Blood Pressure ControlACT-BPNCT07208669
Evaluating Whether Treating Elevated Blood Pressure in the Inpatient Setting Impacts Patient Outcomes
A study testing ACT-BP Intervention in people with Blood Pressure Control, run by Elizabeth Pfoh at 2 sites in United States.
Trial summary
The vast majority of the 36.2 million individuals admitted to U.S. hospitals are diagnosed with hypertension and experience an elevated blood pressure (BP) reading during hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure Control
- What is being tested?
- ACT-BP Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Nov 2025to 31 Jul 2027
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the unit level: Medical units that do not typically care for patients requiring step-down care.
Who cannot join
- Patients less than 18
- Patients experiencing hypertensive emergencies or cardiac symptoms
- Patients with active cardiovascular events, such as
- Stroke
- Non-ST-elevation
- Myocardial infarction
Show all 14Show fewer
- End-stage renal disease
- Patients on dialysis
- Those with acute decompensated heart failure
- 3. Patients on the unit for more than 10 days
- 4. Patients transferred in after being in the intensive care unit (ICU)
- 5. Pregnant and post-partum women
- 6. Patients discharged within 24 hours of admission
- 7. Patients whose systolic BP remains below 160 mmHg during hospitalization.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Emma J Wensink, 216-442-5341, wensine2@ccf.org
Elizabeth Pfoh
- Recruiting
Cleveland Clinic Hillcrest
Mayfield Heights, Ohio, 44124
Emma J Wensink, 216-442-5341, wensine2@ccf.org
Elizabeth Pfoh
About this study
Official title: Evaluating Whether Treating Elevated Blood Pressure in the Inpatient Setting Impacts Patient Outcomes: the ACT-BP Pilot
The vast majority of the 36.2 million individuals admitted to U.S. hospitals are diagnosed with hypertension and experience an elevated blood pressure (BP) reading during hospitalization. There are no guidelines for managing asymptomatically elevated BPs in the inpatient setting, and growing observational evidence suggests that antihypertensive medication intensification increases harm. The proposed study tests whether a unit-based intervention (ACT-BP) can reduce antihypertensive medication intensification and provides information that is scientifically necessary for designing a cluster-randomized clinical trial that identifies the impact of intensification after experiencing an asymptomatically elevated BP on patient outcomes.
Read the detailed description
Approximately 50-72% of the 36.2 million individuals admitted to U.S. hospitals are diagnosed with hypertension. Hypertension increases the risk of devastating cardiovascular outcomes, such as strokes, heart attacks, and heart failure. Three-quarters of admitted patients experience at least one elevated blood pressure (BP) (>140/90) during hospitalization. While BP is usually elevated for benign reasons, including pain and anxiety, acutely elevated BP can cause end-organ damage. Currently, no guidelines exist for managing asymptomatically elevated BP in the inpatient setting. There is growing observational evidence that antihypertensive medication intensification for asymptomatically elevated BP can result in adverse outcomes, such as increased readmission. Since observational studies are biased, a large-scale clinical trial is needed to identify whether to treat asymptomatically elevated BPs in the hospital. Yet, it would be unethical and costly to randomize individual patients to receive antihypertensive medication intensification. To overcome these obstacles, this study uses hospital-unit-level intervention, ACT-BP. ACT-BP removes standing orders to call physicians about elevated BPs (which encourages treatment due to social desirability bias), provides education on the potential harm of treating asymptomatically elevated BPs, and suggests alternative procedures (e.g., monitoring BP more frequently). At the end of the study, three specific pieces of knowledge needed to conduct a larger, adequately powered randomized clinical trial will be obtained. First, how much does ACT-BP reduce antihypertensive medication intensification? Second, what refinements will improve its effectiveness? Third, what is the rate of the composite outcome in the intervention and control units?
- Conditions
- Blood Pressure Control
- Being tested
- ACT-BP Intervention
- Keywords
- hypertension, inpatient
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-BP InterventionOther
In our intervention units, the study team will change the unit-based protocols to follow the ACT-BP intervention. First, it prompts the nurse to identify if a patient is experiencing hypertensive emergencies or cardiac symptoms. If so, it suggests calling the physician. If not, it prompts assessment for pain, anxiety, nausea, or hunger and provides evidence-based suggestions. It also prompts monitoring to enhance patients' safety in the case of rapidly rising BP. This algorithm will provide a path for ensuring patients receive appropriate treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The ACT-BP protocol will be implemented in the intervention units. First, the study team will implement an order on the unit that prompts the nurses to follow the ACT-BP algorithm when a patient has an asymptomatic elevated BP between 160mmHg and 199mmHg. This protocol does not apply to patients who are experiencing hypertensive emergencies or cardiac symptoms. To increase adherence to the ACT-BP protocol, knowledge related to treating the potential underlying causes of an asymptomatically elevated BP and the current state of the evidence will be shared through posters, information sheets and knowledge sessions.
At the the intervention hospital, the study team will provide caregivers (including physicians) with knowledge related to the state of the evidence for treating asymptomatically elevated BPs through emails, information sheets and one-pagers. Receives: Other: ACT-BP Intervention |
| Control Arm | No intervention | In the control units, care will continue as usual. At the the control hospital, caregivers (including physicians) will receive knowledge related to the state of the evidence for treating asymptomatically elevated BPs through an email. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
The number of new orders for antihypertensive medications or increased doses of an antihypertensive medication for patients who experience an elevated systolic BP (≥160 mmHg and ≤199 mmHg).
