Advanced Monitoring for High Blood Pressure

Overseen By Cristina Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Non-English speaking, Pregnant, Congenital heart defect, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of the procedure

120 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Advanced Monitoring for High Blood Pressure is an effective treatment?

The available research shows that Advanced Monitoring for High Blood Pressure, specifically the CardioMEMS system, is effective in managing heart failure, which is a related condition. This system helps reduce hospitalizations and improve the quality of life for patients by allowing healthcare providers to monitor heart pressure remotely and intervene early. Although the studies focus on heart failure, the success in reducing hospital visits and improving patient outcomes suggests that similar monitoring systems could be beneficial for managing high blood pressure. ^{1 2 3 4 5}

What safety data exists for the HemoSphere Advanced Monitoring Platform and related devices?

The provided research does not contain specific safety data for the HemoSphere Advanced Monitoring Platform or its related devices like the Acumen IQ sensor and Tissue Oximetry Monitoring. The studies mentioned focus on other monitoring technologies and their applications, but do not address the safety of the HemoSphere devices directly. ^{6 7 8 9 10}

Is the treatment in the trial 'Advanced Monitoring for High Blood Pressure' a promising treatment?

Yes, the treatment using the Spacelabs 90207 monitor is promising because it allows for continuous and non-invasive monitoring of blood pressure outside of a hospital setting. This can help provide a more accurate picture of a person's blood pressure throughout the day, similar to invasive methods, which is valuable for managing high blood pressure. ^{11 12 13 14 15}

What is the purpose of this trial?

A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets

Eligibility Criteria

This trial is for people aged 45 or older at high risk of stroke or other brain blood flow problems due to conditions like high blood pressure, diabetes, previous strokes, smoking, or vascular disease. They're planning heart surgery with a specific type of monitoring and have agreed to participate.

Inclusion Criteria

I am 45 years old or older.

I am at high risk for stroke or brain blood vessel issues due to conditions like high blood pressure, diabetes, or smoking.

I am scheduled for heart surgery that will use a heart-lung machine.

Exclusion Criteria

I have had surgery for a heart defect I was born with.

Non-availability of HemoSphere with laptop CAI interface

Non-English speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiopulmonary bypass with blood pressure and oximetry monitoring

Duration of the procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring

Trial Overview The study is testing the HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring to set personalized blood pressure targets during cardiac surgery in a single-center observational pilot.

Participant Groups

Group I: Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Findings from Research

The Biomon-HF project developed and tested innovative sensors for monitoring vital signs during sleep in 115 heart failure patients, showing promise for personalized telemonitoring and therapy management.

These sensors can help detect heart failure exacerbations and related health issues early, potentially reducing complications and healthcare costs while improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized biomonitoring in heart failure--Biomon-HF "Keep an eye on heart failure--especially at night". Vollmer, T., Schauerte, P., Zink, M., et al.[2015]

Remote hemodynamic monitoring using the CardioMEMS HF system allows for early detection of heart failure by measuring pulmonary artery pressures, which can help prevent hospitalizations by enabling timely interventions.

Clinical evidence supports the efficacy and safety of the CardioMEMS system, highlighting its potential as a valuable tool in managing chronic heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CardioMEMS™: a tool for remote hemodynamic monitoring of chronic heart failure patients. Radhoe, SP., Brugts, JJ.[2022]

The CardioMEMSTM system, which continuously monitors pulmonary arterial pressure (PAP) in heart failure patients, has been shown to significantly reduce hospitalizations related to heart failure and overall mortality.

Access to real-time hemodynamic data from the CardioMEMSTM device allows for timely adjustments in medical therapy, leading to earlier interventions such as left ventricular assist device implantation and shorter wait times for heart transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory pulmonary artery pressure monitoring in advanced heart failure patients. Yandrapalli, S., Raza, A., Tariq, S., et al.[2020]

The CardioMEMSTM HF system is a wireless monitoring tool that tracks pulmonary artery pressure, allowing healthcare providers to detect early signs of heart failure decompensation and adjust treatments promptly, which can help prevent rehospitalization.

