Trial · NCT07912671
Registered outcomes62
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 40 of 62
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Daytime Average Heart Rate | Baseline and 12 months | Changes in mean heart rate during waking hours (daytime) recorded by 24-hour Holter monitoring. Smartwatch data will be used as a reference for consistency assessment. |
| Secondary | Nighttime Average Heart Rate | Baseline and 12 months | Changes in mean heart rate during sleeping hours (nighttime) recorded by 24-hour Holter monitoring. Smartwatch data will be used as a reference for consistency assessment. |
| Secondary | 24-hour Average Heart Rate | Baseline and 12 months | Changes in mean heart rate over the full 24-hour period recorded by Holter monitoring. Smartwatch data will be used as a reference for consistency assessment. |
| Secondary | Proportion of Participants Achieving Target Resting Heart Rate at 12 Months | 12 months | Resting heart rate is defined as the 1-minute heart rate measured after at least 5 minutes of continuous rest without apparent physical activity. Resting heart rate will be primarily assessed using 24-hour Holter monitoring performed within 1 week before the 12-month visit. Under investigator supervision in a quiet hospital setting, the start and end of the resting period will be recorded, and the mean of three consecutive 1-minute heart rate measurements obtained after 5 minutes of rest will be used. Target resting heart rate is defined as 55-65 beats per minute. The proportion of participants achieving the target range at 12 months will be compared between the two study groups. |
| Secondary | Heart Rate Deceleration Capacity (DC) | Baseline and 12 months | Change in heart rate deceleration capacity (DC) from baseline to 12 months, calculated from 24-hour Holter recordings to assess autonomic regulatory function. Changes will be compared between study groups. |
| Secondary | Heart Rate Acceleration Capacity (AC) | Baseline and 12 months | Change in heart rate acceleration capacity (AC) from baseline to 12 months, calculated from 24-hour Holter recordings to assess autonomic regulatory function. Changes will be compared between study groups. |
| Secondary | Arrhythmia and Electrophysiological Parameters | Baseline and 12 months | Changes in arrhythmia and electrophysiological parameters assessed by 24-hour Holter monitoring, including premature ventricular contractions (PVCs), PVC burden, non-sustained ventricular tachycardia (NSVT), significant bradycardia, pauses \>2 seconds, second-degree or higher atrioventricular block. |
| Secondary | Incidence of New-onset Atrial Fibrillation | 12 months | New-onset AF is defined as the absence of AF evidence on baseline 12-lead ECG and 24-hour Holter, followed by the documentation of an AF episode lasting ≥30 seconds via ECG or Holter during the follow-up period. |
| Secondary | Atrial Fibrillation Burden | Baseline and 12 months | The percentage of time in atrial fibrillation relative to the total recording time (%) derived from 24-hour Holter monitoring. Assessed at baseline and 12 months. |
| Secondary | Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline and 12 months | Changes in LDL-C levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis. |
| Secondary | Glycated Hemoglobin (HbA1c) | Baseline and 12 months | Changes in HbA1c levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis. |
| Secondary | Fasting Blood Glucose (FBG) | Baseline and 12 months | Changes in FBG levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis. |
| Secondary | Uric Acid (UA) | Baseline and 12 months | Changes in UA levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis. |
| Secondary | Homocysteine (HCY) | Baseline and 12 months | Changes in plasma homocysteine levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis. |
| Secondary | Changes in Cardiovascular Medication Use | 12 months | Changes in cardiovascular medication use, including guideline-directed therapies such as antiplatelet agents, lipid-lowering medications, β-blockers, and renin-angiotensin system inhibitors, will be assessed from baseline to 12 months. Changes in the use of each medication class will be compared between the two study groups. |
| Secondary | Medication Adherence | Baseline and 12 months | Change in medication adherence from baseline to 12 months, assessed using the Adherence to Refills and Medications Scale (ARMS). |
| Secondary | Change in EQ-5D-5L Index Value | Baseline and 12 months | The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire assesses health in five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response levels, ranging from no problems to extreme problems or inability to perform. Responses across the five dimensions define a health state, which is represented by an EQ-5D-5L index value. |
| Secondary | Change in EQ Visual Analogue Scale (EQ VAS) Score | Baseline and 12 months | The EuroQol Visual Analogue Scale (EQ VAS) is a self-rated measure of overall health status. Scores range from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Higher scores indicate better perceived health status. The change in EQ VAS score from baseline to 12 months and the between-group difference in score changes will be assessed. |
| Secondary | Patient Health Questionnaire-9 (PHQ-9) Score | Baseline and 12 months | Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report questionnaire assessing depressive symptoms over the preceding 2 weeks. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 27. Higher total scores indicate more severe depressive symptoms and a worse outcome. The change in PHQ-9 total score from baseline to 12 months and the between-group difference in score changes will be assessed. |
| Secondary | Blood Pressure Control Rate | 12 months | The proportion of participants achieving the target blood pressure control (\<130/80 mmHg) at 12 months. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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