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New heart failure drug shows promise in early trial

NCT ID NCT06215586

Disease control Sponsor: Cardurion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This Phase 2 study tested the safety and effectiveness of tovinontrine, an experimental drug, compared to a placebo in 303 adults with chronic heart failure with preserved ejection fraction. The main goal was to see if tovinontrine could lower a key biomarker (NT-proBNP) in the blood over 12 weeks. The trial is now completed, and results will help determine if further testing is warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tovinontrine
What this could lead to
If successful, this could point toward a new treatment option for chronic heart failure with preserved ejection fraction, potentially improving heart function and symptoms.
What could go wrong
This is a Phase 2 trial with only 303 participants, so results are preliminary. The drug may not show significant benefit over placebo, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

303 people

The number who actually took part.

Started

Feb 2024

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Is an adult male or female patient ≥ 18 years of age * Has evidence in the medical history supporting a diagnosis of clinical HF syndrome, NYHA functional class II to III, with the duration of at least 6 months prior to the time of Screening. The HF syndrome is defined by documentation of 1 or more of the following: * At least 1 of the typical symptoms due to HF such as dyspnea and/or fatigue limiting exercise capacity; * At least 1 of the typical signs of HF such as peripheral edema, elevated jugular venous pressure, pulmonary crackles; or * Hospitalization, emergency department visit, or outpatient visit for HF requiring intravenous (IV) or subcutaneous (SQ) diuresis within the past 12 months. * Has ejection fraction (EF) \>40% and left atrial enlargement by transthoracic echocardiogram (TTE) performed and interpreted locally at the time of Screening; * Has NT-proBNP level ≥ 300 pg/mL at the time of Screening. Patients with atrial fibrillation or flutter at the time of Screening are required to have an NT proBNP level of ≥500 pg/mL at the time of Screening; * Is on stable optimized doses of guideline-directed HF therapy, per Investigator's clinical judgment, for a minimum of 4 weeks prior to the time of Screening and during the Screening Period, with no planned changes after randomization; Has had no addition of new guideline-directed HF therapy within the 3 months prior to the time of Screening or during the Screening Period; Exclusion Criteria: * Has documented EF ≥ 60% by TTE within 6 months of the time of Screening or during the Screening Period; * Has evidence of recent HF exacerbation defined by hospitalization or requirement for IV or SQ diuretics within 60 days of the time of Screening or during the Screening Period; * Has a requirement for routine, scheduled outpatient IV infusions for HF (ie, inotropes, vasodilators, or diuretics) or routinely scheduled ultrafiltration; * Has elective interventions (eg, percutaneous coronary intervention, device implantations, percutaneous structural heart disease interventions, cardiac and non-cardiac surgery) planned to occur during involvement in this study; * Has acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, or carotid angioplasty within 60 days of the time of Screening or during the Screening Period; * Has had a prior or planned orthotopic heart transplantation; * Has presence of or plan for mechanical circulatory support; Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder diastolic heart failure heart disorder heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Heart diseases Heart failure Heart failure preserved ejection fraction

