Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Safety and Effectiveness of Tovinontrine for Adults with Chronic Heart Failure with Preserved Ejection Fraction

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Tovinontrine in patients with chronic heart failure with preserved ejection fraction (HFpEF). Chronic heart failure is a condition where the heart is unable to pump blood effectively, and in this specific type, the heart's pumping ability is preserved, but it still struggles to fill properly. The study will compare the effects of Tovinontrine, a small molecule inhibitor of phosphodiesterase type 9 (PDE9), with a placebo to understand its safety and effectiveness.

The purpose of the study is to evaluate how Tovinontrine affects levels of a substance in the blood called N-terminal pro b-type natriuretic peptide (NT-proBNP), which is often elevated in heart failure. Participants will be randomly assigned to receive either Tovinontrine or a placebo. The study will last for 12 weeks, during which participants will take the medication in tablet form by mouth. Throughout the study, various health assessments will be conducted to monitor changes in NT-proBNP levels and other health indicators.

This trial aims to provide valuable information on whether Tovinontrine can be a safe and effective treatment option for individuals with HFpEF. By understanding its impact on NT-proBNP levels and other health measures, researchers hope to find new ways to manage this challenging condition.

The research process

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

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to one of two groups. One group receives the active medication, tovinontrine, while the other group receives a placebo. This process is double-blind, meaning neither the participants nor the researchers know who is receiving the active medication or the placebo.

  2. Step 2

    Medication administration

    Participants take the assigned tablet orally. The dosage and frequency are determined by the study protocol and are consistent throughout the trial. The medication is taken for a duration of 12 weeks.

  3. Step 3

    Monitoring and assessments

    Throughout the 12-week period, participants undergo regular monitoring. This includes measuring levels of NT-proBNP, a marker related to heart function, at the start and end of the study. Additional assessments include urine and plasma tests for other markers, as well as evaluations of symptoms and quality of life using specific questionnaires.

  4. Step 4

    End of treatment evaluation

    At the end of the 12-week treatment period, participants undergo a final evaluation. This includes a comprehensive assessment of heart function, symptom changes, and overall health status. The results are compared to the baseline measurements taken at the beginning of the study.

Who can join the trial?

7 criteria

  • Must be an adult, meaning 18 years of age or older.
  • Must have a medical history that shows a diagnosis of **clinical heart failure**. This is a condition where the heart doesn't pump blood as well as it should. The patient should be in **NYHA functional class II to III**, which means they have mild to moderate symptoms, for at least 6 months before the screening.
  • Must have an **ejection fraction (EF)** greater than 40%. This is a measurement of how much blood the left ventricle of the heart pumps out with each contraction. Also, the left atrium of the heart should be enlarged, as seen in a **transthoracic echocardiogram (TTE)**, which is an ultrasound of the heart.
  • Must have a **NT-proBNP level** of 300 pg/mL or higher. This is a blood test that helps to diagnose heart failure. If the patient has **atrial fibrillation** or **flutter**, which are types of irregular heartbeats, the level should be 500 pg/mL or higher.
  • Must be on stable doses of heart failure medication, as recommended by guidelines, for at least 4 weeks before screening and during the screening period, with no planned changes after joining the study.
  • Must not have started any new heart failure medication, except for diuretics, which help remove excess fluid from the body, within 3 months before screening or during the screening period.
  • Other specific criteria defined by the study protocol may also apply.

Who cannot join the trial?

8 criteria

  • Patients with other serious heart conditions that are not related to chronic heart failure.
  • Patients who have had a heart attack or stroke in the last 3 months.
  • Patients with severe kidney disease or those on dialysis.
  • Patients with severe liver disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial in the last 30 days.
  • Patients with a history of drug or alcohol abuse in the past year.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Tovinontrine is being studied for its potential to help patients with chronic heart failure with preserved ejection fraction. The trial aims to see if this medication can lower levels of a specific heart-related protein in the blood, which is often higher in people with heart failure.

What is already known about the treatment

Tovinontrine – Tovinontrine is administered orally and is currently being studied in clinical trials for its potential benefits in treating chronic heart failure with preserved ejection fraction (HFpEF). It is in the investigational stage, with ongoing research to determine its safety and effectiveness. The main therapeutic indication for tovinontrine is to manage chronic heart failure, specifically targeting patients with HFpEF. At the molecular level, tovinontrine works by influencing the levels of N-terminal pro b-type natriuretic peptide (NT-proBNP), which is a marker associated with heart failure. It is classified pharmacologically as a heart failure treatment agent.

Investigated diseases

Chronic Heart Failure – Chronic heart failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. Over time, this can lead to symptoms such as shortness of breath, fatigue, and fluid retention. The condition can be caused by various factors, including coronary artery disease, high blood pressure, and previous heart attacks. As the disease progresses, the heart's ability to function continues to decline, which can affect daily activities and quality of life. It is often categorized based on the heart's ejection fraction, with heart failure with preserved ejection fraction (HFpEF) being one type. Management focuses on improving symptoms and slowing the progression of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508737-13-00Protocol codeCRD-750-202Estimated enrolment240 patientsSponsorCardurion Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.