Peripheral Venous Pressure (PVP) Trial

Reducing the Length of Stay and Incidence of Rehospitalization in Heart Failure Patients by Measuring Peripheral Venous Pressure; a Randomized Clinical Trial

The purpose of the study is to determine if there is a reduction in the length of stay and rates of rehospitalization for patients diagnosed with congestive heart failure when physicians are provided daily measurements of peripheral venous pressure versus no daily measurements of peripheral venous pressure.

Study Overview

• Status: Not yet recruiting
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Other: peripheral venous pressure measurements; Other: standard clinical care

Detailed Description

The objective of the study is to evaluate the effectiveness of standard clinical care versus standard clinical care directed by peripheral venous pressure on length of hospital stay and incidence of rehospitalization among heart failure patients.

The study team hypothesizes that compared to standard clinical care the peripheral venous pressure-guided therapy is associated with shorter hospital stay and lesser incidence of 30-day rehospitalization. The study team will also collect data to determine if peripheral venous pressure-guided care is associated with reduced incidence of 6-month rehospitalization, improvement in symptoms or lab indices, lesser new incidence of dialysis, change in use of diuretics, and lesser use of echocardiograms.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khawaja Ammar, MD; Phone Number: (414) 649-6181; Email: Khawaja.Ammar@aah.org

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center
      • Contact: Khawaja A Ammar, MD; Phone Number: 414-649-6181; Email: Khawaja.Ammar@aah.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with minimum 3-month history of Congestive Heart Failure admitted to Aurora St. Luke's Medical Center with acute decompensation
• English speaking only

Exclusion Criteria:

• Patients who do not already have a peripheral IV line inserted
• Patients whose IV line cannot be transduced
• Patients with current or past vein thrombosis in the arm used to measure the pressure or with history of recurrent (>1) pulmonary embolism
• Patients with active thrombophlebitis in the arm
• Patients who have experienced a major cardiovascular event (myocardial infarction, stroke, etc.) ≤2 months prior to the admission date
• Patients who have received an implanted cardiac resynchronization device (pacemaker or ICD) ≤3 months prior to admission date
• Patients enrolled in other cardiovascular research studies.
• Patients with a clinical condition that the investigator believes may not allow the patient to complete the study, at the discretion of the investigator. Examples of conditions that may apply include severe stenotic valvular disease, isolated right ventricle failure, precapillary pulmonary hypertension, hypertrophic obstructive cardiomyopathy, implanted left ventricular assist device, history of heart transplantation, clinical diagnosis of cardiogenic shock, any left-to-right shunt
• Patients with congenital heart disease or mechanical right heart valve(s)
• Planned heart surgery and/or coronary intervention during hospitalization
• Patients expected to receive heart transplant within 6 months of admission
• IV cannula smaller than 22G
• Patients who are pregnant and/or lactating
• Patients who are unable to provide informed consent
• Patients who are intubated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: peripheral venous pressure measurements; Peripheral venous pressure measures provided to physicians daily up to 8 days	Other: peripheral venous pressure measurements; Peripheral venous pressure measures provided to physicians daily up to 8 days, with a research note in the electronic medical record containing standardized recommendations for case also provided daily. Care changes up to clinical provider discretion.
Active Comparator: standard clinical care; Usual standard clinical care, peripheral venous pressure measures not provided to physician daily	Other: standard clinical care; Usual standard clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Number of days from admission to discharge	up to day 8
Number of subjects rehospitalized	Number of subjects in each group who have been rehospitalized	Day 30 post index hospitalization
Number of subjects rehospitalized	Number of subjects in each group who have been rehospitalized	Month 6 post index hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with exertional dyspnea	Number of subjects in each group experiencing dyspnea according to the New York Heart Association Class	Day 1 and date of discharge (up to day 8)
Number of subjects with exertional orthopnea	Number of subjects in each group experiencing orthopnea according to the New York Heart Association Class	Day 1 and date of discharge (up to day 8)
Number of subjects with new need for dialysis during index hospitalization	Number of subjects in each group with new need for dialysis during index hospitalization	Day 1 and date of discharge (up to day 8)
Number of subjects with diuretic use	Number of subjects in each group with diuretic use during index hospitalization	Day 1 and date of discharge (up to day 8)
Number of subjects with echocardiograms	Number of subjects in each group with echocardiograms performed (with results) during index hospitalization	Day 1 and date of discharge (up to day 8)
Number of subjects with all-cause death	Number of subjects in each group with all-cause death	Month 6 post index hospitalization
Number of subjects with cardiac-related death	Number of subjects in each group with cardiac-related death	Month 6 post index hospitalization

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Khawaja Ammar, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: peripheral venous pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: IRB00142526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes