Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Reduced Ejection Fraction

This research is looking at a new medication called Tovinontrine for individuals living with chronic heart failure where their heart's pumping ability is reduced. It's a 'Phase 2' study, meaning researchers are carefully checking if the new medicine is safe and if it shows promise in improving heart health. Participants will take either Tovinontrine (at different doses) or a dummy pill (placebo) for 12 weeks. The main goal is to see how the medicine affects a specific blood marker related to heart strain. The study is 'double-blind,' so neither the patients nor their doctors will know who is getting the active medicine and who is getting the placebo, which helps ensure fair results. This is an important step in finding better treatments for heart failure.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cardurion Pharmaceuticals Inc.

Enrolment target

265

Start

14 May 2024

Heart failure (HF) with reduced ejection fraction (HFrEF)

What is this study about?

This study is investigating a new medicine called Tovinontrine for people who have a condition known as 'heart failure with reduced ejection fraction.' This simply means your heart isn’t pumping blood around your body as strongly as it should be. The 'ejection fraction' part refers to the amount of blood pumped out of your heart with each beat – when it’s reduced, it means your heart isn't working as efficiently.

Researchers are running a 'Phase 2' trial, which is an important stage in developing new medicines. At this stage, they want to find out if Tovinontrine is safe for people to take and if it shows any signs of being effective in improving heart health. They are also looking at different doses to see which might be best. The medicine is given as a tablet that releases slowly into your body.

To figure out if the medicine is working, the doctors will measure changes in a specific substance in your blood called NT-proBNP. High levels of this substance can indicate that your heart is working harder than it should. They will check how these levels change over 12 weeks, comparing different doses of Tovinontrine against a 'placebo,' which is a dummy pill with no active medicine. This helps them understand whether any improvements are due to the medicine itself. They will also look at other blood and urine markers and how you feel in general.

Key takeaways

This study is for a new medicine, Tovinontrine, for a type of heart failure.
It aims to check the safety and potential benefits of Tovinontrine in different doses.
Participants will receive Tovinontrine or a dummy pill (placebo) for 12 weeks.
Regular health checks and blood tests will be part of taking part.
It's a 'double-blind' study, meaning neither you nor your doctor will know which treatment you receive.

Who may be eligible?

To be able to join this study, you must be at least 18 years old. The study is open to both men and women.

Beyond age and sex, there will be other specific health requirements that your doctor will need to check. For example, you would need to have been diagnosed with chronic heart failure where the heart's pumping action is reduced. There might also be certain medications you can or cannot be taking, or other medical conditions that would either qualify or disqualify you from participating. These detailed criteria ensure the study is conducted safely and provides clear results for the specific patient group they are trying to help.

If you are interested, your own doctor or the study team will go through a full checklist with you to see if you meet all the necessary requirements 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 at least 18 years old?
Do you have a diagnosis of chronic heart failure where your heart's pumping action is reduced (reduced ejection fraction)?
Are you able to attend regular clinic visits for medical checks and tests?
Are you willing to take a study medicine (or placebo) regularly for 12 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of several groups. Some groups will receive different doses of the new medicine, Tovinontrine, while another group will receive a 'placebo' – a pill that looks exactly like the study medicine but contains no active drug. Neither you nor your study doctor will know which group you are in, which helps ensure the study results are fair and accurate. You will take the assigned medicine as a tablet.

The study treatment period lasts for 12 weeks. During this time, you would have several visits to the clinic for medical check-ups, blood tests, and possibly urine tests. These tests are important for the researchers to monitor your health, check for any side effects, and see how the medicine is affecting your heart. After the 12-week treatment period, there will likely be follow-up visits to check on your well-being. The study team will explain the full schedule of visits and what each involves before you make any decisions.

Potential risks and benefits

Taking part in any medical study comes with potential benefits and risks. A potential benefit of joining this study is that you would receive close medical attention and regular health monitoring from a dedicated team. You might also have access to a new experimental medicine, Tovinontrine, that is not yet available to the public and could potentially help improve your heart condition. However, there's also a chance you might receive the placebo, meaning you wouldn’t get the active drug. As with any new medicine, there are potential risks and side effects, some of which may not yet be fully known. The study team will explain all known and possible risks before you agree to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

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

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Unverified
Italy
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Unverified
Czechia
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Unverified
Germany
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Unverified
Netherlands
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Unverified
Hungary
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Unverified
Belgium
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Unverified
Spain
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Unverified
Bulgaria
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Unverified
Poland
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Unverified
Latvia
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Unverified
Slovakia
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Unverified
Lithuania

Common questions

What is 'heart failure with reduced ejection fraction'?

It means your heart muscle isn't pumping blood as strongly as it should, affecting how much blood gets around your body.

What is Tovinontrine?

It's a new medicine being tested in this study to see if it can help people with a certain type of heart failure.

What is a 'placebo'?

A placebo is a dummy pill that looks like the study medicine but contains no active drug. It helps compare the real medicine's effects.

How long does the study treatment last?

The main treatment period for taking the study medicine or placebo is 12 weeks.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your usual medical care.