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Estudo para avaliar a eficácia e segurança do CDR132L em pacientes com fração de ejeção do ventrículo esquerdo reduzida após infarto do miocárdio (HF-REVERT)

3 de agosto de 2026 atualizado por: Cardior Pharmaceuticals GmbH

Estudo Fase 2, Multicêntrico, Randomizado, Paralelo, de 3 braços, controlado por placebo para avaliar a eficácia e a segurança do CDR132L em pacientes com fração de ejeção do ventrículo esquerdo reduzida (≤ 45%) após infarto do miocárdio

Este é um estudo de Fase 2, multicêntrico, randomizado, paralelo, de 3 braços, controlado por placebo para avaliar a eficácia e segurança de CDR132L em pacientes com Fração de Ejeção Ventricular Esquerda (LVEF) reduzida (≤ 45%) após infarto do miocárdio (IM). Este estudo consiste em um período de triagem (a ocorrer pelo menos 3 dias após o diagnóstico de infarto do miocárdio), um período duplo-cego de 6 meses e um período de extensão de 6 meses com a visita de fim de estudo (EOS) no dia 360/mês 12 .

Duas dosagens de CDR132L serão testadas contra placebo em seus efeitos em pacientes que acabaram de sofrer um ataque cardíaco, além do tratamento padrão. O objetivo do estudo é mostrar que o CDR132L é seguro e eficaz para melhorar a insuficiência cardíaca nesses pacientes.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

294

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Ahaus, Alemanha
        • St. Marien-Krankenhaus Ahaus
      • Dresden, Alemanha
        • Herzzentrum Dresden Universitätsklinik
      • Erfurt, Alemanha
        • Helios Klinikum Erfurt
      • Göttingen, Alemanha
        • Universitätsmedizin Göttingen
      • Hanover, Alemanha
        • Medizinische Hochschule Hannover
      • Kiel, Alemanha
        • Universitatsklinikum Schleswig-Holstein
      • Ludwigshafen, Alemanha
        • Klinikum Ludwigshafen
      • Würzburg, Alemanha
        • Universitätsklinikum Würzburg
  • Espanha
      • Badalona, Espanha
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Espanha
        • Hospital de La Santa Creu i Sant Pau
      • Granada, Espanha
        • Hospital Universitario San Cecilio
      • Madrid, Espanha
        • Hospital Universitario La Paz
      • Murcia, Espanha
        • Hospital Universitario Virgen de la Arrixaca
      • Sabadell, Espanha
        • Hospital Universitario de Sabadell
      • Seville, Espanha
        • Hospital Universitario Virgen Macarena
      • Valencia, Espanha
        • Hospital Clínico Universitario de Valencia
      • Vigo, Espanha
        • Complejo Hospitalario Universitario de Vigo
  • Grécia
      • Athens, Grécia
        • "Alexandra" General Hospital of Athens
      • Athens, Grécia
        • "Attikon" General University Hospital
      • Pátrai, Grécia
        • General University Hospital of Patras "Panagia i Voitheia"
  • Holanda
      • 's-Hertogenbosch, Holanda
        • Jeroen Bosch Ziekenhuis (JBZ) (Hieronymus Bosch Hospital) - locatie Den Bosch
      • Deventer, Holanda
        • Deventer Ziekenhuis
      • Doetinchem, Holanda
        • Slingeland Ziekenhuis
      • Ede, Holanda
        • Gelderse Vallei Ziekenhuis
      • Leeuwarden, Holanda
        • Medisch Centrum Leeuwarden
      • Lelystad, Holanda
        • St. Jansdal Ziekenhuis
      • Rotterdam, Holanda
        • Erasmus University Medical Center
      • Rotterdam, Holanda
        • Ikazia Ziekenhuis
      • Sneek, Holanda
        • D & A Research B.V.
      • Zutphen, Holanda
        • Gelre Ziekenhuizen
  • Hungria
      • Budapest, Hungria
        • Semmelweis University
  • Polônia
      • Kielce, Polônia
        • Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego
      • Krakow, Polônia
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II
      • Kędzierzyn-Koźle, Polônia
        • Polsko Amerykanskie Kliniki Serca
      • Libiąż, Polônia
        • Gabinet Internistyczno-Kardiologiczny Jacek Nowak
      • Lodz, Polônia
        • NZOZ SALUS JZ Peruga
      • Lublin, Polônia
        • One wojskowy Szpital Kliniczny w Lublinie
      • Oświęcim, Polônia
        • Medicome Sp. z o.o.
      • Przemyśl, Polônia
        • Wojewodzki Szpital Im. SW. Ojca Pio W Przemyslu
      • Sopot, Polônia
        • NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog
      • Torun, Polônia
        • Wojewodzki Szpital Zespolony
      • Wałbrzych, Polônia
        • Spec.Szpital im.dr Sokolowskiego
      • Wroclaw, Polônia
        • Investigational Site
  • Reino Unido
      • Glasgow, Reino Unido
        • Queen Elizabeth University Hospital
      • High Wycombe, Reino Unido
        • Wycombe Hospital
      • London, Reino Unido
        • Richmond Pharmacology Limited
      • Middlesbrough, Reino Unido
        • South Tees Hospital NHS Foundation Trust
  • Tcheca
      • Prague, Tcheca
        • Institut klinicke a experimentalni mediciny
      • Prague, Tcheca
        • Vseobecna fakultni nemocnice v Praze

