ClinicalTrials.gg
RecruitingNCT07927751HEARTUpdated Nov 10, 2026

Holistic Empowerment Assistance Recovery Transformation

An interventional study of The HEART application in Rehabilitation Programs, Rehabilitation After Cardiovascular Surgery and Cardiovascular Care, sponsored by Institute for Cardiovascular Diseases Dedinje. Recruiting at 1 site in Serbia. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Institute for Cardiovascular Diseases Dedinje · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Updated Nov 10, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
40 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rehabilitation Programs
  • Rehabilitation After Cardiovascular Surgery
  • Cardiovascular Care
03

In context

Lead sponsor

Institute for Cardiovascular Diseases Dedinje is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with acute and chronic coronary syndromes
  • Age between 40 and 65 years

Exclusion criteria

Exclusion Criteria:

  • \<30%
  • Significant comorbidities (e.g., impaired mobility, speech difficulties, chronic renal failure)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    VR Rehabilitation

    Behavioral: The HEART application

Interventions

  • BehavioralThe HEART application

    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).

06

What researchers measure

Primary outcomes

  1. Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE)

    MACE is defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for worsening cardiovascular disease.

    Time frame: Up to 12 months from enrollment

Secondary outcomes

  1. Change from Baseline in Health-Related Quality of Life Scores (SF-36)

    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).

    Time frame: Baseline, 3, 6, and 12 months

  2. Percentage of Participants Achieving Blood Pressure Target

    Proportion of participants achieving target office blood pressure (systolic \< 130 mmHg and diastolic \< 80 mmHg) according to European Society of Cardiology (ESC) prevention guidelines.

    Time frame: Baseline, 3, 6, and 12 months

  3. Percentage of Participants Achieving Low-Density Lipoprotein Cholesterol (LDL-C) Target

    Proportion of participants achieving target LDL-C levels according to ESC prevention guidelines.

    Time frame: Baseline, 3, 6, and 12 months

  4. Change from Baseline in Glycated Hemoglobin (HbA1c) in Participants With Diabetes

    Glycemic control measured as percentage of glycated hemoglobin (HbA1c) in participants with pre-existing diabetes.

    Time frame: Baseline, 3, 6, and 12 months

  5. Change from Baseline in Body Mass Index (BMI)

    Calculated as weight in kilograms divided by the square of height in meters.

    Time frame: Baseline, 3, 6, and 12 months

  6. Adherence to Prescribed Physical Activity Target at 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.

    Time frame: 12 months

  7. Mediterranean Diet Adherence Score at 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).

    Time frame: Baseline and 12 months

  8. Persistence With Prescribed Lifestyle Rehabilitation Program at 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.

    Time frame: 12 months

  9. Change from Baseline in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score

    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).

    Time frame: Baseline and 12 months

Other outcomes

  1. Change from Baseline in 6-Minute Walk Test (6MWT) Distance at 3, 6, and 12 Months

    Assessed as the total distance walked in meters during a standardized 6-minute walk test.

    Time frame: Baseline, 3 months, 6 months, and 12 months

  2. Change from Baseline in Exercise Capacity at 3, 6, and 12 Months

    Assessed in Metabolic Equivalents of Task (METs) during symptom-limited exercise testing.

    Time frame: Baseline, 3 months, 6 months, and 12 months

  3. Change from Baseline in Peak Oxygen Uptake (VO₂ peak) at 3, 6, and 12 Months

    Assessed via cardiopulmonary exercise testing (CPET) and expressed in milliliters per kilogram per minute (mL/kg/min).

    Time frame: Baseline, 3 months, 6 months, and 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2026 (actual). Primary completion is estimated for Jan 2028, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2026
First posted
Nov 10, 2026
StartActual
Jan 1, 2026
Primary completionEst.
Jan 1, 2028
CompletionEst.
Jan 1, 2028
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07927751
Lead sponsor
Institute for Cardiovascular Diseases Dedinje
Responsible party
Ivana Burazor (MD, PhD, Institute for Cardiovascular Diseases Dedinje) — Principal investigator
First posted
Nov 10, 2026
Start date
Jan 1, 2026
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Nov 10, 2026

Study contacts

Ivana Burazor, MD, PhD
Contact
ivana.burazor@gmail.com
+381113601700

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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