- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ivana Burazor, MD, PhD
- Numéro de téléphone: +381113601700
- E-mail: ivana.burazor@gmail.com
Lieux d'étude
-
-
-
Belgrade, Serbie, 11000
- Recrutement
- Institute for Cardiovascular Diseases Dedinje
-
Contact:
- Ivana Burazor, MD, PhD
- Numéro de téléphone: +381113601700
- E-mail: ivana.burazor@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE)
Délai: Up to 12 months from enrollment
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in Health-Related Quality of Life Scores (SF-36)
Délai: Baseline, 3, 6, and 12 months
|
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
|
|
Percentage of Participants Achieving Blood Pressure Target
Délai: Baseline, 3, 6, and 12 months
|
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
|
|
Percentage of Participants Achieving Low-Density Lipoprotein Cholesterol (LDL-C) Target
Délai: Baseline, 3, 6, and 12 months
|
Proportion of participants achieving target LDL-C levels according to ESC prevention guidelines. |
Baseline, 3, 6, and 12 months
|
|
Change from Baseline in Glycated Hemoglobin (HbA1c) in Participants With Diabetes
Délai: Baseline, 3, 6, and 12 months
|
Glycemic control measured as percentage of glycated hemoglobin (HbA1c) in participants with pre-existing diabetes. |
Baseline, 3, 6, and 12 months
|
|
Change from Baseline in Body Mass Index (BMI)
Délai: Baseline, 3, 6, and 12 months
|
Calculated as weight in kilograms divided by the square of height in meters. |
Baseline, 3, 6, and 12 months
|
|
Adherence to Prescribed Physical Activity Target at 12 Months
Délai: 12 months
|
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
|
|
Mediterranean Diet Adherence Score at 12 Months
Délai: Baseline and 12 months
|
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
|
|
Persistence With Prescribed Lifestyle Rehabilitation Program at 12 Months
Délai: 12 months
|
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
|
|
Change from Baseline in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score
Délai: Baseline and 12 months
|
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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in 6-Minute Walk Test (6MWT) Distance at 3, 6, and 12 Months
Délai: Baseline, 3 months, 6 months, and 12 months
|
Assessed as the total distance walked in meters during a standardized 6-minute walk test. |
Baseline, 3 months, 6 months, and 12 months
|
|
Change from Baseline in Exercise Capacity at 3, 6, and 12 Months
Délai: Baseline, 3 months, 6 months, and 12 months
|
Assessed in Metabolic Equivalents of Task (METs) during symptom-limited exercise testing. |
Baseline, 3 months, 6 months, and 12 months
|
|
Change from Baseline in Peak Oxygen Uptake (VO₂ peak) at 3, 6, and 12 Months
Délai: Baseline, 3 months, 6 months, and 12 months
|
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
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- IKVBD-HEART
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .