Holistic Empowerment Assistance Recovery Transformation
NCT07927751, Not applicable, Recruiting, Institute for Cardiovascular Diseases Dedinje
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Holistic Empowerment Assistance Recovery Transformation | ClinicalTrials.gov |
| NCT number | NCT07927751 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Institute for Cardiovascular Diseases Dedinje | ClinicalTrials.gov |
| Conditions | Rehabilitation Programs, Rehabilitation After Cardiovascular Surgery, Cardiovascular Care | ClinicalTrials.gov |
| Interventions | The HEART application | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE) | 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. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Health-Related Quality of Life Scores (SF-36) | 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). | ClinicalTrials.gov |
| Secondary | Percentage of Participants Achieving Blood Pressure Target | 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. | ClinicalTrials.gov |
| Secondary | Percentage of Participants Achieving Low-Density Lipoprotein Cholesterol (LDL-C) Target | Baseline, 3, 6, and 12 months | Proportion of participants achieving target LDL-C levels according to ESC prevention guidelines. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Glycated Hemoglobin (HbA1c) in Participants With Diabetes | Baseline, 3, 6, and 12 months | Glycemic control measured as percentage of glycated hemoglobin (HbA1c) in participants with pre-existing diabetes. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Body Mass Index (BMI) | Baseline, 3, 6, and 12 months | Calculated as weight in kilograms divided by the square of height in meters. | ClinicalTrials.gov |
| Secondary | Adherence to Prescribed Physical Activity Target at 12 Months | 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. | ClinicalTrials.gov |
| Secondary | Mediterranean Diet Adherence Score at 12 Months | 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). | ClinicalTrials.gov |
| Secondary | Persistence With Prescribed Lifestyle Rehabilitation Program at 12 Months | 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. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score | 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). | ClinicalTrials.gov |
| Other | Change from Baseline in 6-Minute Walk Test (6MWT) Distance at 3, 6, and 12 Months | Baseline, 3 months, 6 months, and 12 months | Assessed as the total distance walked in meters during a standardized 6-minute walk test. | ClinicalTrials.gov |
| Other | Change from Baseline in Exercise Capacity at 3, 6, and 12 Months | Baseline, 3 months, 6 months, and 12 months | Assessed in Metabolic Equivalents of Task (METs) during symptom-limited exercise testing. | ClinicalTrials.gov |
| Other | Change from Baseline in Peak Oxygen Uptake (VO₂ peak) at 3, 6, and 12 Months | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)