Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
468
Countries
1
Sites
13
Heart failure with preserved ejection fraction
Assessment of the number of events resulting from heart failure exacerbation or cardiovascular death.
Key facts
- Sponsor
- Medical University Of Gdansk
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 20 Feb 2025 → 21 Nov 2025
- Decision date (initial)
- 2024-01-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Medical Research Agency (PL. Agencja Badań Medycznych)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Assessment of the number of events resulting from heart failure exacerbation or cardiovascular death.
Secondary objectives 1
- Assessment of time to hospitalization for cardiovascular reasons; Assessment of the number of events due to any cause; Assessment of time to death from any cause; Assessment of time to death from cardiovascular causes; Assessment of the quality of life using the EQ-5D test; Assessment of symptoms of heart failure and angina; Assessment of endothelial function, inflammation and heart failure based on biomarkers; Assessment of endothelial function (FMD) and microcirculation (LSCI); Evaluation of the systolic and diastolic function of the heart based on echocardiography
Conditions and MedDRA coding
Heart failure with preserved ejection fraction
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10008908 | Chronic heart failure | 10007541 |
| 20.1 | LLT | 10076396 | Heart failure with preserved ejection fraction | 10007541 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Expressing willingness to participate in the study and after obtaining information about the study, signing the informed consent form for participation in the clinical study. 2. Age at study entry ≥55 years and ≤85 years; 3. NYHA Class I to III at last screening assessment. 4. Documented diagnosis of HFpEF or new diagnosis of HFpEF based on HFA-PEFF score ≥ 5 by a cardiologist during the screening phase. 5. LVEF ≥ 50% on echocardiographic screening. 6. No modification of pharmacotherapy for at least 3 months prior to screening
Exclusion criteria 1
- 1. Current treatment in another clinical trial. 2. Hypersensitivity to trimetazidine. 3. Symptoms of parkinsonism. 4. Unavailability for all visits. 5. ≥3 class in CCS scale 6. Revascularization or venous thromboembolism within 3 months prior to the screening visit. 7. Hemodynamically significant valvular disease, hypertrophic cardiomyopathy, myocarditis and pericarditis, congenital heart disease, cardiac amyloidosis. 8. Severe ventricular arrhythmias. 9. Uncontrolled BP: SBP >170 or <85 mmHg or DBP >100 mmHg at screening or randomization visit; 10. Resting heart rate (HR) >110/min or <50/min; 11. Chronic kidney disease with eGFR <30 mL/min. 12. Blood total bilirubin ≥2 times the upper limit of normal (ULN) or ALAT or AST ≥3 times the (ULN). 13. Patient life expectancy <2 years. 14. Diagnosed malignant neoplasm within 5 years prior to screening or active cancer disease. 15. Organ transplant recipient. 16. Alcoholism. 17. Active infection as assessed by the investigator 18. Severe dysfunction of the musculoskeletal system. 19. Blood concentration of TSH or fT4 exceeding by 50% the upper and/or lower limit of the reference range. 20. Taking any drugs related to the treatment of Parkinson's disease, i.e. levodopa, dopamine agonists, anticholinergics, MAO-B inhibitors, COMT inhibitors, amantadine within three months before screening. 21. A woman trying to get pregnant naturally or in vitro, or a woman who is menstruating unwilling to protect herself against unplanned pregnancy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to hospitalization due to heart failure exacerbation or cardiovascular death.
Secondary endpoints 1
- Time to hospitalization for cardiovascular reasons; Time to hospitalization for any reason; Time to cardiovascular death; Time to death from any cause; EQ-5D score; KCCQ-12 score, NYHA Class, CCS Class; Level of biomarkers related to endothelial function; Inflammation biomarkers levels; Level of biomarkers associated with heart failure; Endothelial function parameters (FMD); Microcirculation Function Parameters (LSCI); Left ventricular systolic function parameters (ejection fraction
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Trimeductan MR, 35 mg, tabletki o zmodyfikowanym uwalnianiu
PRD351749 · Product
- Active substance
- Trimetazidine Dihydrochloride
- Pharmaceutical form
- MODIFIED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 70 mg milligram(s)
- Max total dose
- 70 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- C01EB15 — TRIMETAZIDINE
- Marketing authorisation
- 11518
- MA holder
- PRZEDSIĘBIORSTWO FARMACEUTYCZNE LEK-AM SP. Z O.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Produkt leczniczy (z rynku) posiadający rejestrację zostanie przepakowany. Opakowanie zewnętrzne będzie identyczne jak dla placebo. Blistry z leczeniem aktywnym zostaną zabezpieczone w taki sposób aby uniemożliwić identyfikację produktu, tj. rozpoznanie przez uczestników badania klinicznego, że badany produkt leczniczy zawiera trimetazydynę a nie placebo. Do blistrów (opakowania bezpośredniego) zostanie dołączona etykieta; jak również do opakowania zewnętrznego zostanie dołączona etykieta. Opakowanie zewnętrzne (kartonik) leku zostanie wymienione na opakowanie bez nadruku (identyczne jak dla placebo). Całość procesów wytwórczych będzie prowadzona w warunkach GMP.
