Reducing the Length of Stay and Incidence of Rehospitalization in Heart Failure Patients by Measuring Peripheral Venous Pressure; a Randomized Clinical Trial
New trial to test if measuring vein pressure helps heart failure patients stay out of the hospital.
Plain English Summary
Peripheral Venous Pressure (PVP) Trial is a Not Applicable clinical trial sponsored by Wake Forest University Health Sciences studying Congestive Heart Failure. This trial tests if daily measurements of vein pressure help doctors reduce how long heart failure patients stay in the hospital and how often they need to be readmitted. It is for adults with congestive heart failure who are admitted to the hospital for worsening symptoms. Participants will have their vein pressure measured daily, and doctors will receive recommendations based on these measurements. Standard hospital care for heart failure is the alternative. The trial aims to enroll 600 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with a history of congestive heart failure admitted to Aurora St. Luke's Medical Center for worsening symptoms. Must be able to speak and understand English. Cannot have certain pre-existing conditions like recent major heart events, implanted heart devices within 3 months, or planned heart surgery. Cannot be pregnant or breastfeeding, or require intubation. This trial is studying Congestive Heart Failure, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will measure if patients spend fewer days in the hospital and are readmitted less often within 6 months after leaving the hospital. The specific primary outcome measures are: Length of hospital stay (up to day 8); Number of subjects rehospitalized (Day 30 post index hospitalization); Number of subjects rehospitalized (Month 6 post index hospitalization). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to improve care for heart failure patients by potentially reducing hospital stays and readmissions, addressing a significant need in managing this chronic condition. This research targets Congestive Heart Failure, where improved treatment options are needed.
Investor Insight
This trial explores a novel monitoring approach for a common and costly condition, potentially offering a new tool for hospitals and payers seeking to improve outcomes and reduce healthcare expenses. The large enrollment target of 600 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if this trial is right for you and what the potential benefits and risks are. You will have your peripheral venous pressure measured daily, and your doctor will receive information to help guide your care. Participation involves regular monitoring and follow-up for up to 6 months after discharge. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 600 participants
Interventions
- 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.
- OTHER: standard clinical care — Usual standard clinical care
Primary Outcomes
- Length of hospital stay (up to day 8)
- Number of subjects rehospitalized (Day 30 post index hospitalization)
- Number of subjects rehospitalized (Month 6 post index hospitalization)
Secondary Outcomes
- 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))
Trial Locations
- Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, United States
Frequently Asked Questions
What is clinical trial NCT07400042?
NCT07400042 is a Not Applicable INTERVENTIONAL study titled "Peripheral Venous Pressure (PVP) Trial." It is currently not yet recruiting and is sponsored by Wake Forest University Health Sciences. The trial targets enrollment of 600 participants.
What conditions does NCT07400042 study?
This trial investigates treatments for Congestive Heart Failure. The primary condition under study is Congestive Heart Failure.
What treatments are being tested in NCT07400042?
The interventions being studied include: peripheral venous pressure measurements (OTHER), standard clinical care (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.
What does Not Applicable mean for NCT07400042?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07400042?
This trial is currently "Not Yet Recruiting." It started on 2026-04. The estimated completion date is 2031-08.
Who is sponsoring NCT07400042?
NCT07400042 is sponsored by Wake Forest University Health Sciences. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07400042?
The trial aims to enroll 600 participants. The trial has not yet started recruiting.
How is NCT07400042 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07400042?
The primary outcome measures are: Length of hospital stay (up to day 8); Number of subjects rehospitalized (Day 30 post index hospitalization); Number of subjects rehospitalized (Month 6 post index hospitalization). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07400042 being conducted?
This trial is being conducted at 1 site, including Milwaukee, Wisconsin (United States).
Where can I find official information about NCT07400042?
The official record for NCT07400042 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07400042. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07400042 testing in simple terms?
This trial tests if daily measurements of vein pressure help doctors reduce how long heart failure patients stay in the hospital and how often they need to be readmitted. It is for adults with congestive heart failure who are admitted to the hospital for worsening symptoms.
Why is this trial significant?
This trial aims to improve care for heart failure patients by potentially reducing hospital stays and readmissions, addressing a significant need in managing this chronic condition.
What are the potential risks of participating in NCT07400042?
The main risk is related to the insertion of the IV line needed for pressure measurement, which can cause discomfort, bruising, or infection. Potential side effects from the treatment adjustments guided by the measurements could occur, as with any medical intervention. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07400042?
Ask your doctor if this trial is right for you and what the potential benefits and risks are. You will have your peripheral venous pressure measured daily, and your doctor will receive information to help guide your care. Participation involves regular monitoring and follow-up for up to 6 months after discharge. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07400042 signal from an investment perspective?
This trial explores a novel monitoring approach for a common and costly condition, potentially offering a new tool for hospitals and payers seeking to improve outcomes and reduce healthcare expenses. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will have their vein pressure measured daily, and doctors will receive recommendations based on these measurements. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Congestive Heart Failure Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.