What side effects are associated with this type of intervention?

Common treatments for heart failure, including those involving hemodynamic monitoring like the CardioMEMS system, often include medications such as beta-blockers, ACE inhibitors, ARBs, diuretics, and aldosterone antagonists. Known side effects of these treatments can include hypotension, electrolyte imbalances (e.g., hyperkalemia or hypokalemia), renal dysfunction, dizziness, and fatigue. Specific to hemodynamic monitoring, potential risks include device-related complications such as infection, bleeding, or sensor malfunction.

What prior FDA approvals exist?

The FDA has approved several treatments for heart failure that involve advanced monitoring technologies. One notable approval is the CardioMEMS HF System, which is a wireless monitoring device that measures pulmonary artery pressure to help manage heart failure. This system allows for proactive adjustments in therapy based on real-time data, potentially reducing hospitalizations and improving patient outcomes. Other FDA-approved treatments for heart failure include medications such as beta-blockers, ACE inhibitors, and ARBs, which are standard pharmacological therapies aimed at managing symptoms and improving heart function.

What other types of research exist?

Promising alternatives to CardioMEMS for heart failure management in 2024 include: 1) Hemodynamic-guided LVAD unloading using wireless monitoring systems, which offer real-time data and personalized management. 2) Non-invasive wearable devices that continuously monitor vital signs and hemodynamic parameters, providing early detection of heart failure exacerbations. 3) Advanced implantable sensors that measure intracardiac pressures and other relevant metrics, offering comprehensive monitoring and management of heart failure patients.

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Wireless Monitoring System

CardioMEMS Monitoring for Heart Failure

N/A

Waitlist Available

Led By Stavros Drakos, M.D.

Research Sponsored by STAVROS G DRAKOS

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Left ventricular ejection fraction <=25% and cardiomegaly at time of LVAD implantation

Severe clinical HF resistant to intensive medical therapy and requiring LVAD implantation

Must not have

Require acute or chronic renal replacement therapy within 3 months prior to enrollment

Implanted mechanical aortic and/or mitral valve(s) and/or right heart valve(s)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two ways to manage severe heart failure in patients with a mechanical heart pump (LVAD). One method uses regular treatment, while the other uses a special device (CardioMEMS) to monitor heart pressure and adjust treatment. The goal is to improve heart function and reduce hospital visits. The CardioMEMS device, an implantable pulmonary artery pressure monitor, has been shown to reduce hospitalizations and improve quality of life in patients with chronic heart failure.

Who is the study for?

This trial is for adults with severe heart failure who need an LVAD (heart pump) and have a body mass index of 35 or less. They must not be pregnant, agree to use contraception if of childbearing potential, and have had heart failure for less than 5 years. People with certain other health conditions or those participating in other heart-related trials cannot join.

What is being tested?

The study compares two methods of managing patients with LVADs: the usual care versus a special wireless monitoring system called CardioMEMS that guides treatment based on detailed heart measurements. Participants will also receive standard medications aimed at improving the structure and function of the heart.

What are the potential side effects?

While specific side effects are not listed, using CardioMEMS may include risks related to implanting the device like infection or bleeding. Standard HF medications can cause various side effects such as kidney problems, low blood pressure, electrolyte imbalances, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's pumping ability is very low and my heart was enlarged when I got my LVAD.

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I need a heart pump implant due to severe heart failure not improved by medication.

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My heart failure is not caused by reduced blood flow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have needed dialysis in the last 3 months.

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I have a mechanical heart valve(s) implanted.

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My organs are failing and cannot recover.

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I cannot take blood thinners or have a bleeding disorder.

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My heart's left chamber is smaller than normal.

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I have had a heart or other organ transplant.

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I have had a stroke that now limits my ability to move and exercise.

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I have a heart condition known as hypertrophic obstructive cardiomyopathy or sarcoidosis.

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I am not part of any other studies involving heart failure treatments or devices.

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I have had more than one blood clot in my lungs or deep veins.

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I was born with a heart condition.

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I currently have an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of subjects that meet explantation criteria by month 12 post-LVAD implantation, have LVAD explanted and retain left ventricular ejection fraction >=45% at 12 months post-LVAD weaning

Secondary study objectives

Hospital Admissions

Six-minute Walk Test

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

After LVAD and wireless monitoring system (CardioMEMS) implantation, patients undergo cardiac rehab and pump speed will be optimized to maximize left ventricular unloading using CardioMEMS. During the Unloading phase, invasive hemodynamic guidance (via CardioMEMS) will be utilized to optimize pressure and volume unloading along with serial echocardiographic evaluations to assess for cardiac recovery, and LVAD explantation will be considered. After explantation, patients will undergo cardiac rehab and regular follow up with adjustments of HF medications based on the CardioMEMS-guided hemodynamic assessment.

Group II: ControlActive Control1 Intervention

After LVAD implantation, patients undergo cardiac rehab and pump speed will be optimized to maximize left ventricular unloading using echocardiographic imaging and other standard-of-care practices. During the Unloading phase, patients are serially evaluated with echocardiograms to assess for cardiac recovery, and LVAD explantation performed when predefined criteria are met. After explantation, patients undergo cardiac rehab and regular follow up.

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure include diuretics, which reduce fluid overload by increasing urine output; ACE inhibitors and ARBs, which lower blood pressure and reduce strain on the heart by inhibiting the renin-angiotensin-aldosterone system; beta-blockers, which slow the heart rate and decrease myocardial oxygen demand; and mineralocorticoid receptor antagonists, which help prevent fluid retention and reduce fibrosis. The CardioMEMS system specifically aids in heart failure management by providing real-time pulmonary artery pressure data, allowing for timely adjustments in therapy to prevent decompensation. This proactive approach can improve patient outcomes by reducing hospitalizations and managing symptoms more effectively.