Study on the Effects of Metolazone, Acetazolamide, and a Drug Combination for Patients with Chronic Heart Failure
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of a combined diuretic therapy on patients with chronic heart failure. Chronic heart failure is a condition where the heart is unable to pump blood effectively, leading to symptoms like shortness of breath and fatigue. The study will compare two treatment strategies. One group will receive the standard treatment with loop diuretics and potassium-sparing diuretics, which are medications that help remove excess fluid from the body. The other group will receive an experimental treatment that combines these standard medications with additional drugs called acetazolamide and metolazone. Acetazolamide and metolazone are also diuretics, but they work in different ways to help the body get rid of extra fluid.
The purpose of the study is to see if the combination of these medications can improve exercise capacity, help with breathing, and maintain a healthy fluid balance in the body better than the standard treatment alone. Participants in the study will take the medications in tablet form by mouth. The study will last for a period of three months, during which participants will be monitored to see how their condition responds to the treatment. The researchers aim to evaluate if the new combination therapy can reduce the number of times patients need to be hospitalized due to heart failure.
By participating in this study, researchers hope to gather valuable information that could lead to improved treatment options for people living with chronic heart failure. The study will help determine if the new combination of medications is more effective than the current standard treatment in managing the symptoms and complications associated with this condition.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Sign a written document that shows you understand and agree to participate in the study.
- Be between the ages of 18 and 80.
- Have **chronic heart failure**, which means your heart doesn't pump blood as well as it should. This can be with either a reduced or normal ejection fraction, which is a measure of how well your heart is pumping.
- Have been discharged from the hospital after being treated for **acute heart failure**. This means your heart failure symptoms suddenly got worse. You must have had at least two episodes of this worsening in the past 12 months.
- Be currently taking **loop diuretics**, which are medications that help remove excess fluid from your body. You should be taking a dose that is the same as or higher than 40 mg of **furosemide** (or an equivalent medication) when you were admitted to the hospital.
Who cannot join the trial?
4 criteria
- Patients with **congestive heart failure** cannot participate. This is a condition where the heart doesn't pump blood as well as it should.
- Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
- Both **male** and **female** patients are eligible, but certain criteria may exclude some individuals.
- Patients who are part of a **vulnerable population** are not included. This means people who might need special protection or care.
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Trial locations
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Investigated drugs
Loop Diuretics
are medications used to help remove excess fluid from the body. They work by making the kidneys pass more urine, which helps reduce swelling and fluid buildup, especially in conditions like heart failure.
Potassium-Sparing Diuretics
are a type of diuretic that helps the body get rid of excess fluid without causing a loss of potassium. This is important because maintaining the right level of potassium is crucial for heart and muscle function.
Acetazolamide
is a medication that helps reduce fluid buildup by making the kidneys produce more urine. It is often used in combination with other diuretics to enhance their effect and help manage conditions like heart failure.
Metolazone
is a diuretic that helps the body get rid of excess fluid by increasing urine production. It is often used when other diuretics are not effective enough on their own. In this trial, it is used in a flexible dosing manner to help manage fluid levels in patients with heart failure.
What is already known about the treatment
Acetazolamide
Acetazolamide is administered orally in tablet form. It is currently being studied in clinical trials for its effects on chronic congestive heart failure. The main therapeutic indication is to assist in managing fluid retention in heart failure patients. At the molecular level, acetazolamide works by inhibiting the enzyme carbonic anhydrase, which reduces fluid buildup by increasing urine production. It is classified as a carbonic anhydrase inhibitor.
Metolazone
Metolazone is taken orally as a tablet. It is part of ongoing research to evaluate its role in treating chronic congestive heart failure. The primary therapeutic use is to help control fluid retention in heart failure. Metolazone acts by inhibiting sodium reabsorption in the kidneys, leading to increased urine output. It belongs to the class of thiazide-like diuretics.
Investigated diseases
sourced from the EU Clinical Trials Register and site verification
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