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

30 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Principais Critérios de Inclusão:

  1. Pacientes do sexo masculino ou feminino, com idade ≥ 30 a ≤ 80 anos na data de assinatura do consentimento informado, que é definido como o início do período de triagem.
  2. Infarto agudo do miocárdio (IAM) espontâneo (tipo I) com base na definição universal de IAM com randomização para ocorrer até 14 dias após o diagnóstico do evento índice.
  3. Paciente com FEVE ≤ 45% medida por ECO após diagnóstico de IM (STEMI ou NSTEMI).
  4. Paciente com eventos de IM anteriores na história podem ser incluídos.
  5. Paciente com peso corporal ≤ 120 kg.
  6. Nível de peptídeo natriurético tipo B N-terminal ≥ 125 pg/ml e < 8000 pg/ml na triagem.
  7. Paciente com STEMI/NSTEMI submetido a intervenção coronária percutânea para este evento.

Critério de exclusão:

  1. Uma mulher com potencial para engravidar (WOCBP).
  2. Paciente com IC de origem não isquêmica; por exemplo, miocardite, cardiomiopatia alcoólica.
  3. Paciente com classe IV da New York Heart Association (NYHA) na triagem ou randomização.
  4. O paciente tem qualquer intervenção cardíaca planejada (angiograma sem angioplastia é aceitável) ou qualquer outra cirurgia planejada após o Período de Triagem.
  5. O paciente tem doença cardíaca valvular grave.
  6. O paciente tem PA sistólica < 90 mmHg ou > 180 mmHg, PA diastólica < 50 mmHg ou > 110 mmHg e/ou frequência cardíaca < 50 ou > 100 batimentos/minuto na triagem ou randomização.
  7. Paciente com taxa de filtração glomerular estimada < 30 mL/min/1,73 m2 ou em diálise.
  8. Paciente com insuficiência hepática classificada como Child-Pugh B ou C.
  9. O paciente tem histórico médico de doenças que afetam a barreira hematoencefálica, por exemplo, acidente vascular cerebral nos últimos 6 meses ou esclerose múltipla.
  10. O paciente tem histórico médico de distúrbios hemorrágicos ou trombocitopenia (plaquetas < 100.000/μL).
  11. O paciente tem diabetes mal controlado, conforme determinado pelo investigador.
  12. O paciente tem história ou presença de qualquer uma das seguintes condições cardíacas: anormalidades cardíacas estruturais conhecidas além da IC, história familiar de síndrome do QT longo, síncope cardíaca ou síncope idiopática recorrente.
  13. Quaisquer anormalidades clinicamente significativas, a critério do investigador, no ritmo, condução ou morfologia do ECG em repouso que representam um risco adicional de segurança para os pacientes.
  14. Paciente com infecção ativa por "síndrome respiratória aguda grave por coronavírus 2 (SARS-CoV-2)" confirmada de acordo com as diretrizes de teste locais na triagem.
  15. O paciente não deve ser incluído no estudo se tiver recebido qualquer terapia proibida dentro de 3 meses após a triagem.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: CDR132L 5 mg
CDR132L 5 mg/kg de peso corporal intravenoso em dose única no Dia 1, Dia 29 e Dia 57
Medicamento: CDR132L
CDR132L é um oligonucleotídeo antisense sintético (ASO) e um inibidor seletivo do microRNA-132-3p (miR-132). miR-132 em cardiomiócitos é um interruptor central que afeta a expressão de genes que estão crucialmente envolvidos na remodelação cardíaca mal-adaptativa, transformação e crescimento cardíaco patológico (hipertrofia), contribuindo para remodelação cardíaca adversa e insuficiência cardíaca (IC).1-5 A expressão aberrante de miR-132 em células cardíacas está causalmente associada à remodelação cardíaca e à progressão da IC.
Experimental: CDR132L 10 mg
CDR132L 10 mg/kg de peso corporal intravenoso em dose única no Dia 1, Dia 29 e Dia 57
Medicamento: CDR132L
CDR132L é um oligonucleotídeo antisense sintético (ASO) e um inibidor seletivo do microRNA-132-3p (miR-132). miR-132 em cardiomiócitos é um interruptor central que afeta a expressão de genes que estão crucialmente envolvidos na remodelação cardíaca mal-adaptativa, transformação e crescimento cardíaco patológico (hipertrofia), contribuindo para remodelação cardíaca adversa e insuficiência cardíaca (IC).1-5 A expressão aberrante de miR-132 em células cardíacas está causalmente associada à remodelação cardíaca e à progressão da IC.
Comparador de Placebo: Placebo
Placebo intravenoso em dose única no Dia 1, Dia 29 e Dia 57
Medicamento: Placebo para CDR132L
Placebo para CDR132L

