Correlates and Control of Blood Pressure Variability
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low BPV Regimen.
- Who it may be relevant to
- Registry conditions: Blood Pressure Variability. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose the research is to prospectively demonstrate agreement between EHR and ambulatory blood pressure monitor (ABPM) derived blood pressure variability (BPV), as well as the feasibility of reducing BPV using a data-driven pharmacotherapeutic approach. To this end, this is a feasibility study that will make use of the Cedars-Sinai Health System including the Medical Delivery Network and the clinics of all practitioners who use the same EHR.
Detailed description
The primary research procedures are: assessment of blood pressure variability (BPV) using ABPM compared to EHR derived values; and to assess feasibility of a data driven pharmacotherapy intervention to reduce BPV among high BPV patients. As part of an option sub-study, participants may wear a single lead ECG patch to record skin sympathetic nerve activity (SKNA), which has been previously correlated with changes in blood pressure.
Interventions
- Drug Low BPV Regimen
Each the patients' physician will invite patients to complete a 48-hour ABPM, then undergo cross-titration from their current antihypertensive regimen to a low BPV regimen, consisting of Amlodipine and Indapamide. Study staff will suggest to the treating physician to initially start patients on Amlodipine 5mg daily, with uptitration to 10mg daily to a goal systolic blood pressure (SBP)\<130 mmHg. Indapamide will be suggested to be added at 1.25mg daily and increased to 2.5mg daily, as needed to
Primary outcome measures
- Change in Blood Pressure Variability [Time frame: 48 hours]
Eligibility criteria
Inclusion criteria
- Individuals 18 years old or older are included.
- Patients followed continuously at Cedars-Sinai for at least 5 years, defined as at least 1 outpatient visit with a Cedars-Sinai physician at which a blood pressure was measured each of the last 2 calendar years
- Patients with a PCP in the Cedars-Sinai Medical Group or faculty practice
- Patients on antihypertensive therapy other than a DPH-CCB or thiazide-like diuretic
- Patients in the highest decile of BPV based on extracted BP data from the EHR
Exclusion criteria
- Any records flagged "break the glass" or "research opt out."
- Pregnant or breastfeeding patients (due to guideline recommendations for specific medications for the treatment of hypertension during pregnancy and breastfeeding).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06012487 · STUDY02827