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Holistic Empowerment Assistance Recovery Transformation (HEART)

2026年11月3日 更新者: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.

調査の概要

研究の種類

介入

入学 (推定)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Belgrade、セルビア、11000
        • 募集
        • Institute for Cardiovascular Diseases Dedinje
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

40年~65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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).

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE)
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from Baseline in Health-Related Quality of Life Scores (SF-36)
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Change from Baseline in 6-Minute Walk Test (6MWT) Distance at 3, 6, and 12 Months
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月1日

一次修了 (推定)

2028年1月1日

研究の完了 (推定)

2028年1月1日

試験登録日

最初に提出

2026年3月23日

QC基準を満たした最初の提出物

2026年11月3日

最初の投稿 (実際)

2026年11月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月10日

QC基準を満たした最後の更新が送信されました

2026年11月3日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IKVBD-HEART

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いいえ

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