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percent Change From Baseline in LVESVI (Left Ventricular End-systolic Volume Index) at Month 6
Prazo: Baseline (Day 1), Month 6
Percent change from baseline in LVESVI at Month 6 is presented. LVESVI is considered one of the standard echocardiography (ECHO) markers for assessing risks in ischemic heart failure (HF). The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 6

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Treatment Emergent Adverse Events (TEAEs)
Prazo: Up to 12 months
Number of TEAEs were presented. TEAEs were defined as AEs that first occurred or worsened in severity after the first administration of study treatment and prior to 30 days after the last administration of study treatment.
Up to 12 months
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Prazo: Up to 12 months
Number of TESAEs are presented. TEAEs were defined as AEs that first occurred or worsened in severity after the first administration of study treatment and prior to 30 days after the last administration of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent disability/incapacity, e) is a congenital anomaly/birth defect, f) other situations where medical or scientific judgement should be excercised.
Up to 12 months
Number of Participants With Abnormalities in Clinically Relevant Laboratory Assessments
Prazo: At month 6
Number of participants with abnormalities in clinically relevant laboratory assessments up to month 6 is presented. Laboratory investigation included hematology, chemistry, coagulation and urinalysis parameters. Clinical relevance was decided by the investigator.
At month 6
Number of Participants With Clinically Relevant Laboratory Abnormalities in Vital Signs Parameters
Prazo: At month 12
Number of participants with clinically relevant laboratory abnormalities in vital signs parameters on month 12 is presented. Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. Clinical relevance was decided by the investigator.
At month 12
Number of Participants With Clinically Relevant Laboratory Abnormalities in ECG Parameters
Prazo: At month 12
Number of participants with clinically relevant laboratory abnormalities in ECG parameters at month 12 is presented. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Pulse Rate, QRS, QT interval. Clinical relevance was decided by the investigator.
At month 12
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 3
Prazo: Baseline (Day 1), Month 3
Absolute change from baseline in LVEF at month 3 is presented. LVEF is an established method for evaluation of left ventricular systolic function. A 2D echocardiography (ECHO) was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Baseline (Day 1), Month 3
Absolute Change From Baseline in LVEF at Month 6
Prazo: Baseline (Day 1), Month 6
Absolute change from baseline in LVEF at month 6 is reported. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Baseline (Day 1), Month 6
Absolute Change From Baseline in LVEF at Month 12
Prazo: Baseline (Day 1), Month 12
Absolute change from baseline in LVEF at month 12 is reported. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Baseline (Day 1), Month 12
Relative Change From Baseline in LVEF at Month 3
Prazo: Baseline (Day 1), Month 3
Relative change from baseline in LVEF at month 3 is presented. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Baseline (Day 1), Month 3
Relative Change From Baseline in LVEF at Month 6
Prazo: Baseline (Day 1), Month 6
Relative change from baseline in LVEF at month 6 is presented. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Baseline (Day 1), Month 6
Relative Change From Baseline in LVEF at Month 12
Prazo: Baseline (Day 1), Month 12
Relative change from baseline in LVEF at month 12 is presented. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Baseline (Day 1), Month 12
Absolute Change From Baseline in LVESVI at Month 3
Prazo: Baseline (Day 1), Month 3
Absolute change from baseline in LVESVI at month 3 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 3
Absolute Change From Baseline in LVESVI at Month 6
Prazo: Baseline (Day 1), Month 6
Absolute change from baseline in LVESVI at month 6 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 6
Absolute Change From Baseline in LVESVI at Month 12
Prazo: Baseline (Day 1), Month 12
Absolute change from baseline in LVESVI at month 12 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 12
Relative Change From Baseline in LVESVI at Month 3
