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NCT Number: NCT07400042

Peripheral Venous Pressure (PVP) 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location contact

Khawaja A Ammar, MD

CONTACT

[email protected]

414-649-6181

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard clinical care

Other

Usual standard clinical care

Primary outcomes

  1. Length of hospital stay

    Time frame: up to day 8

    Number of days from admission to discharge

  2. Number of subjects rehospitalized

    Time frame: Day 30 post index hospitalization

    Number of subjects in each group who have been rehospitalized

  3. Number of subjects rehospitalized

    Time frame: Month 6 post index hospitalization

    Number of subjects in each group who have been rehospitalized

Secondary outcomes

  1. Number of subjects with exertional dyspnea

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

    Number of subjects in each group experiencing dyspnea according to the New York Heart Association Class

  2. Number of subjects with exertional orthopnea

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

    Number of subjects in each group experiencing orthopnea according to the New York Heart Association Class

  3. Number of subjects with new need for dialysis during index hospitalization

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

    Number of subjects in each group with new need for dialysis during index hospitalization

  4. Number of subjects with diuretic use

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

    Number of subjects in each group with diuretic use during index hospitalization

  5. Number of subjects with echocardiograms

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

    Number of subjects in each group with echocardiograms performed (with results) during index hospitalization

  6. Number of subjects with all-cause death

    Time frame: Month 6 post index hospitalization

    Number of subjects in each group with all-cause death

  7. Number of subjects with cardiac-related death

    Time frame: Month 6 post index hospitalization

    Number of subjects in each group with cardiac-related death

Study contacts

Contact information is provided by the study sponsor or research team.

Khawaja Ammar, MD

CONTACT

[email protected]

(414) 649-6181

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Feb 10, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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