Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction (REPRIEVED)
REvascularisation for Heart Failure With PReserved Ejection Fraction and Ischaemia: EValuation of Efficacy and Mechanistic Description
HFpEF (heart failure with preserved ejection fraction) is a condition in which the heart muscle becomes stiff and can't pump blood properly. People living with HFpEF also often have coronary artery disease, where the blood vessels that supply the heart are narrowed or blocked.
It is not yet know whether opening these arteries with stents improves symptoms or quality of life with HFpEF. REPRIEVED is a randomised clinical trial that aims to find out if heart stents can improve quality of life for people living with heart failure with preserved ejection fraction (HFpEF) and coronary artery disease.
Researchers will compare two groups of people; those who have a stent procedure to those who have a placebo procedure. The placebo procedure feels the same as a stent procedure but does not include a stent.
350 people with HFpEF and coronary artery disease will be asked to take part. Participants will be monitored over a period of 6 months to see if and how quality of life changes.
Before the procedure, participants will be asked to complete a short health questionnaire, have a blood test, undergo an electrocardiogram (heart tracing) and scans of their heart.
On the day of the procedure, the participant will come to the hospital for an angiogram and will be randomly allocated to have either treatment with a stent or the placebo procedure without a stent. Participants will not know whether they have received heart stents. This helps researchers know that any improvements in their quality of life are not just related to how they feel about the stenting treatment.
Participants will then be contacted by a member of the research team at 3 months and 6 months after their procedure.
At 3 months, participants will complete a short health questionnaire either by phone or during a hospital visit.
At 6 months, participants will attend the hospital to complete a short health questionnaire, have blood tests, a scan of the heart (echocardiogram) and an electrocardiogram (heart tracing) to measure any changes in the heart.
Participants will be told whether they received the stent procedure or the placebo procedure.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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London, Reino Unido
- Reclutamiento
- Guy's & St Thomas' NHS Foundation Trust
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Contacto:
- Matthew Ryan
- Número de teléfono: +442071881041
- Correo electrónico: matthew.ryan@kcl.ac.uk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
1. A diagnosis of HFpEF, defined by the European Society of Cardiology (ESC) criteria, defined as:
- Symptoms of heart failure (New York Heart Association (NYHA) class II-IV) and
- Left ventricular ejection fraction ≥ 50% and
- NT-pro-BNP > 125 pg/ml in sinus rhythm or > 365 pg/ml in atrial fibrillation and
- One or more of the following objective signs of left ventricular diastolic dysfunction:
i. Invasively measured left ventricular end diastolic pressure ≥ 15 mmHg at rest or ≥ 25 mmHg on exercise (directly measured or estimated via pulmonary capillary wedge pressure) ii. Estimated pulmonary artery systolic pressure > 35mmHg or tricuspid regurgitation velocity > 2.8 m/s on echocardiography iii. Left atrial volume index > 34ml/m2 in patient in sinus rhythm or left atrial volume index > 40ml/m2 in atrial fibrillation iv. Relative left ventricular wall thickness > 0.42 v. Left ventricular mass index ≥ 95 g/m2 in females or ≥ 115 g/m2 in males vi. Mitral E/E' ratio > 9
Exclusion Criteria:
- Age <18 years
- People without capacity to provide informed consent
- PCI contraindicated or not feasible on coronary angiography or screening CTCA
- Contraindication to clopidogrel/dual antiplatelet therapy
- Recent acute myocardial infarction or coronary revascularisation (within 90 days)
- Enrolment in another interventional study which may affect study outcomes
- Severe chronic obstructive pulmonary disease (GOLD stage ≥3)
- Haemoglobin <=80 g/L
- Other cardiac diagnosis as a cause for HFpEF (hypertrophic cardiomyopathy, untreated severe left sided valvular disease, cardiac amyloidosis)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: PCI
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Participants will receive percutaneous coronary intervention (PCI) as per current standard of care.
Angioplasty and stenting will be attempted to all significant coronary stenoses as determined by the CT-FFR or FFR measurements.
Contemporary best practice including the use of intracoronary imaging is mandated.
The default approach will be to implant drug eluting stents, but drug coated balloon angioplasty is permitted in selected cases in accordance with the current evidence base and guidelines.
Operators will achieve as much revascularisation as can safely be delivered in a timeframe which maintains blinding; if incomplete revascularisation is necessary, operators will target treatment to the most haemodynamically significant lesions subtending the largest territories.
Staged procedures are not permitted.
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Comparador de placebos: Placebo PCI
Participants will undergo a placebo stent procedure that involves placement of a catheter but no actual stent.
Participants randomised to the placebo procedure will receive matching placebo clopidogrel capsules, to be taken for up to 6 months after the procedure.
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Participant will undergo a placebo PCI procedure that involves placement of a thin tube to image the blood vessel but does not involve placement of an actual stent.
Movements of the image intensifier, screen display and personnel will simulate a PCI procedure.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Quality of life measured using KCCQ-OSS
Periodo de tiempo: At 6 months
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At 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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All-cause death and hospitalisation for heart failure
Periodo de tiempo: At 6 months
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At 6 months
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Efficacy of blinding assessed using the blinding index
Periodo de tiempo: At discharge from the procedure
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The blinding index is scaled to an interval of -1 to 1, 1 being complete lack of blinding, 0 being consistent with perfect blinding and -1 indicating opposite guessing which may be related to unblinding.
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At discharge from the procedure
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Individual components of the KCCQ (including total symptom score and clinical summary score)
Periodo de tiempo: At 6 months
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At 6 months
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Health status measured using New York Heart Association (NYHA) functional class
Periodo de tiempo: At 6 months
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At 6 months
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NT-pro-BNP measured using blood test/assay
Periodo de tiempo: At 6 months
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At 6 months
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Difference in left ventricular ejection fraction (LVEF)
Periodo de tiempo: At 6 months
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At 6 months
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Difference in diastolic function (mitral E/e')
Periodo de tiempo: At 6 months
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At 6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades cardíacas
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad coronaria
- Isquemia miocardica
- Enfermedad de la arteria coronaria
- Procedimientos quirúrgicos, operativo
- Procedimientos endovasculares
- Procedimientos quirúrgicos vasculares
- Procedimientos quirúrgicos cardiovasculares
- Procedimientos quirúrgicos mínimamente invasivos
- Intervención coronaria percutánea
Otros números de identificación del estudio
- IRAS ID 330189
- NIHR159715 (Otro número de subvención/financiamiento: National Institute for Health and Care Research)
- 12843546 (Identificador de registro: ISRCTN)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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