Hydralazine-ISDN in Patients With Chronic Heart Failure - Hydralazine Heart Failure Trial (H-HeFT) Metformin in Patients with Chronic Heart Failure and Diabetes or Insulin Resistance - Metformin Heart Failure Trial (Met-HeFT) A randomized, 2 x 2 factorial designed, double-blind, placebo controlled study (DANHEART).
This research involves two related studies, H-HeFT and Met-HeFT, for people living with chronic heart failure. In H-HeFT, doctors are testing a medicine called BiDil. In Met-HeFT, they are studying Metformin in people who also have diabetes or difficulty processing sugar. Both studies aim to find out if these treatments can help prevent serious health issues like needing to go to hospital for worsening heart failure, having a heart transplant, or experiencing a heart attack or stroke. Participants will be randomly assigned to receive either the active treatment or a dummy pill (placebo) in a way that neither they nor their doctors will know which they are getting, to keep the results fair and unbiased.
At a glance
What is this study about?
Heart failure is a condition where your heart doesn't pump blood as well as it should. This can lead to symptoms like breathlessness and tiredness, and can sometimes mean you need to go to hospital. These studies are looking for better ways to manage chronic (long-term) heart failure and improve people's health and quality of life.
The H-HeFT study is investigating a medication called BiDil, which is a combination of two drugs (Hydralazine and Isosorbide Dinitrate). Researchers want to see if BiDil can reduce serious problems like needing to be hospitalised for your heart failure, or needing a heart transplant. The Met-HeFT study is focused on people with heart failure who also have diabetes or problems with how their body uses sugar. This study is testing whether a common diabetes medication called Metformin can help prevent similar serious heart-related events or other problems like heart attacks or strokes.
Both studies are designed to be very thorough and fair. Participants will be randomly given either the active study medicine or a 'dummy' pill (placebo). Neither you nor your doctors will know which one you are taking until the study is over. This is called 'double-blind' and helps make sure the results are as accurate as possible, showing whether the study medicines truly make a difference compared to no active treatment.
Key takeaways
- Studies for people with long-term heart failure.
- Investigating BiDil and Metformin as potential treatments.
- Aims to reduce serious heart-related health problems.
- Participants receive either study drug or a dummy pill.
- All health information is kept private and confidential.
Who may be eligible?
To be able to take part in these studies, you would need to be at least 18 years old. There are no upper age limits, so adults of any age can be considered.
Both men and women can participate in these studies. The specific details of your health condition, medications you are currently taking, and other factors would also be checked carefully by the study doctors to make sure the study is a good fit for you and safe for your health. For example, the Met-HeFT study is particularly for people with chronic heart failure who also have diabetes or issues with how their body handles sugar.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of chronic heart failure?
- For the Met-HeFT study: Do you also have diabetes or issues with blood sugar regulation?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you join the study, you would first have a full health check. You would then be given either the study medicine (BiDil or Metformin, depending on which study you're in) or a dummy pill (placebo). You wouldn't know which one you're getting, and neither would your doctor. You would take this medication regularly as instructed by the study team.
During the study, you would attend regular appointments at the clinic. At these visits, doctors would monitor your heart health, take blood tests, and ask you about your well-being and any symptoms you might have. They would also keep track of any hospital stays or other medical events. The study involves ongoing follow-up to see how you are doing over time. The total duration of the study would be explained to you by the research team.
Potential risks and benefits
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Common questions
What is chronic heart failure?
Chronic heart failure means your heart isn't pumping blood as effectively as it should on a long-term basis, leading to symptoms like tiredness or breathlessness.
What is a placebo?
A placebo is a 'dummy' pill or treatment that looks like the real study medicine but doesn't contain any active drug. It helps researchers compare the effects of the actual medicine fairly.
What does 'double-blind' mean?
Double-blind means that neither you nor your study doctor will know whether you are receiving the real study medicine or the placebo. This helps prevent bias in the results.
What are BiDil and Metformin?
BiDil is a combination of two blood pressure medicines. Metformin is a medicine commonly used to treat type 2 diabetes.
How long will I be in the study?
The exact duration of the study depends on the specific protocol, which the research team will explain to you and is usually several years of follow-up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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