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Lo studio clinico NCT07496372 (REVIVE-HEART) per Insufficienza cardiaca è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV) (REVIVE-HEART) Fase III 80

Non ancora in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07496372 (REVIVE-HEART) è uno studio interventistico di Fase III volto a esaminare il trattamento per Insufficienza cardiaca, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 30 aprile 2026, con l'obiettivo di raggiungere 80 partecipanti. Sotto la guida di Help Therapeutics, dovrebbe concludersi entro il 31 agosto 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV)
Descrizione dettagliata
REVIVE-HEART is a multicenter, randomized, controlled, confirmatory clinical trial evaluating patients with advanced heart failure (NYHA III-IV). Participants were assigned to receive either conventional coronary artery bypass grafting (CABG) alone or CABG combined with HiCM-188 (150 million cells). The cells were administered via myocardial injections around the infarcted area, followed by postoperative immunosuppre...Mostra di più
Titolo ufficiale

Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV)

Patologie
Insufficienza cardiaca
Altri ID dello studio
  • REVIVE-HEART
  • Liu XC
Numero NCT
NCT07496372
Data di inizio (effettiva)
2026-04-30
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2027-08-31
Arruolamento (previsto)
80
Tipo di studio
Interventistico
FASE
Fase III
Stato
Non ancora in arruolamento
Parole chiave
Advanced heart failure
HiCM188
HiCM-188
REVIVE-HEART
cardiomyocyte
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Comparatore attivoControl group
Coronary artery bypass grafting surgery
CABG surgery
Conventional coronary artery bypass grafting (CABG) surgery
SperimentaleExperimental group
Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
HiCM-188 therapy
Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
CABG surgery
Conventional coronary artery bypass grafting (CABG) surgery
Esito primario
Misure di esitoDescrizione della misuraArco temporale
6-minute walk distance (6MWD)
12 months after surgery
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
All-cause mortality and cardiovascular mortality
12 months after surgery
6MWD
6 months after surgery
Change from baseline in the NYHA classification
12 months after surgery
Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure)
12 months after surgery
Change from baseline in the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
The MLHFQ is a self-administered disease-specific outcome measure instrument for patients with heart failure (HF), comprising 21 items rated on Likert scales, representing different degrees of impact of HF on QoL. The MLHFQ scores are on a range of 0-105, in which lower scores reflect better health status.
12 months after surgery
Change from baseline in the SF-36 questionnaire
The 36-Item Short Form Survey(SF-36) is a self-administered outcome measure instrument that comprises 36 items grouped into 8 dimensions: limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of physical health problems, bodily pain, general mental health, limitations in usual role activities because of emotional problems, vitality, general health perceptions. The SF-36 scores are on a range of 0-100, in which higher scores reflect better health status.
12 months after surgery
Myocardial blood flow as assessed by SPECT
12 months after surgery
Myocardial viability as assessed by SPECT
12 months after surgery
Left ventricular ejection fraction as assessed by MRI
Left ventricular ejection fraction
12 months after surgery
Cardiac Volumes as assessed by MRI
Left ventricular end-diastolic volume index (LVEDVi), Left ventricular end-systolic volume index (LVESVi) and Stroke Volume (SV)
12 months after surgery
Scar size as assessed by MRI
12 months after surgery
Change from baseline in NT-proBNP level
12 months after surgery
Tumor markers abnormally elevated compared to baseline
12 months after surgery
Other AEs
12 months after surgery
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  1. Aged 18 to 75 years, regardless of gender;
  2. Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT);
  3. LVEF ≤ 35% as measured by cardiac MRI;
  4. Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery;
  5. Voluntary participation and signing of the informed consent form.

Patients considered for this trial must not meet any of the following criteria:

  1. Acute viral myocarditis;
  2. Acute phase of myocardial infarction (≤ 3 months);
  3. Cardiac amyloidosis;
  4. Pericarditis;
  5. Expected to undergo heart transplantation;
  6. Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test;
  7. Suffering from autoimmune diseases;
  8. Estimated glomerular filtration rate (eGFR) < 35 ml/min/1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 100 U/L;
  9. Presence of any untreated precancerous lesions or those requiring active monitoring;
  10. Occurrence of malignant tumors within 5 years prior to screening;
  11. Expected to undergo other concurrent cardiac surgeries (excluding ventricular aneurysm resection and left atrial appendage excision/ligation);
  12. Having contraindications to the use of immunosuppressants;
  13. Having contraindications to MRI;
  14. Having contraindications to CABG surgery;
  15. Females who are pregnant, lactating, or have a positive blood pregnancy test;
  16. Plans to conceive within one year;
  17. Having systemic diseases that are not effectively controlled;
  18. Other conditions deemed unsuitable for participation in this clinical trial as evaluated by the investigator.
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