Blood Pressure VariabilityPhase 1NCT06012487
Correlates and Control of Blood Pressure Variability
A Phase 1 study testing Low BPV Regimen in people with Blood Pressure Variability, run by Cedars-Sinai Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Variability
- What is being tested?
- Low BPV Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Blood Pressure Variability
- Being tested
- Low BPV Regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low BPV RegimenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory Blood Pressure Monitor (ABPM) | Other | 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. Receives: Drug: Low BPV Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Pressure Variability
Change in Average Real Variability from pre-intervention 48h Ambulatory Blood Pressure Monitor (ABPM) and post-intervention 48 ABPM
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 May 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure VariabilityStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a feasibility study of the feasibility of helping physicians select a protocol to reduce BPV in hypertensive patients on antihypertensive therapy. The duration of the study for Aim 2 is 2 visits, the first with a 48 hour ABPM and the second for a repeat 48 hour ABPM following any changes made at the discretion of the treating provider. The optional sub-study is also a feasibility study, designed to demonstrate the ability to simultaneously capture ABPM and SKNA data.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Ebinger, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012487
- Sponsor's protocol ID
- STUDY02827
- Status last verified
- Feb 2025
- First submitted
- 21 Aug 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlates and Control of Blood Pressure Variability
- ClinicalTrials.gov ID
- NCT06012487
- Acronym / sponsor ID
- STUDY02827
- Conditions
- Blood Pressure Variability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a feasibility study of the feasibility of helping physicians select a protocol to reduce BPV in hypertensive patients on antihypertensive therapy. The duration of the study for Aim 2 is 2 visits, the first with a 48 hour ABPM and the second for a repeat 48 hour ABPM following any changes made at the discretion of the treating provider. The optional sub-study is also a feasibility study, designed to demonstrate the ability to simultaneously capture ABPM and SKNA data.
| Arm | Type | Receives |
|---|---|---|
| Ambulatory Blood Pressure Monitor (ABPM) | Other | Drug: Low BPV RegimenParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low BPV RegimenEach 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. | Drug | Ambulatory Blood Pressure Monitor (ABPM) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low BPV Regimen in people with Blood Pressure Variability, run by Cedars-Sinai Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Ebinger (3104230925, cda-research@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Pressure Variability (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.