Is NCT07215715 recruiting in Boston, MA?

Yes, NCT07215715 is currently recruiting participants at its Boston, MA location. This hfpef - heart failure with preserved ejection fraction clinical trial is actively enrolling qualified participants.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HFpEF - Heart Failure With Preserved Ejection Fraction Clinical Trial in Boston, MA

Q: How do I join the hfpef - heart failure with preserved ejection fraction clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This HFpEF - Heart Failure With Preserved Ejection Fraction Study in Boston

The goal of this observational study is to measure shear wave velocity (SWV) in patients with non-reduced left ventricular ejection fraction (LVEF) heart failure and left ventricular hypertrophy, with or without transthyretin amyloidosis with cardiomyopathy (ATTR-CM), and in control subjects without heart failure or cardiomyopathy. The main question it aims to answer is: • Can SWV be used to measure myocardial and liver stiffness in the study's target populations? Researchers will compare patients with ATTR-CM, patients without ATTR-CM, and a control group to determine the distributions of SWV in each population. Participants will: * Have a standard cardiology assessment, including a physical exam, blood work, and an echocardiogram. * Undergo an investigational assessment with the eMyosound LYRA device to measure SWV in their myocardium and liver. * Have the investigational assessment repeated by a second observer to assess measurement reliability.

Sponsor: eMyosound SAS

Who Can Participate

Inclusion Criteria

Male or female age ≥ 60 years

Signed informed consent and able to comply with protocol Inclusion Criteria Common to the Heart Failure with non-reduced left ventricular ejection fraction (LVEF) with or without transthyretin amyloid cardiomyopathy (ATTR-CM) Arms:

Patients meeting the Universal Definition of Heart Failure \& HeartShare study criteria.

LVEF \>40% on the last available imaging study

Left ventricular hypertrophy (LVH) defined as left ventricular mass index (mass/BSA) in female \> 95 g/m², in male \> 115 g/m² according to American Society of Echocardiography/European Association of Cariology (ASE/EAC) guidelines42 OR as interventricular septum (IVS) thickness ≥12 mm Inclusion criterion specific to HF with non-reduced LVEF without ATTR-CM Arm:

Negative (grade 0) Pyrophosphate (PYP) scintigraphy within 24 months prior to the enrolment in the study OR Simple Score \<643 OR negative endomyocardial biopsy Inclusion criterion specific to HF with non-reduced LVEF with ATTR-CM Arm:

ATTR-CM objectively confirmed and classified at any time prior to the enrollment in the study, with monoclonal protein AL amyloidosis ruled out, according to American Heart Association (AHA) 2020 criteria Inclusion criteria in Control Subjects:

No diagnosis of HF or cardiomyopathy according to the universal definition of Heart Failure

No diagnosis of Transthyretin amyloid cardiomyopathy (ATTR-CM) or Amyloid light-chain (AL) amyloidosis

Exclusion Criteria

Pregnant OR pre-menopausal woman

Vulnerable patients

Acute Coronary Syndrome within 30 days

Heart rate greater than 130 beats/minute at the time of the measurements

Atrial fibrillation or flutter at the time of SWV measurement (history of AF is authorized provided they patient is in sinus rhythm at the time of the measurements)

Any clinically significant cardiac arrhythmia at the time of SWV measurement

Poor echogenicity preventing accurate ultrasound measurements

Patients with segmental wall motion abnormalities thought to be due to myocardial infarction.

Severe mitral or aortic valve disease (regurgitation or stenosis) excluded if the cause is other than ATTR (e.g., prolapse, endocarditis, prosthetic valve.)

Severe tricuspid valve disease (regurgitation or stenosis) excluded if the causes are other than ATTR.

Distance from skin to IVS ≥ 8 cm

Any prosthetic mechanical valve

Patients with mechanical cardiac assist devices other than pacemakers or defibrillators

Heart, lung, liver or kidney transplant history or expected in the next year

Severe renal impairment with eGFR \< 15 mL/min/1.73m² or end-stage renal disease or patient on dialysis.

Presence of any competing life-threatening risk over the next 12 months

Complicated uncontrolled diabetes mellitus HbA1c ≥9% with target organ damage.

Uncontrolled and persistent high-blood pressure with diastolic pressure \> 100 mmHg or systolic pressure \> 160 mmHg at the time of the measurement.

Acute decompensated state such as volume overload, etc. in the opinion of the study investigator

Skin abnormalities, infections, or open wounds at the site of the SVW measurement

Liver disease, at least moderate Exclusion criteria in both the HF with non-reduced LVEF with or without ATTR-CM Arms:

Known inherited cardiomyopathy, infiltrative cardiomyopathy (other than ATTR-CM for the study arm for ATTR-CM), cardiomyopathy from muscular dystrophies, cardiomyopathy with reversible causes (e.g., stress cardiomyopathy), hypertrophic cardiomyopathy or known pericardial constriction

History of treatment for ATTR-CM with Transthyretin (TTR) depleters Exclusion criteria Specific to Control Subjects:

Any diagnosis of cardiomyopathy or HF, whatever the cause46

LVH based on LV mass index female \>95 g/m², in male ≥115 g/m² OR IVS thickness ≥12 mm unless thought to be due to athlete's heart

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT07215715) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HFpEF - Heart Failure With Preserved Ejection Fraction Treatment Options in Boston, MA

If you're searching for hfpef - heart failure with preserved ejection fraction treatment options in Boston, MA, this clinical trial (NCT07215715) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hfpef - heart failure with preserved ejection fraction specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

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HFpEF - Heart Failure With Preserved Ejection Fraction Clinical Trial in Boston, MA

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