Contacts and locations

Locations

  • Cardurion Investigational Site

    Dresden, 01067, Germany

  • Cardurion Investigative Site

    Birmingham, Alabama, 35233, United States

  • Cardurion Investigative Site

    Little Rock, Arkansas, 72204, United States

  • Cardurion Investigative Site

    Orange, California, 92868, United States

  • Cardurion Investigative Site

    Torrance, California, 90502, United States

  • Cardurion Investigative Site

    Van Nuys, California, 91405, United States

  • Cardurion Investigative Site

    Jacksonville, Florida, 32216, United States

  • Cardurion Investigative Site

    Miami, Florida, 33137, United States

  • Cardurion Investigative Site

    Hazel Crest, Illinois, 60429, United States

  • Cardurion Investigative Site

    Peoria, Illinois, 61636, United States

  • Cardurion Investigative Site

    Alexandria, Louisiana, 71301, United States

  • Cardurion Investigative Site

    Covington, Louisiana, 70433, United States

  • Cardurion Investigative Site

    St Louis, Missouri, 63110, United States

  • Cardurion Investigative Site

    Buffalo, New York, 14215, United States

  • Cardurion Investigative Site

    New York, New York, 10019, United States

  • Cardurion Investigative Site

    Cleveland, Ohio, 44195, United States

  • Cardurion Investigative Site

    Oklahoma City, Oklahoma, 73135, United States

  • Cardurion Investigative Site

    Portland, Oregon, 97225, United States

  • Cardurion Investigative Site

    Rapid City, South Dakota, 57701, United States

  • Cardurion Investigative Site

    Nashville, Tennessee, 37232-7601, United States

  • Cardurion Investigative Site

    Dallas, Texas, 75246, United States

  • Cardurion Investigative Site

    McKinney, Texas, 75069, United States

  • Cardurion Investigative Site

    Burlington, Vermont, 05401, United States

  • Cardurion Investigative Site

    Chermside, Australia

  • Cardurion Investigative Site

    Bruges, 8000, Belgium

  • Cardurion Investigative Site

    Sint-Niklaas, 9100, Belgium

  • Cardurion Investigative Site

    Burgas, 8008, Bulgaria

  • Cardurion Investigative Site

    Gabrovo, 5300, Bulgaria

  • Cardurion Investigative Site

    Plovdiv, 4002, Bulgaria

  • Cardurion Investigative Site

    Plovdiv, 4003, Bulgaria

  • Cardurion Investigative Site

    Rousse, 7000, Bulgaria

  • Cardurion Investigative Site

    Sofia, 1000, Bulgaria

  • Cardurion Investigative Site

    Stara Zagora, 6000, Bulgaria

  • Cardurion Investigative Site

    Cambridge, Ontario, N1R 6V6, Canada

  • Cardurion Investigative Site

    Hamilton, Ontario, L8L 2X2, Canada

  • Cardurion Investigative Site

    Chicoutimi, Quebec, G7H 7K9, Canada

  • Cardurion Investigative Site

    Montreal, Quebec, Canada

  • Cardurion Investigative Site

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Cardurion Investigative Site

    Trois-Rivières, Quebec, G8Z 3R9, Canada

  • Cardurion Investigative Site

    Hradec Králové, 500 02, Czechia

  • Cardurion Investigative Site

    Hradec Králové, 50005, Czechia

  • Cardurion Investigative Site

    Prague, 128 02, Czechia

  • Cardurion Investigative Site

    Elsterwerda, Brandenburg, 04910, Germany

  • Cardurion Investigative Site

    Papenburg, Lower Saxony, 26871, Germany

  • Cardurion Investigative Site

    Brandenburg, State of Berlin, 10787, Germany

  • Cardurion Investigative Site

    Magdeburg, 39120, Germany

  • Cardurion Investigative Site

    Balatonfüred, 8230, Hungary

  • Cardurion Investigative Site

    Budapest, H-1122, Hungary

  • Cardurion Investigative Site

    Gyöngyös, 3200, Hungary

  • Cardurion Investigative Site

    Hatvan, 3000, Hungary

  • Cardurion Investigative Site

    Orosháza, 5900, Hungary

  • Cardurion Investigative Site

    Milan, 20138, Italy

  • Cardurion Investigative Site

    Eindhoven, 5504 DL, Netherlands

  • Cardurion Investigative Site

    Groningen, 9713 AP, Netherlands

  • Cardurion Investigative Site

    Hardenberg, 7772 SE, Netherlands

  • Cardurion Investigative Site

    Sneek, 8601 ZR, Netherlands

  • Cardurion Investigative Site

    Zutphen, 7207 AE, Netherlands

  • Cardurion Investigative Site

    Dunedin, New Zealand

  • Cardurion Investigative Site

    Grodzisk Mazowiecki, 05-825, Poland

  • Cardurion Investigative Site

    Lodz, 92-213, Poland

  • Cardurion Investigative Site

    Lublin, 20-011, Poland

  • Cardurion Investigative Site

    Sopot, 81-717, Poland

  • Cardurion Investigative Site

    Torun, 87-100, Poland

  • Cardurion Investigative Site

    Warsaw, Poland

  • Cardurion Investigative Site

    Wroclaw, 50-556, Poland

  • Cardurion Investigative Site

    Wroclaw, 50-981, Poland

  • Cardurion Investigative Site

    Córdoba, 14004, Spain

  • Cardurion Investigative Site

    Málaga, 29010, Spain

  • Cardurion Investigative Site

    Santiago de Compostela, 15706, Spain

  • Cardurion Investigative Site

    Seville, 41009, Spain

  • Cardurion Investigative Site

    Valencia, 46026, Spain

  • Cardurion Investigative Site

    Kaohsiung City, Taiwan

  • Cardurion Investigative Site

    Taipei, Taiwan

  • Cardurion Investigative Site

    Taipei County, Taiwan

  • Cardurion Investigative Site

    Taoyuan, Taiwan

  • Cardurion Investigative Site

    Bridgend, CF31 1RQ, United Kingdom

  • Cardurion Investigative Site

    Chichester, PO19 6SE, United Kingdom

  • Cardurion Investigative Site

    Dundee, DD1 9SY, United Kingdom

  • Cardurion Investigative Site

    Glasgow, G81 4DY, United Kingdom

  • Cardurion Investigative Site

    Harrow, HA1 3UJ, United Kingdom

  • Cardurion Investigative Site

    Isleworth, TW7 6AF, United Kingdom

  • Cardurion Investigative Site

    London, SE5 9RS, United Kingdom

  • Cardurion Investigative Site

    London, W1T 7HA, United Kingdom

  • Cardurion Investigative Site

    Southampton, SO16 6YD, United Kingdom

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