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

1

What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Centro Cardiologico Monzino S.p.A. Milan Italy
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw Poland
Vitaz Sint-Niklaas Belgium
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Maxima Medisch Centrum Veldhoven The Netherlands
D & A Research B.V. Sneek The Netherlands
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun Poland
BKS Research Kft. Hatvan Hungary
Saxenburgh Medisch Centrum Hardenberg The Netherlands
Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II Grodzisk Mazowiecki Poland
Medical Center Zara-Med EOOD Stara Zagora Bulgaria
Edumed s.r.o. Nachod Czechia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Medical Center Doctor Staykov EOOD Burgas Bulgaria
Hospital Universitario Virgen Macarena Sevilla Spain
Hospital Universitario Reina Sofía Cordoba Spain
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Semmelweis University Budapest Hungary
Universidade De Santiago De Compostela Santiago De Compostela Spain
Cardiomobile Kft. Balatonfured Hungary
Klinische Forschung Berlin GbR Berlin Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH Elsterwerda Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Staedtisches Klinikum Dresden Dresden Germany
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Medical Center Teodora EOOD Ruse Bulgaria
Medical Center for Specialized Care for Cardiovascular Diseases EAD Sofia Bulgaria
Hospital Universitario Virgen De La Victoria Malaga Spain
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
DermaMed Research Kft. Oroshaza Hungary
Gelre Ziekenhuis Zutphen Zutphen The Netherlands
Cxhpmdrej Ukxzvmoacmnqty Swdycoxfl Woluwe-Saint-Lambert Belgium
Mefdhlc Cjaamv Nfj Ppxcwpboaw Gnodaec Lqtu Gabrovo Bulgaria
Ucuzaiziolvt Myxoohg Ctyxaea Gbeuzqkvb Groningen The Netherlands
Wnzwlnreupf Wahinbzkvsrdpujmgmzx Clnxgma Ocmgmndxa I Tigqhdwlxuqnt Ia Mbjwzsrskyh W Lzwky Lodz Poland
Dgyqwrjxmoma Ctcmrcv Clrdey Sxxpf Izi Pszgz Zthpjwkhz Rugfkm Mxdsrpc Ske z ocdj Wroclaw Poland
Mzerhboedvwm Hescgcrv Ftx Apjtvz Trtfsvhlc Mnmxbjw Czihael Synlz Izwp Rlfggx Erjq Plovdiv Bulgaria
Dnn modz Axxoclf Wbzljw Dsr mfzy Akemsq Mfduniqis udj Dauupvq Ldudf Drabxovr Fijzbolcta Ikdzfb Mxeakuh ukv Kjyvvcfpval Ptpenlnuprkoy Papenburg Germany
Agaanws Ojiphcmviic Prsp Gmwqkjif Xfriu Bergamo Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.05.2024
Bulgaria Bulgaria
Not recruiting
01.05.2024
Czechia Czechia
Not recruiting
01.05.2024
Germany Germany
Not recruiting
01.05.2024
Hungary Hungary
Not recruiting
01.05.2024
Italy Italy
Not recruiting
01.05.2024
Poland Poland
Not recruiting
01.05.2024
Spain Spain
Not recruiting
01.05.2024
The Netherlands The Netherlands
Not recruiting
01.05.2024

Trial locations

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.

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 ID:
2023-508737-13-00
Protocol code:
CRD-750-202
NCT ID:
NCT06215586
Trial Phase:
Therapeutic exploratory (Phase II)

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