Correlates and Control of Blood Pressure Variability

ConditionBlood Pressure Variability

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorCedars-Sinai Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Ambulatory Blood Pressure Monitor (ABPM)Other 1 intervention

Trial outcomes

Primary outcomes

Change in Blood Pressure Variability

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

Time frame

48 hours

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: