- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07927751
Holistic Empowerment Assistance Recovery Transformation (HEART)
Support for Recovery and Return to Life After a Cardiovascular Event - 'E' and 'M' Cardiac Rehabilitation Program
The HEART application is designed to support the implementation of secondary prevention, as well as the second and third (lifelong) phases of cardiac rehabilitation, in a broad spectrum of patients with chronic coronary syndromes following cardiovascular events (including acute myocardial infarction, angina pectoris, and coronary interventions).
The application has been registered with the Intellectual Property Office of the Republic of Serbia, with the Institute for Cardiovascular Diseases Dedinje as the rights holder. It was developed as a Proof-of-Concept project through a collaboration between the Institute for Cardiovascular Diseases Dedinje and the World Bank. The initiation of an academic study is planned pending approval from the Institute's Ethics Committee.
Following the provision of highly specialized care in tertiary referral centers, such as the Institute for Cardiovascular Diseases Dedinje, patients are typically referred to local healthcare institutions for continued follow-up and long-term management. However, real-world data indicate that post-discharge care is often suboptimal. Patients frequently demonstrate poor adherence to prescribed therapies and inadequate control of cardiovascular risk factors, resulting in a substantial risk of rehospitalization. Notably, up to 20% of patients experience a recurrent cardiovascular event within the first year after discharge.
These gaps in care are driven by multiple factors operating at different levels: at the healthcare system level, there is a limited availability of structured secondary prevention programs; at the provider level, referral rates to cardiac rehabilitation-particularly inpatient programs-remain low; and at the patient level, barriers include limited awareness, geographical distance, financial constraints, and other socioeconomic factors.
The secondary prevention and cardiac rehabilitation program encompass a comprehensive set of interventions aimed at recovery and reintegration into daily life immediately following a cardiovascular event.
Our digital platform represents the first designed hybrid model in Serbia and the wider region, accessible to any patient with a smartphone or computer access. It provides structured support for recovery and return to everyday life in a home-based setting following a cardiovascular event. The platform promotes active patient engagement in health management and encourages continuous monitoring of activities that contribute to reducing the risk of recurrent cardiovascular events, complications, and rehospitalizations, while also enabling improvements in quality of life.
It is designed as an individualized program focused on enhancing functional capacity, patient education, and ongoing support. The platform systematically monitors the modification of cardiovascular risk factors, lifestyle changes, adherence to prescribed therapy, and the achievement of optimal and target clinical values.
The platform is designed to allow the physician, at discharge or during an outpatient visit, to enter relevant patient data, including the presence of cardiovascular risk factors, secondary prevention targets, and key information from the medical record. The patient is then provided with secure access credentials to the platform via a mobile application or web portal.
Patients will receive instructions on how to use the application, which is intended for educational purposes and is non-interventional, meaning it does not provide independent guidance on therapy modification or management of acute conditions.
Patients will be required to input data related to diet, lifestyle, physical activity, medication adherence, and laboratory test results.
Follow-up visits will be scheduled at 4-6 weeks after enrollment and subsequently as needed, depending on risk factor control, for a total follow-up period of up to one year.
The platform includes educational materials as well as guided warm-up, stretching, and cool-down exercises, promoting physical activity in accordance with the principles of the European Society of Cardiology.