Placebo 1
Placebo for Trimeductan MR 35/Placebo dla Trimeductan MR 35
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Gdansk
- Sponsor organisation
- Medical University Of Gdansk
- Address
- Ul. Marii Sklodowskiej-Curie 3a
- City
- Gdansk
- Postcode
- 80-210
- Country
- Poland
Scientific contact point
- Organisation
- Medical University Of Gdansk
- Contact name
- Leszek Kalinowski
Public contact point
- Organisation
- Medical University Of Gdansk
- Contact name
- Leszek Kalinowski
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 468 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Centrum Wsparcia Badań Klinicznych, Ul. Spartanska 1, 02-637, Warsaw
Specjalistyczna Praktyka Lekarska — "NEFRON" Beata Januszko-Giergielewicz
Specjalistyczna Praktyka Lekarska, Kopernika 1, 10-580, Olsztyn
Salve Medica Sp. z o.o. S.K.
Ośrodek Badań Klinicznych Salve Medica, Ul. Szparagowa 10, 91-211, Lodz
Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji
Klinika Kardiologii, Wołoska 137, 02-507, Warszawa
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
Klinika Kardiologii i Chorób Wewnętrznych, Ul. Marii Curie Sklodowskiej 9, 85-094, Bydgoszcz
KARDIOLAB Poradnia Kardiologiczna
Poradnia Kardiologiczna, Żyrardowska 68, 82-300, Elbląg
Praktyka Lekarska - Tomasz Borkowski
Praktyka Lekarska - Tomasz Borkowski, ul. Warszawska 15/9, 87-800, Włocławek
NZOZ Centrum Medyczne Dąbrowa-Dąbrówka
Poradnia Kardiologiczna, Sojowa 22, 81-589, Gdynia
Uniwersyteckie Centrum Kliniczne
II Klinika Kardiologii i Elektroterapii Serca, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z.o.o.
Oddział Kardiologiczny, Rehabilitacji Kardiologicznej, Intensywnego Nadzoru Kardiologicznego, Hubalczyków 1, 76-200, Słupsk
Uniwersyteckie Centrum Kliniczne
Poradnia Kardiologiczna Zakład Diagnostyki Chorób Serca, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersyteckie Centrum Medycyny Morskiej I Tropikalnej
Klinika Kardiologii i Chorób Wewnętrznych, Ul. Powstania Styczniowego 9b, 81-519, Gdynia
Copernicus Podmiot Leczniczy Sp. z o.o.
Oddział Kardiologiczny, Al. Jana Pawla II 50, 80-462, Gdansk
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2025-02-20 | 2025-06-11 | 2025-11-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Trimetazydyna_Protoko_2_0 clean | 2.0 |
| Recruitment arrangements (for publication) | Recruitment Arrangements_31_08_2023 | 2.0 |
| Subject information and informed consent form (for publication) | Formularz Swiadomej Zgody-biobankowanie Trimetazydyna_2_0 clean version | 2.0 |
| Subject information and informed consent form (for publication) | Informacja dla pacjenta_ swiadoma zgoda_2_0_clean version | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | CHPL_Trimeductan_MR_35 | 1 |
| Synopsis of the protocol (for publication) | Streszczenie_protokolu_2_0 clean | 2.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-04 | Poland | Acceptable 2024-01-10
|
2024-01-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-25 | Poland | Acceptable 2025-05-21
|
2025-05-25 |