Correlates and Control of Blood Pressure Variability

Phase 1

Not yet recruiting

• Conditions: Blood Pressure Variability
• Interventions: Drug: Low BPV Regimen

• Registration Number: NCT06012487
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Study Start: 2026-05-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ambulatory Blood Pressure Monitor (ABPM)	Low BPV Regimen	Participants on antihypertensive pharmacotherapy in the highest decile of BPV will be offered enrollment based on inclusion/exclusion criteria. Patient's will undergo a 48 hour ABPM to determine baseline BPV. Next, each patient's primary care physician will be guided through titrations to antihypertensive medications to a low BPV regimen (Amlodipine and Indapamide, with doses titrated to reach target blood pressure). Following this, patients will undergo repeat 48h ABPM to evaluate change in BPV. All medication decisions will be at the ultimate discretion of the treating physician. The optional sub-study will test the hypothesize that ABPM and SKNA data can be simultaneously captured and that BPV will be positively correlated with SKNA. Participants who enroll in the optional sub-study will be fitted with a single patch ECG which will capture high-fidelity ECG tracings from which SKNA can be determine in post-test analysis.

Primary Outcome Measures

Name	Time	Method
Change in Blood Pressure Variability	48 hours	Change in Average Real Variability from pre-intervention 48h Ambulatory Blood Pressure Monitor (ABPM) and post-intervention 48 ABPM