Clinical trial NCT04093973: Bicycle Exercise Echocardiography to Assess Physiological Significance of Mitral Annular Calcification
Official title: Bicycle Exercise Echocardiography to Assess Physiological Significance of Mitral Annular Calcification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Annulus Calcification
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
Collaborators: name: Lantheus Medical Imaging
First posted: 2019-09-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No vulnerable or special populations will be recruited for this study. In particular, those unable to or unwilling to consent, not yet adults, pregnant women and prisoners will be excluded.

Brief summary: Many people develop calcium deposits in the heart as they get older. One of the common places for this to occur is the mitral annulus, the band of tissue that supports the mitral valve (one of four heart valves). The purpose of this study is to examine effects of these deposits (termed mitral annular calcification or "MAC") on a person's ability to perform exercise. The research team will use ultrasound of the heart (Doppler echocardiography) to study people with MAC while they exercise on a specially designed bicycle.

Detailed description: Mitral annular calcification (MAC) involves build-up of calcium in the mitral annulus, the fibro-muscular band which supports the mitral valve. The annulus aids in valve function, contracting in early systole (contraction phase) and bringing the valve leaflets together. In diastole (filling phase) it enlarges allowing blood to flow freely across the valve. Calcification stiffens the annulus and can extend onto the valve leaflets stiffening them. When severe, MAC impairs flow across the valve (mitral stenosis). This is characterized by a pressure gradient across the valve which can be detected by Doppler echocardiography (ultrasound).

Routine Doppler echocardiography is performed at rest when heart rates and flow across the mitral valve are low. Thus, even with severe MAC, there may only be a small pressure gradient present. However, with exercise these gradients can rise rapidly, leading to symptoms such as fatigue and shortness of breath.

MAC is associated with aging and is becoming more prevalent. Our hypothesis is that MAC is a common cause of shortness of breath with exertion. Further, the investigator believes this is under-appreciated because routine Doppler echocardiograms are done at rest. Therefore, the investigator will study adult subjects with moderate to severe MAC during bicycle exercise. Doppler echocardiography will be used to measure both the resting gradient across the mitral valve and changes with exercise. Symptoms will be measured by Borg Perceived Exertion scale.

If the research team is successful, the research team expects to demonstrate convincingly that this commonly encountered finding on Doppler echocardiography is an important cause of patient symptoms.

Eligibility criteria: Inclusion Criteria:

* At least moderate mitral annular calcification as judged by a previously published semi-quantitative echocardiographic score
* Over 18 years of age
* Able to use the semi-supine exercise bicycle
* Should be able to give informed consent.

Exclusion Criteria:

* Oxygen dependent lung or cardiac disease
* Moderate or greater aortic valvular disease
* Moderate or greater mitral regurgitation
* Reduced left ventricular ejection fraction, \<35%
* Any diagnosed coronary disease
* A resting mean gradient of ≥10 mmHg across the mitral valve.

Primary outcomes:
measure: Change in mean mitral valve gradient from baseline to peak exercise in patients with Mitral Annular Calcification compared to controls.
timeFrame: Procedure day
Secondary outcomes:
measure: Change in pulmonary artery systolic pressure from baseline to peak exercise in patients with Mitral Annular Calcification compared to controls.
timeFrame: Procedure day
measure: Borg Perceived Exertion Score at peak exercise in patients with Mitral Annular Calcification compared to controls.
timeFrame: Procedure day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Healthcare Network
name: Gregg S Pressman, MD
role: PRINCIPAL_INVESTIGATOR
References: