Evaluating Whether Treating Elevated Blood Pressure in the Inpatient Setting Impacts Patient Outcomes

NCT07208669 | Recruiting DMC

• 2 other identifiers: 24-11601R34HL173138-01A1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Blood Pressure Control

Keywords

hypertension; inpatient

Outcome Measures

Primary Outcomes (1)

• 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).

  From date of first elevated BP reading until the end of hospitalization, assessed up to 13 months.

Study Arms (2)

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.

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.

Interventions

ACT-BP Intervention OTHER

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At the unit level: Medical units that do not typically care for patients requiring step-down care.

You may not qualify if:

• Patients less than 18
• Patients experiencing hypertensive emergencies or cardiac symptoms
• Patients with active cardiovascular events, such as
• Stroke
• Non-ST-elevation
• Myocardial infarction
• End-stage renal disease
• Patients on dialysis
• Those with acute decompensated heart failure
• \. Patients on the unit for more than 10 days
• \. Patients transferred in after being in the intensive care unit (ICU)
• \. Pregnant and post-partum women
• \. Patients discharged within 24 hours of admission
• \. Patients whose systolic BP remains below 160 mmHg during hospitalization.

Sponsors & Collaborators

• Elizabeth Pfoh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

RECRUITING

Cleveland Clinic Hillcrest

Mayfield Heights, Ohio, 44124, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elizabeth Pfoh, PhD, MPH

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Pfoh, PhD, MPH

CONTACT

12162963034; pfohe@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff/Associate Professor of Medicine

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 6, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the end of the grant period (August 2027) the supporting information will be available and it will be available for 6 years.
• Access Criteria: The research community will have access to our findings at the end of the grant period. Since this is a short (2-year) grant, preliminary results will not be shared. The final dataset of de-identified quantitative results will be shared on Vivli, provided appropriate privacy safeguards are available. Alternatively, the de-identified data will be made available upon request under an FDP Data Use Agreement or similar transfer mechanism. Research can request the qualitative results directly from the Principal Investigator at Cleveland Clinic. Cleveland Clinic will consider each request on an individual basis, with combined input from the Principal Investigator, the Law Department, and the Institutional Review Board. Consistent with Cleveland Clinic policy, the data will be available for six years following the end of the grant period.

Locations

US (2)