Study of Metolazone and Acetazolamide Combination for Patients with Acute Heart Failure and Volume Overload

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What is this study about?

This study focuses on patients with acute heart failure who have excess fluid in their body and may not respond well to standard water pill treatments. The research aims to find the most effective treatment strategy using two different medications: metolazone tablets and acetazolamide injection. These medications help remove excess fluid from the body.

The study will compare these medications with inactive treatments (placebo) that look identical to the real medicines. Some patients will receive metolazone tablets while others will get inactive tablets. Similarly, some patients will receive acetazolamide injections while others will get saline injections. The treatment period lasts for 4 days during the hospital stay.

The medications being tested are types of water pills (diuretics) that work differently from standard heart failure treatments. Metolazone is taken by mouth and helps the kidneys remove more water and salt from the body. Acetazolamide is given through an injection and works by reducing fluid buildup in the body through a different mechanism.

1 Initial admission

Upon admission to the hospital with acute heart failure, your condition and eligibility for the study will be evaluated

The medical team will check for signs of congestion (fluid retention), which may include swelling in legs, fluid in abdomen, or fluid in lungs

2 Treatment assignment

You will be assigned to receive one of the following medication combinations:

Option 1: Metolazone tablets taken by mouth

Option 2: Inactive tablets that look identical to metolazone

Option 3: Acetazolamide given through injection

Option 4: Saline solution given through injection that looks identical to acetazolamide

3 Treatment period

You will receive the assigned treatment during your hospital stay

The medical team will monitor your response to treatment, including changes in fluid retention and kidney function

Your weight and fluid balance will be regularly measured

4 Hospital discharge

You will be discharged from the hospital when your condition improves

The number of days spent in the hospital will be recorded

5 Follow-up period

Your health status will be monitored for 90 days after starting the study

The medical team will track your progress, including any hospital readmissions

Your kidney function will be evaluated during this period

Who Can Join the Study?

  • Must be 18 years or older
  • Must be admitted to hospital with acute heart failure (a sudden worsening of heart failure symptoms)
  • Must show signs of diuretic resistance by meeting one of these conditions:
    • Taking water pills (loop diuretics) daily for at least 7 days before hospital admission
    • Not responding well enough to high-dose water pills in the last 24 hours (less than 500g weight loss or less than 1L fluid loss despite receiving high doses of IV furosemide)
  • Must have at least one of these signs of fluid overload:
    • Swelling in legs or feet that leaves a dent when pressed (pitting edema)
    • Fluid in the belly area (ascites)
    • Swollen neck veins (elevated jugular venous pressure)
    • Signs of fluid in the lungs seen on X-ray or ultrasound
  • Both men and women can participate

Who Cannot Join the Study?

  • Age below 18 years or above 85 years
  • Known allergy or hypersensitivity to diuretic medications
  • Severe kidney failure requiring dialysis (a medical procedure to filter blood when kidneys don’t work properly)
  • Cardiogenic shock (a condition where the heart suddenly can’t pump enough blood to meet the body’s needs)
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the past 30 days
  • Life expectancy less than 6 months due to other medical conditions
  • Severe liver disease (poor liver function affecting blood clotting and metabolism)
  • Uncontrolled high blood pressure (systolic pressure above 180 mmHg)
  • Systemic infection (infection affecting the whole body) or active infection requiring antibiotics
  • Recent heart attack or stroke (within the last 30 days)
  • Unable to provide informed consent or follow study procedures
  • History of serious allergic reactions to medications
  • Severe mental illness that could interfere with study participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bispebjerg Hospital Copenhagen Denmark

Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Roskilde University Roskilde Denmark
Hwekekzx Hfzstkqe Hvidovre Denmark
Hrhieu Hcgbhbop Herlev Denmark
Ahrcbz Upuvncanop Hbhsqayw Aarhus Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.05.2024

Trial locations

Investigated drugs:

Furosemide is a diuretic medication (water pill) commonly used to treat heart failure. It helps remove excess fluid from the body by increasing urine production. This medication is particularly important for patients with acute heart failure who have too much fluid in their body.

Chlorothiazide is another type of diuretic that works differently from furosemide. It helps the kidneys remove excess water and salt from the body. When combined with other diuretics, it can help patients who don’t respond well to a single diuretic medication.

Spironolactone is a potassium-sparing diuretic that not only removes excess fluid but also helps maintain the body’s potassium levels. This medication is particularly useful in heart failure patients as it can help protect the heart while removing excess fluid.

Torsemide is a loop diuretic similar to furosemide but with longer-lasting effects. It helps remove excess fluid from the body and can be particularly helpful for patients who don’t respond well to other diuretics.

Acute Heart Failure – A sudden onset condition where the heart cannot pump enough blood to meet the body’s needs. It occurs when the heart muscle becomes too weak or stiff to work properly, leading to fluid buildup in the lungs and other body tissues. Patients typically experience rapid breathing, fatigue, and swelling in the legs and ankles. The condition can develop quickly, often over hours or days, and frequently results in fluid overload throughout the body. Common signs include difficulty breathing, especially when lying down, and reduced ability to exercise or perform daily activities.

Trial ID:
2024-510633-17-00
NCT ID:
NCT06166654
Trial Phase:
Therapeutic confirmatory (Phase III)

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