Measured: From date of first elevated BP reading until the end of hospitalization, assessed up to 13 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start11 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure ControlStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elizabeth Pfoh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Elizabeth Pfoh, The Cleveland Clinic
- Investigators
- Elizabeth Pfoh, PhD, MPH, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208669
- Sponsor's protocol ID
- 24-1160
- Other IDs
- 1R34HL173138-01A1
- Acronym
- ACT-BP
- Status last verified
- Jan 2026
- First submitted
- 19 Sep 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from the pilot trial will be deposited into a public repository.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Whether Treating Elevated Blood Pressure in the Inpatient Setting Impacts Patient Outcomes: the ACT-BP Pilot
- ClinicalTrials.gov ID
- NCT07208669
- Acronym / sponsor ID
- ACT-BP / 24-1160
- Conditions
- Blood Pressure Control
- Keywords
- hypertension, inpatient
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Elizabeth PfohUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 6 Oct 2025 (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 vast majority of the 36.2 million individuals admitted to U.S. hospitals are diagnosed with hypertension and experience an elevated blood pressure (BP) reading during hospitalization. There are no guidelines for managing asymptomatically elevated BPs in the inpatient setting, and growing observational evidence suggests that antihypertensive medication intensification increases harm. The proposed study tests whether a unit-based intervention (ACT-BP) can reduce antihypertensive medication intensification and provides information that is scientifically necessary for designing a cluster-randomized clinical trial that identifies the impact of intensification after experiencing an asymptomatically elevated BP on patient outcomes.
Detailed description
Approximately 50-72% of the 36.2 million individuals admitted to U.S. hospitals are diagnosed with hypertension. Hypertension increases the risk of devastating cardiovascular outcomes, such as strokes, heart attacks, and heart failure. Three-quarters of admitted patients experience at least one elevated blood pressure (BP) (>140/90) during hospitalization. While BP is usually elevated for benign reasons, including pain and anxiety, acutely elevated BP can cause end-organ damage. Currently, no guidelines exist for managing asymptomatically elevated BP in the inpatient setting. There is growing observational evidence that antihypertensive medication intensification for asymptomatically elevated BP can result in adverse outcomes, such as increased readmission. Since observational studies are biased, a large-scale clinical trial is needed to identify whether to treat asymptomatically elevated BPs in the hospital. Yet, it would be unethical and costly to randomize individual patients to receive antihypertensive medication intensification. To overcome these obstacles, this study uses hospital-unit-level intervention, ACT-BP. ACT-BP removes standing orders to call physicians about elevated BPs (which encourages treatment due to social desirability bias), provides education on the potential harm of treating asymptomatically elevated BPs, and suggests alternative procedures (e.g., monitoring BP more frequently). At the end of the study, three specific pieces of knowledge needed to conduct a larger, adequately powered randomized clinical trial will be obtained. First, how much does ACT-BP reduce antihypertensive medication intensification? Second, what refinements will improve its effectiveness? Third, what is the rate of the composite outcome in the intervention and control units?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: ACT-BP InterventionThe ACT-BP protocol will be implemented in the intervention units. First, the study team will implement an order on the unit that prompts the nurses to follow the ACT-BP algorithm when a patient has an asymptomatic elevated BP between 160mmHg and 199mmHg. This protocol does not apply to patients who are experiencing hypertensive emergencies or cardiac symptoms. To increase adherence to the ACT-BP protocol, knowledge related to treating the potential underlying causes of an asymptomatically elevated BP and the current state of the evidence will be shared through posters, information sheets and knowledge sessions. At the the intervention hospital, the study team will provide caregivers (including physicians) with knowledge related to the state of the evidence for treating asymptomatically elevated BPs through emails, information sheets and one-pagers. |
| Control Arm | No intervention | –In the control units, care will continue as usual. At the the control hospital, caregivers (including physicians) will receive knowledge related to the state of the evidence for treating asymptomatically elevated BPs through an email. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At the unit level: Medical units that do not typically care for patients requiring step-down care.
Key exclusion criteria (14 listed)
- Patients less than 18
- Patients experiencing hypertensive emergencies or cardiac symptoms
- Patients with active cardiovascular events, such as
- 3. Patients on the unit for more than 10 days
- 4. Patients transferred in after being in the intensive care unit (ICU)
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 |
|---|---|---|
| ACT-BP InterventionIn our intervention units, the study team will change the unit-based protocols to follow the ACT-BP intervention. First, it prompts the nurse to identify if a patient is experiencing hypertensive emergencies or cardiac symptoms. If so, it suggests calling the physician. If not, it prompts assessment for pain, anxiety, nausea, or hunger and provides evidence-based suggestions. It also prompts monitoring to enhance patients' safety in the case of rapidly rising BP. This algorithm will provide a path for ensuring patients receive appropriate treatment. | Other | Intervention Arm |
Primary outcome
Primary Outcome
Time frame: From date of first elevated BP reading until the end of hospitalization, assessed up to 13 months.
The number of new orders for antihypertensive medications or increased doses of an antihypertensive medication for patients who experience an elevated systolic BP (≥160 mmHg and ≤199 mmHg).
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 8 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified data from the pilot trial will be deposited into a public repository.
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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.
Elizabeth Pfoh, PhD, MPH principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-BP Intervention in people with Blood Pressure Control, run by Elizabeth Pfoh at 2 sites in United States.
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 1 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Elizabeth Pfoh, PhD, MPH (12162963034, pfohe@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: From date of first elevated BP reading until the end of hospitalization, assessed up to 13 months.). 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 8 Jan 2026.