Correlates and Control of Blood Pressure Variability

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Blood Pressure Variability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Low BPV Regimen

Drug

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 meet target SBP. Other antihypertensive medications will be suggested to be discontinued as the SBP target is reached. Patients not meeting target SBP on maximally tolerated Amlodipine and Indapamide will be suggested to have a long acting angiotensin-converting enzyme (ACE)/ angiotensin receptor blocker (ARB) added to their therapy. Patients will complete another 48-hour ABPM after 1 week at target SBP on the low-BPV regimen.

Primary outcomes

Change in Blood Pressure Variability

Time frame: 48 hours

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

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Ebinger

CONTACT

[email protected]

3104230925

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Aug 25, 2023
Registry last updated: Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting