Correlates and Control of Blood Pressure Variability

Blood Pressure Variability Clinical Trial

Official title:

Correlates and Control of Blood Pressure Variability

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06012487
• Other study ID #: STUDY02827
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: Joseph Ebinger
• Phone: 3104230925
• Email: cda-research[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Blood Pressure Variability

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Blood Pressure Variability	Change in Average Real Variability from pre-intervention 48h Ambulatory Blood Pressure Monitor (ABPM) and post-intervention 48 ABPM	48 hours