Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Initiation of angiotensin receptor-neprilysin inhibitor (ARNi) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) in patients with heart failure with reduced ejection fraction (HFrEF): the INITIATE-HFrEF randomized open-label trial

This study, called "INITIATE-HFrEF," is investigating treatments for a type of heart failure where the heart's pumping action is weaker than normal. Researchers are comparing how well different combinations of medicines, including some commonly used for heart and kidney conditions, work and how safe they are. The main goal is to find out if starting these medicines together or in a particular way can help reduce serious problems like needing to go to hospital, or experiencing side effects such as very low blood pressure or kidney issues. The study tracks participants for six months to see which treatment leads to the fewest problems and improves their health and well-being.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

University Of Porto

Enrolment target

172

Start

12 Apr 2023

Heart failure with reduced ejection fraction

What is this study about?

This study is looking into a common and serious condition called heart failure, specifically when the heart muscle doesn't pump blood as strongly as it should (doctors call this 'heart failure with reduced ejection fraction'). If you have this condition, your body might not get enough oxygen-rich blood, which can make you feel tired or breathless.

Researchers are interested in finding the best way to use some existing medicines that are already known to help people with heart failure. They are comparing different combinations of these medicines to see if starting them together, or in a specific order, can lead to better outcomes. The aim is to understand which treatment plan is most effective at preventing problems like needing hospital care, or developing side effects like very low blood pressure or kidney problems.

The study will follow participants for six months, carefully checking how they respond to the treatment. They will look at markers of heart and kidney health, blood pressure, and how patients feel overall. This research is important because it could help doctors decide the best way to prescribe these medicines for future patients, improving their quality of life and reducing serious health issues.

Key takeaways

This study focuses on improving treatment for heart failure where the heart's pumping action is weak.
It compares different combinations of existing heart medications.
The main goal is to find the safest and most effective treatment approach.
Participants will be followed for six months to monitor their health.
This research aims to help doctors better prescribe these medicines in the future.

Who may be eligible?

To be able to join this study, you need to be at least 18 years old. Both men and women are welcome to take part.

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 heart failure with reduced ejection fraction?
Are you able to attend regular appointments for six months?
Are you willing to take the study medications as prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to take a specific combination of medicines. You'll have regular check-ups over a six-month period. These check-ups will likely involve blood tests, blood pressure measurements, and heart health checks to monitor how you're responding to the treatment and to keep an eye on any side effects. The study will track your health for six months in total.

Potential risks and benefits

Participating in research studies like this can offer potential benefits, such as receiving extra medical attention and access to potentially effective treatment strategies for your condition. However, there are also potential risks, including side effects from the medications or the inconvenience of study visits. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Portugal

Common questions

What is heart failure with reduced ejection fraction?

It's a type of heart failure where your heart muscle is weakened and doesn't pump blood around your body as strongly as it should.

What kind of medicines are being tested?

The study is looking at combinations of medicines already used for heart and kidney conditions, like empagliflozin, dapagliflozin, sacubitril, and valsartan.

How long will I be involved in the study?

The study will follow participants for a period of six months.

What does a 'primary endpoint' mean?

It's the main thing the researchers are looking for to see if the treatment is working, such as whether it reduces serious problems or side effects.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study. All study-related care and medications are provided free of charge.