Study on the Effects of Metolazone, Acetazolamide, and a Drug Combination for Patients with Chronic Heart Failure

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What is this study about?

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.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current medications.

Eligibility criteria include being between 18 and 80 years old, having chronic heart failure, and being treated with loop diuretics.

2 randomization

Participants are randomly assigned to one of two groups: the control group or the experimental group.

The control group continues with standard diuretic therapy, which includes loop diuretics and potassium-sparing diuretics.

3 experimental treatment

Participants in the experimental group receive a combination therapy that includes acetazolamide and metolazone in addition to their current diuretic regimen.

Acetazolamide is administered as a 250 mg tablet for oral use. Metolazone is provided in either 5 mg or 10 mg tablets, also for oral use. The dosage of metolazone is adjusted as needed.

4 monitoring and follow-up

Regular monitoring is conducted to assess the effects of the treatment on exercise capacity and fluid balance.

Participants are evaluated for any changes in their condition and any potential side effects of the medications.

5 completion of trial

The trial is expected to conclude by January 31, 2027.

Upon completion, data is analyzed to compare the effectiveness of the two treatment strategies in reducing re-hospitalizations and improving patient outcomes.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Centro Cardiologico Monzino S.p.A. Milan Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
21.12.2023

Trial locations

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.

Congestive Heart Failure – This condition occurs when the heart is unable to pump blood effectively, leading to a buildup of fluid in the lungs and other parts of the body. It often results from damage to the heart muscle, which can be caused by various factors such as high blood pressure or coronary artery disease. As the disease progresses, individuals may experience symptoms like shortness of breath, fatigue, and swelling in the legs and ankles. Over time, the heart’s ability to function continues to decline, making it difficult for the body to receive the oxygen and nutrients it needs. This can lead to increased difficulty in performing everyday activities and a reduced quality of life. The condition requires ongoing management to help alleviate symptoms and improve heart function.

Trial ID:
2024-519565-21-01
Protocol code:
CCM 1862
Trial Phase:
Therapeutic confirmatory (Phase III)

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