Peripheral Venous Pressure (PVP) Trial

NCT07400042 | Not Yet Recruiting DMC

• 1 other identifier: IRB00142526
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congestive Heart Failure

Keywords

peripheral venous pressure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Number of subjects with exertional dyspnea

  Day 1 and date of discharge (up to day 8)

• Number of subjects with exertional orthopnea

  Day 1 and date of discharge (up to day 8)

• Number of subjects with new need for dialysis during index hospitalization

  Day 1 and date of discharge (up to day 8)

• Number of subjects with diuretic use

  Day 1 and date of discharge (up to day 8)

• Number of subjects with echocardiograms

  Day 1 and date of discharge (up to day 8)

Study Arms (2)

peripheral venous pressure measurements

EXPERIMENTAL

Peripheral venous pressure measures provided to physicians daily up to 8 days

Other: peripheral venous pressure measurements

standard clinical care

ACTIVE COMPARATOR

Usual standard clinical care, peripheral venous pressure measures not provided to physician daily

Other: standard clinical care

Interventions

standard clinical care OTHER

Usual standard clinical care

standard clinical care

peripheral venous pressure measurements OTHER

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.

peripheral venous pressure measurements

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Khawaja Ammar, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khawaja Ammar, MD

CONTACT

(414) 649-6181; Khawaja.Ammar@aah.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 10, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): August 1, 2031
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)