What side effects are associated with this type of intervention?

Common treatments for chronic heart failure include diuretics, ACE inhibitors, beta-blockers, and aldosterone antagonists. Diuretics can cause electrolyte imbalances and dehydration. ACE inhibitors may lead to cough, elevated blood potassium levels, and kidney dysfunction. Beta-blockers can cause fatigue, bradycardia, and worsening of asthma. Aldosterone antagonists may result in hyperkalemia and renal impairment. These side effects need to be carefully monitored, especially in a self-management setting.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Heart Failure that align with self-management and monitoring approaches. Notably, CardioMEMS HF System, an implantable device for PAP monitoring, has been approved to help manage heart failure by providing real-time data to optimize treatment. Additionally, medications such as beta-blockers (e.g., carvedilol), ACE inhibitors (e.g., enalapril), ARBs (e.g., losartan), and newer agents like ARNIs (e.g., sacubitril/valsartan) have been approved to improve heart function and reduce hospitalizations. These treatments, combined with advanced monitoring techniques, aim to enhance patient outcomes and reduce the burden of heart failure.

What other types of research exist?

Promising alternatives to Virtual Heart Failure Clinic with Pulmonary Artery Pressure Monitoring for chronic heart failure patients include: 1) Remote patient monitoring via non-invasive digital technologies, which have shown effectiveness in chronic disease management. 2) Telemedicine programs specifically designed for heart failure management, which can reduce hospital admissions and improve patient outcomes. 3) Implantable hemodynamic monitors, which have demonstrated potential in reducing heart failure hospitalizations and improving clinical outcomes. These alternatives leverage technology to provide continuous monitoring and timely interventions, potentially optimizing heart failure treatment and reducing adverse outcomes.

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Device

CardioMEMS Monitoring for Heart Failure (SELFIe-HF Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for Chronic Heart Failure (CHF) include diuretics, ACE inhibitors, beta-blockers, and aldosterone antagonists. Diuretics reduce fluid overload, decreasing pulmonary congestion and edema. ACE inhibitors and beta-blockers improve heart function by lowering blood pressure and heart rate, reducing the heart's workload. Aldosterone antagonists prevent fluid retention and reduce heart fibrosis. Pulmonary Artery Pressure (PAP) monitoring allows for real-time adjustments in these therapies, ensuring optimal dosing and timely intervention, which is crucial for preventing hospitalizations and improving quality of life in CHF patients.

N/A

Recruiting

Led By Anique Ducharme

Research Sponsored by Montreal Heart Institute

Eligibility Criteria Checklist

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

Must have

Anatomical criteria: PA branch diameter between 7 mm - 15 mm, For BMI >35, distance from patient's back to target PA<10cm

Symptomatic HF (NYHA III) with recent heart failure admission in the previous year (12 months)

Must not have

Persistent NYHA Class IV and ACC/AHA HF Stage D, patients implanted with a ventricular assist device (VAD), or patients listed for cardiac transplantation and likely to be transplanted within 12 months

History of pulmonary embolism or recurrent deep vein thrombosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a small device that monitors heart pressure and sends data to doctors remotely. It targets heart failure patients who have had hospitalizations. The goal is to see if this remote monitoring can reduce hospital visits and improve patient outcomes. A recently approved implantable wireless monitor has been shown to be effective in reducing hospitalizations among heart failure patients.

Who is the study for?

Adults over 18 with chronic heart failure, able to use a smartphone or iPad for self-management. They must have had a recent hospital visit for heart failure and meet specific criteria like PA branch diameter and NT-proBNP levels. Excluded are those with recent major cardiovascular events, severe conditions, certain medication intolerances, or who are pregnant.

What is being tested?

The trial is testing if managing heart failure through a virtual clinic using Pulmonary Artery Pressure monitoring leads to fewer hospital visits and better outcomes compared to standard care. It also evaluates the safety and cost-effectiveness of this approach in patients with different severities of heart failure.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from device implantation for PAP monitoring, possible infection risk at the site of implantation, allergic reactions to materials used in devices or medications prescribed during the trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

My pulmonary artery size and my body structure meet the specific requirements.

Select...

I have heart failure symptoms and was hospitalized for it in the last year.

Exclusion Criteria

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

Select...

I have severe heart failure, may have a heart pump, or am waiting for a heart transplant.

Select...

I have had a pulmonary embolism or recurrent deep vein thrombosis.

Select...

Criterion: You have unstable health conditions that make it difficult to monitor you from a distance or participate in the study. This could include very high or very low blood pressure, severe kidney disease, severe pulmonary hypertension, anemia, blood clotting issues, ongoing infections, pregnancy, or other serious health problems that could affect the study's evaluation.

Select...

I do not have severe heart valve issues, infections, or significant swelling around my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Number of Participants with cardiovascular (CV) death

Number of Participants with hospital admission for heart failure

Number of Participants with unplanned intravenous heart failure therapy in an outpatient clinic

+1 more

Secondary study objectives

Change in 6 minutes walk distance

Change in Quality of life

Change in functional capacity between baseline and 12-months

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: CardioMemsActive Control1 Intervention

The treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group.

Group II: ControlActive Control1 Intervention

Heart failure clinic follow up

0 / 6Eligibility 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 Chronic Heart Failure (CHF) include diuretics, ACE inhibitors, beta-blockers, and aldosterone antagonists. Diuretics reduce fluid overload, decreasing pulmonary congestion and edema. ACE inhibitors and beta-blockers improve heart function by lowering blood pressure and heart rate, reducing the heart's workload. Aldosterone antagonists prevent fluid retention and reduce heart fibrosis. Pulmonary Artery Pressure (PAP) monitoring allows for real-time adjustments in these therapies, ensuring optimal dosing and timely intervention, which is crucial for preventing hospitalizations and improving quality of life in CHF patients.

Implantable Hemodynamic Monitoring for Heart Failure Patients.Pulmonary hypertension related to congenital heart disease: a call for action.Let us use the pulmonary artery catheter correctly and only when we need it.