Echocardiography for Aortic Valve Stenosis

Overseen By Jonathan Lindner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Must be taking: Antihypertensives

Disqualifiers: Severe valve disease, others

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

Compensation: Varies

Number of Visits: Unknown

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how certain blood factors and heart valve conditions contribute to the worsening of aortic stenosis (AS), a heart condition that affects blood flow and often requires surgery. Researchers are investigating whether these factors can serve as early warning signs and potential treatment targets to slow the disease. Participants will undergo advanced imaging tests to study these blood markers. The trial seeks individuals with mild to moderate AS who have had an echocardiogram showing specific heart valve conditions within the past three months. As an unphased trial, participants can contribute to groundbreaking research that could lead to new treatments for AS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that aggressive treatment of hypertension is beneficial, so you might need to continue any blood pressure medications.

What prior data suggests that this diagnostic test is safe?

Research indicates that this study aims to understand how certain blood elements, like von Willebrand factor (VWF) and platelet aggregation, affect the progression of aortic stenosis (AS), a heart condition. The study does not test a new drug or treatment but uses advanced imaging to examine heart valve function.

The tests involved, such as echocardiography (an ultrasound of the heart), are generally safe and non-invasive. These tests are commonly used in medical settings and typically do not cause serious side effects. They produce detailed images of the heart and help monitor the condition of the heart valves.

While no specific evidence of harm from these tests exists, discussing any concerns with the healthcare team involved in the study is always important. They can provide more detailed information about what to expect during the test and any possible risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on understanding the role of platelet adhesion in aortic stenosis (AS), a condition where the heart's aortic valve narrows. Unlike existing treatments that primarily aim to manage symptoms or replace the valve, this trial uses diagnostic tests to explore the underlying mechanisms contributing to AS. By comparing controls with patients having mild to moderate AS, the trial seeks to uncover new insights that could lead to innovative therapies. This approach could pave the way for more targeted and effective treatments in the future.

What evidence suggests that this diagnostic test is effective for aortic valve stenosis?

Studies have shown that echocardiography is essential for diagnosing and assessing aortic stenosis (AS). It provides clear images of the heart and its valves, aiding doctors in treatment decisions. Research indicates that echocardiography can reduce treatment delays, leading to better patient outcomes. It surpasses other methods in determining the severity of aortic valve disease. While it doesn't treat AS, it is crucial for understanding disease progression and guiding further treatment plans. Participants in this trial will be in either the "Mild to moderate AS" group, where echocardiography will assess their condition, or the "Controls" group, consisting of age and sex-matched individuals without AS as determined by echocardiography. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

Inclusion Criteria For AS group

Age >25 years of age

Age and sex-matched control subjects undergoing echocardiography with no aortic stenosis, and no more than mild severity disease of other valves.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants undergo advanced imaging and vascular biology studies to assess von Willebrand factor and platelet adhesion

4 years

Regular visits for imaging and blood tests

Follow-up

Participants are monitored for safety and effectiveness after the observation period

6 months

What Are the Treatments Tested in This Trial?

Interventions

• DiagnosticTest

How Is the Trial Designed?

Group I: Mild to moderate AS Experimental Treatment 1 Intervention

Patients with mild to moderate AS by echocardiography

Group II: Controls Experimental Treatment 1 Intervention

Age and sex match controls with no AS by echocardiography

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10417789/

Echocardiographic Evaluation of Aortic Stenosis - PMC - NIH

An early diagnosis is of utmost importance since it shortens treatment delays and improves patient outcomes. Echocardiography plays a key role ...

2.

asecho.org

asecho.org/wp-content/uploads/2017/04/2017ValveStenosisGuideline.pdf

2017ValveStenosisGuideline.pdf

Echocardiography is the key tool for the diagnosis and evaluation of aortic stenosis. Because clinical decision- making is based on the ...

3.

escardio.org

escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-18/the-value-of-echocardiography-in-aortic-valve-disease-an-in-depth-analysis

The value of echocardiography in aortic valve disease

However, sensitive risk stratification of aortic valve disease with tissue Doppler makes echocardiography superior compared to other methods.

4.

aafp.org

aafp.org/pubs/afp/issues/2008/0915/p717.html

Aortic Stenosis: Diagnosis and Treatment

Echocardiography is recommended in patients with classic symptoms of aortic stenosis accompanied by a systolic murmur and in asymptomatic ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S073510970202627X

Clinical efficacy of Doppler-echocardiographic indices ...

This study was designed to assess which hemodynamic index best accounts for clinical severity of aortic stenosis (AS) and to analyze the value of low-dose ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.124.036657

Clinical Outcomes According to Aortic Stenosis Management

Additionally, a recent meta‐analysis showed that patients with moderate AS had a higher risk of all‐cause death and lifetime loss compared with ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8201468/

Moderate Aortic Stenosis: What is it & When to Intervene?

It has been shown that clinical outcomes of patients with moderate AS are poor, highlighting the importance of detecting even mild degrees of ...

8.

mayoclinic.org

mayoclinic.org/diseases-conditions/aortic-stenosis/diagnosis-treatment/drc-20353145

Aortic valve stenosis - Diagnosis and treatment

This test uses several X-rays to create detailed images of the heart and heart valves. The test may be done to check the size of the aorta and ...

9.

aafp.org

aafp.org/pubs/afp/issues/2016/0301/p371.html

Aortic Stenosis: Diagnosis and Treatment

Aortic valve replacement is recommended for most symptomatic patients with evidence of significant aortic stenosis on echocardiography.

10.

sciencedirect.com

sciencedirect.com/science/article/pii/S1071916425003380

Impact of Mild and Moderate Aortic Stenosis in Acute Heart ...

The presence of mild or moderate aortic stenosis reflects an increased risk of mortality and admissions due to heart failure, indicating that ...