Patients will also be invited to provide feedback on the application's design and functionality, including comments and suggestions, as part of a user satisfaction assessment.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ivana Burazor, MD, PhD
- Número de teléfono: +381113601700
- Correo electrónico: ivana.burazor@gmail.com
Ubicaciones de estudio
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Belgrade, Serbia, 11000
- Reclutamiento
- Institute for Cardiovascular Diseases Dedinje
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Contacto:
- Ivana Burazor, MD, PhD
- Número de teléfono: +381113601700
- Correo electrónico: ivana.burazor@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients with acute and chronic coronary syndromes
- Age between 40 and 65 years
Exclusion Criteria:
- Left ventricular ejection fraction <30%
- Significant comorbidities (e.g., impaired mobility, speech difficulties, chronic renal failure)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: VR Rehabilitation
|
The HEART application is designed to support the implementation of secondary prevention, as well as the second and third (lifelong) phases of cardiac rehabilitation, in a broad spectrum of patients with chronic coronary syndromes following cardiovascular events (including acute myocardial infarction, angina pectoris, and coronary interventions). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE)
Periodo de tiempo: Up to 12 months from enrollment
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MACE is defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for worsening cardiovascular disease. |
Up to 12 months from enrollment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Health-Related Quality of Life Scores (SF-36)
Periodo de tiempo: Baseline, 3, 6, and 12 months
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Evaluated using the 36-Item Short Form Health Survey (SF-36), reporting the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Both component scores are standardized norm-based scores ranging from 0 to 100, where higher scores indicate better health-related quality of life (better outcome). |
Baseline, 3, 6, and 12 months
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Percentage of Participants Achieving Blood Pressure Target
Periodo de tiempo: Baseline, 3, 6, and 12 months
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Proportion of participants achieving target office blood pressure (systolic < 130 mmHg and diastolic < 80 mmHg) according to European Society of Cardiology (ESC) prevention guidelines. |
Baseline, 3, 6, and 12 months
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Percentage of Participants Achieving Low-Density Lipoprotein Cholesterol (LDL-C) Target
Periodo de tiempo: Baseline, 3, 6, and 12 months
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Proportion of participants achieving target LDL-C levels according to ESC prevention guidelines. |
Baseline, 3, 6, and 12 months
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Change from Baseline in Glycated Hemoglobin (HbA1c) in Participants With Diabetes
Periodo de tiempo: Baseline, 3, 6, and 12 months
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Glycemic control measured as percentage of glycated hemoglobin (HbA1c) in participants with pre-existing diabetes. |
Baseline, 3, 6, and 12 months
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Change from Baseline in Body Mass Index (BMI)
Periodo de tiempo: Baseline, 3, 6, and 12 months
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Calculated as weight in kilograms divided by the square of height in meters. |
Baseline, 3, 6, and 12 months
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Adherence to Prescribed Physical Activity Target at 12 Months
Periodo de tiempo: 12 months
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Assessed as the proportion of participants achieving the target of at least 150 minutes of moderate-intensity physical activity per week, measured using patient activity logs. |
12 months
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Mediterranean Diet Adherence Score at 12 Months
Periodo de tiempo: Baseline and 12 months
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Evaluated using the 14-item Mediterranean Diet Adherence Screener (MEDAS). Total scores range from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet (better outcome). |
Baseline and 12 months
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Persistence With Prescribed Lifestyle Rehabilitation Program at 12 Months
Periodo de tiempo: 12 months
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Assessed as the percentage of participants who complete at least 80% of prescribed outpatient rehabilitation sessions/prescribed follow-up visits over 12 months. |
12 months
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Change from Baseline in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score
Periodo de tiempo: Baseline and 12 months
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Assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The subscale consists of 7 items scored from 0 to 3, yielding a total score range from 0 to 21. Higher scores indicate greater levels of anxiety symptoms (worse outcome). |
Baseline and 12 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in 6-Minute Walk Test (6MWT) Distance at 3, 6, and 12 Months
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months
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Assessed as the total distance walked in meters during a standardized 6-minute walk test. |
Baseline, 3 months, 6 months, and 12 months
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Change from Baseline in Exercise Capacity at 3, 6, and 12 Months
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months
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Assessed in Metabolic Equivalents of Task (METs) during symptom-limited exercise testing. |
Baseline, 3 months, 6 months, and 12 months
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Change from Baseline in Peak Oxygen Uptake (VO₂ peak) at 3, 6, and 12 Months
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months
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Assessed via cardiopulmonary exercise testing (CPET) and expressed in milliliters per kilogram per minute (mL/kg/min). |
Baseline, 3 months, 6 months, and 12 months
|
Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- IKVBD-HEART
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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