What side effects are associated with this type of intervention?

Common treatments for heart failure, such as ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists, have specific side effects. ACE inhibitors can cause cough, elevated potassium levels, and kidney dysfunction. Beta-blockers may lead to fatigue, slow heart rate, and low blood pressure. Diuretics can result in electrolyte imbalances and dehydration. Aldosterone antagonists might cause high potassium levels and renal impairment. These treatments are essential for managing heart failure symptoms and improving heart function, but careful monitoring for side effects is necessary.

What prior FDA approvals exist?

FDA-approved treatments for heart failure have included a range of medications and therapies aimed at improving heart function and managing symptoms. Key treatments include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, and mineralocorticoid receptor antagonists, which help reduce the workload on the heart and prevent disease progression. Additionally, neprilysin inhibitors combined with ARBs (e.g., sacubitril/valsartan) have been approved to enhance heart function. Biomarker-based approaches, such as NT-proBNP screening, are used to guide treatment decisions and monitor disease progression. Advanced imaging techniques, including echocardiograms, are also integral in diagnosing and managing heart failure, ensuring timely and appropriate therapeutic interventions.

What other types of research exist?

Promising novel alternatives to NT-proBNP screening and AI echocardiogram for early identification of heart failure risk include: 1) Multi-biomarker panels that combine several cardiac biomarkers for a more comprehensive risk assessment. 2) Advanced imaging techniques such as cardiac magnetic resonance imaging (MRI) with tissue characterization capabilities. 3) Wearable technology with continuous monitoring capabilities, such as smartwatches with integrated ECG and heart rate variability analysis. 4) Genomic and proteomic profiling to identify genetic predispositions and molecular markers associated with heart failure.

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Diagnostic Test

Multidisciplinary Screening for Heart Failure (MAPLE-CHF Trial)

N/A

Recruiting

Led By Serge LePage, MD

Research Sponsored by Cardiology Research UBC

Eligibility Criteria Checklist

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

Must have

Regular loop diuretic use for >30 days within 12 months prior to consent

Previous ischemic or embolic stroke

Must not have

Renal replacement therapy

Inability to give informed consent (e.g. due to significant cognitive impairment)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment to six months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a computer program to identify potential heart failure patients from medical records, followed by blood tests and AI heart imaging. It targets patients at risk of heart failure to catch the condition early. The process involves scanning records, testing blood for a specific marker, and using AI for detailed heart images if needed.

Who is the study for?

This trial is for adults over 40 with risk factors like coronary artery disease, diabetes, atrial fibrillation, stroke history, regular diuretic use, COPD, peripheral artery disease or chronic kidney disease. It's not for those who can't consent, already have heart failure diagnosis or are on renal replacement therapy.

What is being tested?

The study tests if a special algorithm to find heart failure signs in electronic health records plus additional screening (NT-proBNP blood test and AI echocardiogram) can detect heart failure earlier compared to usual care methods.

What are the potential side effects?

There may be minimal side effects related to the cardiovascular physical examination and drawing of blood. The NT-proBNP test is generally safe but might cause slight discomfort. Echocardiograms and electrocardiograms are non-invasive and typically don't have side effects.

Eligibility Criteria

Inclusion Criteria

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

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I have been using water pills regularly for over a month in the past year.

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I have had a stroke caused by a clot.

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I have had a heart attack or surgery/intervention for blocked heart arteries.

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I have ongoing or permanent irregular heartbeats.

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I have diabetes.

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I have chronic kidney disease with specific test results.

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I am over 40 years old.

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I have had surgery or a procedure for blocked arteries in my legs.

Exclusion Criteria

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

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I am on dialysis.

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I am able to understand and agree to the study's procedures and risks.

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I have been diagnosed with heart failure before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment to six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment to six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to six 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 HF hospitalizations

Number of outpatient HF visits

Number of participants diagnosed with heart failure (HF) according to the European Society of Cardiology 2021 HF guidelines

+1 more

Secondary study objectives

HF events in HFrEF

incidence of prescription for guideline recommended HF therapies in patients diagnosed with HFrEF

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: Investigational arm guided by NT-proBNP resultActive Control4 Interventions

NT-proBNP drawn and if level elevated (\>125 pg/ml) a study visit with artificial intelligence (AI) echocardiogram, electrocardiogram (ECG), and heart failure (HF) focused examination conducted

Group II: Routine care armActive Control1 Intervention

Participants will be remotely monitored for number of heart failure events

0 / 11Eligibility 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 ACE inhibitors, which relax blood vessels and reduce the heart's workload; beta-blockers, which slow the heart rate and lower blood pressure; and diuretics, which help remove excess fluid from the body. NT-proBNP screening is used to detect elevated levels of this biomarker, indicating heart failure, while AI echocardiograms provide detailed images of heart function for early detection. These treatments and diagnostic tools are essential for managing symptoms, improving quality of life, and reducing hospitalizations in heart failure patients.