Trial · NCT07887542
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Office Systolic Blood Pressure | Baseline, month 6, month 12 | Office systolic blood pressure (mmHg) measured at the clinic visit, compared between the case-manager surveillance and passive data review conditions of the crossover design. |
| Primary | Office Diastolic Blood Pressure | Baseline, month 6, month 12 | Office diastolic blood pressure (mmHg) measured at the clinic visit, compared between the case-manager surveillance and passive data review conditions of the crossover design. |
| Primary | Home Systolic Blood Pressure | Baseline, month 6, month 12 | Mean home systolic blood pressure (mmHg), measured with the Omron HEM-7157T according to the 722 protocol: on 7 consecutive days at the start of each month, 2 sessions per day (morning and evening), 2 readings per session. Values are compared between the case-manager surveillance and passive data review conditions of the crossover design. |
| Primary | Home Diastolic Blood Pressure | Baseline, month 6, month 12 | Mean home diastolic blood pressure (mmHg) measured with the Omron HEM-7157T according to the 722 protocol (7 consecutive days at the start of each month, morning and evening, 2 readings per session), compared between the case-manager surveillance and passive data review conditions of the crossover design. |
| Primary | 24-Hour Mean Systolic Blood Pressure | Baseline, month 6, month 12 | Mean 24-hour systolic blood pressure (mmHg) on ambulatory blood pressure monitoring, compared between the case-manager surveillance and passive data review conditions of the crossover design. |
| Primary | 24-Hour Mean Diastolic Blood Pressure | Baseline, month 6, month 12 | Mean 24-hour diastolic blood pressure (mmHg) on ambulatory blood pressure monitoring, compared between the case-manager surveillance and passive data review conditions of the crossover design. |
| Secondary | Brachial-Ankle Pulse Wave Velocity | Baseline, month 6, month 12 | Brachial-ankle pulse wave velocity (m/s), measured with an automated oscillometric device, as a measure of arterial stiffness (target-organ damage). |
| Secondary | Number of Participants With Adverse Reactions Leading to Treatment Discontinuation | Up to month 12 | Participants with adverse reactions to antihypertensive treatment that led to discontinuation of a medication, recorded in the app or at clinic visits. |
| Secondary | Urine Albumin-to-Creatinine Ratio | Baseline, month 6, month 12 | Urine albumin-to-creatinine ratio (mg/g), as a measure of microalbuminuria (target-organ damage). |
| Secondary | ECG Voltage | Baseline, month 6, month 12 | Sokolow-Lyon voltage (SV1 + RV5 or RV6, mV) on 12-lead ECG, as a measure of left ventricular hypertrophy (target-organ damage). |
| Secondary | Adherence to the Home Blood Pressure Measurement Protocol | Weekly, from baseline to month 12 | Percentage of days per week on which both the morning and evening measurement sessions were completed, calculated from readings transmitted by the app. |
| Secondary | Retinal Nerve Fiber Layer Thickness | Baseline | Average retinal nerve fiber layer thickness (µm) measured by optical coherence tomography, as a measure of retinal microvascular damage. |
| Secondary | Number of Cardiology Clinic Visits | Months 0-6 and months 6-12 | Number of cardiology outpatient visits per participant, from hospital records. |
| Secondary | Number of Emergency Department Visits | Months 0-6 and months 6-12 | Number of emergency department visits per participant, from hospital records. |
| Secondary | Number of Hospital Admissions | Months 0-6 and months 6-12 | Number of hospital admissions per participant, from hospital records. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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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