Prazo: Baseline (Day 1), Month 3
Relative change from baseline in LVESVI at month 3 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 3
Relative Change From Baseline in LVESVI at Month 12
Prazo: Baseline (Day 1), Month 12
Relative change from baseline in LVESVI at month 12 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 12
Absolute Change From Baseline in Troponin T at Month 3
Prazo: Baseline (Day 1), Month 3
Absolute change from baseline in troponin T at month 3 is presented. Troponin T levels were measured by high-sensitivity cardiac troponin (hs-cTn) assays.
Baseline (Day 1), Month 3
Absolute Change From Baseline in Troponin T at Month 6
Prazo: Baseline (Day 1), Month 6
Absolute change from baseline in troponin T at month 6 is presented. Troponin T levels were measured by hs-cTn assays.
Baseline (Day 1), Month 6
Absolute Change From Baseline in Troponin T at Month 12
Prazo: Baseline (Day 1), Month 12
Absolute change from baseline in troponin T at month 12 is presented. Troponin T levels were measured by hs-cTn assays.
Baseline (Day 1), Month 12
Relative Change From Baseline in Troponin T at Month 3
Prazo: Baseline (Day 1), Month 3
Relative change from baseline in troponin T at month 3 is presented. Troponin T levels were measured by hs-cTn assays.
Baseline (Day 1), Month 3
Relative Change From Baseline in Troponin T at Month 6
Prazo: Baseline (Day 1), Month 6
Relative change from baseline in troponin T at month 6 is presented. Troponin T levels were measured by hs-cTn assays.
Baseline (Day 1), Month 6
Relative Change From Baseline in Troponin T at Month 12
Prazo: Baseline (Day 1), Month 12
Relative change from baseline in troponin T at month 12 is presented. Troponin T levels were measured by hs-cTn assays.
Baseline (Day 1), Month 12
Absolute Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Month 1
Prazo: Baseline (Day 1), Month 1
Absolute change from baseline in NT-proBNP at month 1 is presented.
Baseline (Day 1), Month 1
Absolute Change From Baseline in NT-proBNP at Month 2
Prazo: Baseline (Day 1), Month 2
Absolute change from baseline in NT-proBNP at month 2 is presented.
Baseline (Day 1), Month 2
Absolute Change From Baseline in NT-proBNP at Month 3
Prazo: Baseline (Day 1), Month 3
Absolute change from baseline in NT-proBNP at month 3 is presented.
Baseline (Day 1), Month 3
Absolute Change From Baseline in NT-proBNP at Month 6
Prazo: Baseline (Day 1), Month 6
Absolute change from baseline in NT-proBNP at month 6 is presented.
Baseline (Day 1), Month 6
Absolute Change From Baseline in NT-proBNP at Month 12
Prazo: Baseline (Day 1), Month 12
Absolute change from baseline in NT-proBNP at month 12 is presented.
Baseline (Day 1), Month 12
Relative Change From Baseline in NT-proBNP at Month 1
Prazo: Baseline (Day 1), Month 1
Relative change from baseline in NT-proBNP at month 1 is presented.
Baseline (Day 1), Month 1
Relative Change From Baseline in NT-proBNP at Month 2
Prazo: Baseline (Day 1), Month 2
Relative change from baseline in NT-proBNP at month 2 is presented.
Baseline (Day 1), Month 2
Relative Change From Baseline in NT-proBNP at Month 3
Prazo: Baseline (Day 1), Month 3
Relative change from baseline in NT-proBNP at month 3 is presented.
Baseline (Day 1), Month 3
Relative Change From Baseline in NT-proBNP at Month 6
Prazo: Baseline (Day 1), Month 6
Relative change from baseline in NT-proBNP at month 6 is presented.
Baseline (Day 1), Month 6
Relative Change From Baseline in NT-proBNP at Month 12
Prazo: Baseline (Day 1), Month 12
Relative change from baseline in NT-proBNP at month 12 is presented.
Baseline (Day 1), Month 12
Absolute Change From Baseline in Mean KCCQ Score (Overall Summary Score) at Month 6
Prazo: Baseline (Day 1), Month 6
Absolute change from baseline in mean Kansas City Cardiomyopathy Questionnaire (KCCQ) score (overall summary score) at month 6 is presented. The KCCQ is a 23-item, self-administered ques-tionnaire developed to independently measure the participant's perception of their health status. Scores range from 0 to 100, with 0 as lowest score and 100 as the highest score. Higher scores indi-cate better health status, fewer symptoms, and greater disease-specific health-related quality of life. The calculation is following the KCCQ scoring manual that states: "Overall Summary Score is defined as mean of the following available summary scores: Physical Limitation Score, Total Symptom Score, Quality of Life Score and Social Limitation Score". Because the manual states that the Overall Sum-mary Score should be calculated on available scores, then if physical limitation score is missing, but other sub scores are available the Overall Summary Score will be calculated anyhow based on other sub scores.