Data from trials and registries indicate that using the CardioMEMSTM system is associated with reduced heart failure hospitalization rates and improved quality of life, making it a safe and cost-effective option for managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CardioMEMSTM System in the Daily Management of Heart Failure: Review of Current Data and Technique of Implantation. Mangi, MA., Nesheiwat, Z., Kahloon, R., et al.[2022]

In the CHAMPION trial, patients with ambulatory pulmonary artery pressure (PAP) monitoring showed significantly lower rates of heart failure hospitalizations (HFH) and all-cause readmissions within 30 and 90 days after hospitalization, indicating improved management of heart failure.

A retrospective analysis of 459 patients revealed a 45% reduction in 90-day all-cause readmission rates post-PAP sensor implantation, demonstrating the effectiveness of this monitoring approach in enhancing patient outcomes in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in 90 day readmission rates utilizing ambulatory pulmonary pressure monitoring. Valika, A., Sulemanjee, N., Pedersen, R., et al.[2023]

In a study involving 14 patients undergoing hemodialysis, it was found that the relative blood volume change (DeltaRBV) measurements from three different devices (Hemoscan, Crit-Line, and BVM) differed significantly from those calculated using laboratory-derived hemoglobin changes, indicating potential inaccuracies in device measurements.

The comparison of DeltaRBV results among the devices revealed substantial discrepancies, with significant differences noted between the Hemoscan and Crit-Line devices, suggesting that the choice of monitoring device could impact the management of hemodialysis hypotension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative blood volume measurements during hemodialysis: comparisons between three noninvasive devices. Dasselaar, JJ., Huisman, RM., DE Jong, PE., et al.[2007]

The LifeGuard system, developed by NASA Ames Research Center and Stanford University, is a lightweight and unobtrusive wearable device designed to monitor vital signs in real-time, making it suitable for mobile applications like space missions and healthcare.

This system is capable of logging vital signs for several hours and transmitting data securely, which enhances its usability for various fields, including clinical settings, home health monitoring, and military operations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifeguard--a personal physiological monitor for extreme environments. Montgomery, K., Mundt, C., Thonier, G., et al.[2020]

In a study involving 583 patients across 27 cardiology practices, the ZOLL Arrhythmia Monitoring System, which combines ECG data with additional biometric information, led to treatment plan changes in 96% of cases, demonstrating its significant impact on patient management.

The integration of biometric data allowed for modifications in medications, follow-up, and lifestyle changes for 64% of patients, suggesting that this next-generation monitoring system enhances the ability of physicians to assess cardiovascular risks and improve overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next-generation Mobile Cardiac Telemetry: Clinical Value of Combining Electrocardiographic and Physiologic Parameters. Yoo, D., Bhalla, K., Manyam, H., et al.[2022]

The HemoCue Hb 201+ is a portable device that allows for quick and accurate measurement of hemoglobin levels from various blood sources, which is crucial for monitoring patients in dialysis units.

In a study involving 148 hemoglobin measurements, the device demonstrated its effectiveness, providing flexibility for outpatient dialysis centers to manage patient care and erythropoietin treatment more efficiently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[HemoCue: preliminary considerations about its use in hemodialysis]. Montagnac, R., Vitry, F., Rehn, Y., et al.[2007]

Non-invasive monitoring technologies, like pulse oximetry for measuring hemoglobin levels (SpHb), provide continuous and unobtrusive data that can be transmitted directly to caregivers, enhancing patient safety.

The study confirms that SpHb's trend accuracy can prompt earlier laboratory testing for hemoglobin levels, allowing for timely identification of issues like postoperative bleeding, which can prevent serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive monitoring is coming the full circle, making our patients safer! Ramsay, MA.[2021]

Recent advancements in ambulatory blood pressure monitoring devices have led to improvements in their design, making them lighter, quieter, and more accurate for intermittent measurements.

While newer devices like the SpaceLabs 90202 and 90207 show some inaccuracies, they effectively capture hour-to-hour blood pressure changes that closely resemble those from invasive methods, allowing for a more accurate 24-hour blood pressure profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the accuracy of blood pressure monitoring devices in ambulatory conditions. Parati, G., Groppelli, A., Omboni, S., et al.[2007]

The SpaceLabs 90207 monitor demonstrated a high level of accuracy in measuring blood pressure, with mean differences of only 1.59 mmHg for systolic and 1.05 mmHg for diastolic blood pressure compared to the mercury sphygmomanometer, based on a study of 86 patients.

