Congestive Heart FailureNCT07400042
Peripheral Venous Pressure (PVP) Trial
A study testing peripheral venous pressure measurements and standard clinical care in people with Congestive Heart Failure, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- peripheral venous pressure measurements and standard clinical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2026to Oct 2031
- 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
- Patients with minimum 3-month history of Congestive Heart Failure admitted to Aurora St. Luke's Medical Center with acute decompensation
- English speaking only
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Khawaja A Ammar, MD, 414-649-6181, Khawaja.Ammar@aah.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Congestive Heart Failure
- Being tested
- peripheral venous pressure measurements, standard clinical care
- Keywords
- peripheral venous pressure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral venous pressure measurementsOther
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 careOther
Usual standard clinical care
| Study group | Role | What they receive |
|---|---|---|
| peripheral venous pressure measurements | Experimental | Peripheral venous pressure measures provided to physicians daily up to 8 days Receives: Other: peripheral venous pressure measurements |
| standard clinical care | Active comparator | Usual standard clinical care, peripheral venous pressure measures not provided to physician daily Receives: Other: standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Number of days from admission to discharge
Measured: up to day 8
Number of subjects rehospitalized
Number of subjects in each group who have been rehospitalized
Measured: Day 30 post index hospitalization
Number of subjects rehospitalized
Number of subjects in each group who have been rehospitalized
Measured: Month 6 post index hospitalization
Secondary outcomes (7)
Number of subjects with exertional dyspnea
Number of subjects in each group experiencing dyspnea according to the New York Heart Association Class
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Month 6 post index hospitalization
Number of subjects with cardiac-related death
Number of subjects in each group with cardiac-related death
Measured: Month 6 post index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start5 Oct 2026
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khawaja Ammar, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400042
- Sponsor's protocol ID
- IRB00142526
- Status last verified
- Aug 2026
- First submitted
- 21 Jan 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Length of Stay and Incidence of Rehospitalization in Heart Failure Patients by Measuring Peripheral Venous Pressure; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07400042
- Acronym / sponsor ID
- IRB00142526
- Conditions
- Congestive Heart Failure
- Keywords
- peripheral venous pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 10 Feb 2026 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peripheral venous pressure measurements | Experimental | Other: peripheral venous pressure measurementsPeripheral venous pressure measures provided to physicians daily up to 8 days |
| standard clinical care | Active comparator | Other: standard clinical careUsual standard clinical care, peripheral venous pressure measures not provided to physician daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with minimum 3-month history of Congestive Heart Failure admitted to Aurora St. Luke's Medical Center with acute decompensation
- English speaking only
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| peripheral venous pressure measurementsPeripheral 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. | Other | peripheral venous pressure measurements |
| standard clinical careUsual standard clinical care | Other | standard clinical care |
Primary outcome
Length of hospital stay
Time frame: up to day 8
Number of days from admission to discharge
Number of subjects rehospitalized
Time frame: Day 30 post index hospitalization
Number of subjects in each group who have been rehospitalized
Number of subjects rehospitalized
Time frame: Month 6 post index hospitalization
Number of subjects in each group who have been rehospitalized
7 secondary outcomes
Number of subjects with exertional dyspnea
Time frame: Day 1 and date of discharge (up to day 8)
Number of subjects with exertional orthopnea
Time frame: Day 1 and date of discharge (up to day 8)
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 with diuretic use
Time frame: Day 1 and date of discharge (up to day 8)
Number of subjects with echocardiograms
Time frame: Day 1 and date of discharge (up to day 8)
Number of subjects with all-cause death
Time frame: Month 6 post index hospitalization
Number of subjects with cardiac-related death
Time frame: Month 6 post index hospitalization
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 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Khawaja Ammar, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peripheral venous pressure measurements and standard clinical care in people with Congestive Heart Failure, run by Wake Forest University Health Sciences at 1 site 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 2 inclusion and 15 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Khawaja Ammar, MD ((414) 649-6181, Khawaja.Ammar@aah.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: up to day 8). The study lists 3 primary outcomes in all. 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 7 Oct 2026.