg)
- History of flash pulmonary edema or a "brittle" volume sensitive HF phenotype such as amyloid cardiomyopathy
- Hemoglobin \< 8 g/dL
- Pregnant or breastfeeding
- Cirrhosis or known liver disease
- History of metabolic or respiratory acidosis within 30 days
- Use of metformin, acetazolamide, or any other agent that could predispose to acidosis
- Patients who are on metformin may be enrolled if their metformin can be safely discontinued for the assigned by chance treatment periods in each arm. Any participants who have consistently elevated blood glucose...
- Serum bicarbonate level \<24mmol/L at screening visit
- Venous potential of hydrogen(pH) \<7.35 at screening visit
- Inability to give written informed consent or comply with study protocol or follow-up visits
- On Lithium therapy
- On pimozide or thioridazine
- Diagnosis of liver failure
- Contraindications or allergy to sulfonamides
- Any contraindication to thiazide diuretic or allergy to thiazide or bendroflumethiazide
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.