Holistic Empowerment Assistance Recovery Transformation

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

40 years - 65 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

100 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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)

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Other measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Institute for Cardiovascular Diseases Dedinje

Study start

Jan 1, 2026 Actual

Primary completion

Jan 1, 2028 Estimated

Study completion

Jan 1, 2028 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts