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Holistic Empowerment Assistance Recovery Transformation (HEART)

3 novembre 2026 aggiornato da: Ivana Burazor, Institute for Cardiovascular Diseases Dedinje

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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Belgrade, Serbia, 11000
        • Reclutamento
        • Institute for Cardiovascular Diseases Dedinje
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Health-Related Quality of Life Scores (SF-36)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in 6-Minute Walk Test (6MWT) Distance at 3, 6, and 12 Months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2026

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

23 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 novembre 2026

Primo Inserito (Effettivo)

10 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • IKVBD-HEART

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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