Not recruiting

Study on Hydralazine, Isosorbide Dinitrate, and Metformin for Patients with Chronic Heart Failure and Reduced Heart Function

Fast replyRegistered drugNo placebo

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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 treatments for chronic heart failure, a condition where the heart doesn't pump blood as well as it should. The study involves two main treatments. The first treatment is a combination of two medications, Hydralazine Hydrochloride and Isosorbide Dinitrate, which are combined in a tablet called BiDil. This combination is used to help improve heart function and reduce symptoms in patients with heart failure. The second treatment involves the use of Metformin Hydrochloride, a medication commonly used to lower blood sugar levels in people with diabetes, which is being studied for its potential benefits in patients with heart failure who also have diabetes or insulin resistance.

The purpose of the study is to determine if these treatments can reduce the risk of death and hospitalizations related to heart failure. Participants in the study will be randomly assigned to receive either the active medications or a placebo. The study will be conducted over a period of time, with regular check-ups to monitor the participants' health and response to the treatment. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the active medication or the placebo, to ensure unbiased results.

Throughout the study, participants will take the medications orally in tablet form. The trial aims to provide valuable information on whether these treatments can improve outcomes for patients with chronic heart failure, particularly those with reduced heart function and additional conditions like diabetes. The study is expected to continue until 2028, allowing researchers to gather comprehensive data on the long-term effects of these treatments.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
Upon joining the study, you will be randomly assigned to one of the treatment groups. This process is done through an internet-based randomization module.
You may be allocated to receive either both treatments, only one treatment, or a placebo.
Step 2
Treatment administration
If assigned to the H-HeFT group, you will receive BiDil (hydralazine hydrochloride and isosorbide dinitrate) in tablet form. The dosage and frequency will be determined by the study protocol.
If assigned to the Met-HeFT group, you will receive Metformin Hydrochloride in tablet form. The dosage and frequency will be determined by the study protocol.
If assigned to a placebo group, you will receive a tablet that does not contain active medication.
Step 3
Monitoring and follow-up
Throughout the study, your health will be monitored regularly. This includes checking for any changes in your heart condition and overall health.
You will have scheduled visits to assess your response to the treatment and to ensure your safety.
Step 4
Completion of the study
The study is expected to continue until April 2028. Your participation will last for the duration specified in the study protocol.
At the end of the study, your health will be evaluated to determine the effects of the treatment.

Who can join the trial?

12 criteria

Patients must have chronic heart failure, which means their heart is not pumping blood as well as it should over a long period.
Patients should be in NYHA-class II, III, or IV, which are categories that describe the severity of heart failure symptoms.
The left ventricular ejection fraction (LVEF) must be 40% or less. LVEF is a measurement of how much blood the left ventricle of the heart pumps out with each contraction.
Patients should be on the best possible treatment for heart failure, including medications like ACE inhibitors, ARBs, or ARNI, and beta-blockers, unless they cannot take them for medical reasons.
If needed, a CRT device (a special pacemaker) should be implanted and used for more than 3 months.
If needed, an ICD unit (a device to prevent sudden heart problems) should be planned or already implanted.
Patients must agree to participate by giving informed consent, which means they understand the study and agree to join.
For the H-HeFT part of the study, patients must have a systolic blood pressure of at least 100 mmHg.
For the H-HeFT part, patients must have certain levels of NT-proBNP or BNP, which are substances in the blood that indicate heart stress.
For the Met-HeFT part, patients must have diabetes or be at risk for diabetes, which can include having a high blood sugar level or a high body mass index (BMI).
For the Met-HeFT part, patients must have an eGFR of at least 35 ml/min, which is a measure of kidney function.
Patients can be of any gender.

Who cannot join the trial?

4 criteria

Patients who do not have chronic heart failure with reduced LVEF (left ventricular ejection fraction) of 40% or less. LVEF is a measure of how well the heart is pumping blood.
Patients who are not on optimal treatment for heart failure. This means they are not receiving the best possible care for their condition.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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Verified sites

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Verified
Aalborg University Hospital
Aalborg, Denmark
Verified
Aarhus University Hospital
Aarhus, Denmark
Responsive
Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Hydralazine-ISDN
is a combination medication used in this trial to help patients with chronic heart failure. It is believed to reduce the risk of death and the need for hospitalization due to worsening heart failure. This medication may also help prevent urgent visits to the hospital that require intravenous therapy or other treatments for heart failure.
Metformin
is a medication commonly used to manage diabetes, but in this trial, it is being tested for its potential benefits in patients with chronic heart failure. The goal is to see if Metformin can lower the chances of death and cardiovascular-related hospitalizations, such as those due to worsening heart failure, heart attacks, or strokes. It may also help reduce the need for urgent medical visits that require intensive treatments for heart failure.

What is already known about the treatment

Hydralazine-ISDN
This medication is administered orally and is currently being studied for its effects on chronic heart failure. It is primarily used to treat heart failure by reducing the incidence of death and hospitalizations related to worsening heart conditions. The mechanism of action involves the relaxation of blood vessels, which decreases the workload on the heart and improves blood flow. Hydralazine-ISDN is classified as a vasodilator, which helps to lower blood pressure and improve heart function.
Metformin
This medication is taken orally and is well-known for its use in managing diabetes. In the context of heart failure, it is being investigated for its potential to reduce death and cardiovascular hospitalizations in patients with chronic heart failure and diabetes or insulin resistance. Metformin works by improving the body's response to insulin and decreasing glucose production in the liver. It is classified as a biguanide, which helps to control blood sugar levels and may have beneficial effects on heart health.

Investigated diseases

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. It can develop over time as the heart becomes weaker or stiffer. Symptoms often include shortness of breath, fatigue, and swelling in the legs and ankles. As the condition progresses, individuals may experience difficulty performing daily activities due to reduced blood flow. The heart's reduced ability to pump can lead to fluid buildup in the lungs and other parts of the body. Over time, heart failure can lead to complications affecting other organs.