Baseline (Day 1), Month 6
Absolute Change From Baseline in Mean KCCQ Score (Overall Summary Score) at Month 12
Prazo: Baseline (Day 1), Month 12
Absolute change from baseline in mean KCCQ score (overall summary score) at month 12 is presented. The KCCQ is a 23-item, self-administered ques-tionnaire developed to independently measure the participant's perception of their health status. Scores range from 0 to 100, with 0 as lowest score and 100 as the highest score. Higher scores indi-cate better health status, fewer symptoms, and greater disease-specific health-related quality of life. The calculation is following the KCCQ scoring manual that states: "Overall Summary Score is defined as mean of the following available summary scores: Physical Limitation Score, Total Symptom Score, Quality of Life Score and Social Limitation Score". Because the manual states that the Overall Summary Score should be calculated on available scores, then if physical limitation score is missing, but other sub scores are available the Overall Summary Score will be calculated anyhow based on other sub scores.
Baseline (Day 1), Month 12
Absolute Change From Baseline in KCCQ Subdomain Score (Symptom Burden) at Month 6
Prazo: Baseline (Day 1), Month 6
Absolute change from baseline in KCCQ subdomain score (symptom burden) at month 6 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Symptom burden: scores on a scale of 0 to 100, higher scores means better outcome.
Baseline (Day 1), Month 6
Absolute Change From Baseline in KCCQ Subdomain Score (Symptom Burden) at Month 12
Prazo: Baseline (Day 1), Month 12
Absolute change from baseline in KCCQ subdomain score (symptom burden) at month 12 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Symptom burden: scores on a scale of 0 to 100, higher scores means better outcome.
Baseline (Day 1), Month 12
Absolute Change From Baseline in KCCQ Subdomain Score (Physical Limitation) at Month 6
Prazo: Baseline (Day 1), Month 6
Absolute change from baseline in KCCQ subdomain score (physical limitation) at month 6 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Physical limitation: scores on a scale of 0 to 100, higher scores means better outcome.
Baseline (Day 1), Month 6
Absolute Change From Baseline in KCCQ Subdomain Score (Physical Limitation) at Month 12
Prazo: Baseline (Day 1), Month 12
Absolute change from baseline in KCCQ subdomain score (physical limitation) at month 12 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Physical limitation: scores on a scale of 0 to 100, higher scores means better outcome.
Baseline (Day 1), Month 12
Absolute Change From Baseline in KCCQ Subdomain Score (Quality of Life) at Month 6
Prazo: Baseline (Day 1), Month 6
Absolute change from baseline in KCCQ subdomain score (quality of life) at month 6 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Quality of life: scores on a scale of 0 to 100, higher scores means better outcome.
Baseline (Day 1), Month 6
Absolute Change From Baseline in KCCQ Subdomain Score (Quality of Life) at Month 12
Prazo: Baseline (Day 1), Month 12
Absolute change from baseline in KCCQ subdomain score (quality of life) at month 12 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Quality of life: scores on a scale of 0 to 100, higher scores means better outcome.
Baseline (Day 1), Month 12

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Cardior Pharmaceuticals GmbH

Investigadores

  • Investigador principal: Johann Bauersachs, Prof. Dr., Hannover Medical School

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

11 de julho de 2022

Conclusão Primária (Real)

26 de setembro de 2024

Conclusão do estudo (Real)

17 de março de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

20 de abril de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de abril de 2022

Primeira postagem (Real)

28 de abril de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de agosto de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CDR132L-P2-01
  • 2023 (Concessão/Contrato do NIH dos EUA: GRAMMY Museum Foundation)
  • 2021-006040-27 (Número EudraCT)
  • 2023-507569-24-00 (Ctis)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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