The monitor met the British Hypertension Society's validation criteria, achieving grade B for most blood pressure measurements, indicating it is a reliable tool for outpatient blood pressure monitoring, although it showed some limitations in patients over 65 years for systolic readings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An evaluation of the Spacelabs 90207 model of the ambulatory arterial pressure monitoring system]. Mayoral Sánchez, E., Díez Naz, AD., Lapetra Peralta, J., et al.[2007]

In a study comparing two ambulatory blood pressure monitors, the Spacelabs device recorded significantly higher systolic blood pressure readings than the Mobil-O-Graph, with differences of 10.2 mm Hg in nonrandomized and 7.9 mm Hg in randomized settings.

The mean arterial pressures were only slightly different (1-2 mm Hg) between the two devices, while heart rates measured were nearly identical, suggesting that while systolic readings vary, overall heart rate monitoring may be consistent across devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two ambulatory blood pressure monitors worn at the same time. Kallem, RR., Meyers, KE., Sawinski, DL., et al.[2021]

The Spacelabs 90207 model for non-invasive blood pressure monitoring has been validated as effective, meeting the standards set by the British Hypertension Society and the Association for the Advancement of Medical Instrumentation.

In a study involving 90 participants, the Spacelabs 90207 showed comparable blood pressure readings to traditional manual measurements, indicating its reliability for monitoring blood pressure in a primary care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of Spacelabs 90207, the noninvasive automatic monitor for ambulatory monitoring of blood pressure]. Márquez Contreras, E., López de Andrés, M., Casado Martínez, JJ., et al.[2016]

A study comparing three software versions of the SpaceLabs model 90202 blood pressure monitor found that unannounced software updates can significantly affect mean arterial pressure (MAP) measurements, with the latest version showing a 5.4 mmHg increase in MAP compared to older versions.

The findings highlight the importance of using the same monitor for each patient in clinical trials to ensure reliable blood pressure readings, as even monitors with the same software version can yield different results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A plea for consistent reliability in ambulatory blood pressure monitors: a reminder. Hansen, KW., Orskov, H.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Individualized biomonitoring in heart failure--Biomon-HF "Keep an eye on heart failure--especially at night". [2015]

2. England pubmed.ncbi.nlm.nih.gov

CardioMEMS™: a tool for remote hemodynamic monitoring of chronic heart failure patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Ambulatory pulmonary artery pressure monitoring in advanced heart failure patients. [2020]

4. England pubmed.ncbi.nlm.nih.gov

CardioMEMSTM System in the Daily Management of Heart Failure: Review of Current Data and Technique of Implantation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Reduction in 90 day readmission rates utilizing ambulatory pulmonary pressure monitoring. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Relative blood volume measurements during hemodialysis: comparisons between three noninvasive devices. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Lifeguard--a personal physiological monitor for extreme environments. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Next-generation Mobile Cardiac Telemetry: Clinical Value of Combining Electrocardiographic and Physiologic Parameters. [2022]

9. France pubmed.ncbi.nlm.nih.gov

[HemoCue: preliminary considerations about its use in hemodialysis]. [2007]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Non-invasive monitoring is coming the full circle, making our patients safer! [2021]

11. England pubmed.ncbi.nlm.nih.gov

Testing the accuracy of blood pressure monitoring devices in ambulatory conditions. [2007]

12. Spain pubmed.ncbi.nlm.nih.gov

[An evaluation of the Spacelabs 90207 model of the ambulatory arterial pressure monitoring system]. [2007]

13. United States pubmed.ncbi.nlm.nih.gov

A comparison of two ambulatory blood pressure monitors worn at the same time. [2021]

14. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of Spacelabs 90207, the noninvasive automatic monitor for ambulatory monitoring of blood pressure]. [2016]

15. Netherlands pubmed.ncbi.nlm.nih.gov

A plea for consistent reliability in ambulatory blood pressure monitors: a reminder. [2019]