Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction (RASTA)

St. Antonius Hospital

Status: Unknown

Conditions: LVOTO - Left Ventricular Outflow Tract Obstruction; Remodeling, Ventricular; HOCM, Hypertrophic Obstructive Cardiomyopathy

Treatments: Procedure: PTSMA

Study type: Interventional

Funder types: Other

Identifiers

NCT04230551

RASTA_V6

Details and patient eligibility

About

Patients with HOCM and severe LVOT obstruction can remain asymptomatic while significant cellular and structural changes of the heart (adverse remodeling) may occur preceding heart failure and rhythm disorders. Hence, preventing adverse remodeling through LVOT desobstruction may have significant impact on cardiac function and geometry in this particular population, as it is in symptomatic patients.

The investigators will assess functional and structural characteristics of the myocardium in asymptomatic vs. symptomatic patients with severe LVOT obstruction before and after PTSMA, using advanced imaging studies with LGE-CMR and echocardiography.

Full description

The trial consists of three cohorts

1. Symptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (reference group)
2. Asymptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (study group)
3. Asymptomatic HOCM patients with severe LVOT obstruction with no intervention (observation group)

Enrollment: 15 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 40 yrs
• HOCM diagnosed by experienced cardiologists (European Society of Cardiology (ESC)-certified imaging cardiologists and/or finalized fellowship imaging)
• LVOT obstruction >30 mmHg pressure gradient in rest, or >50 mmHg during exercise by TTE and/or invasive measurement, performed experienced (imaging) cardiologists
• Symptomatic (NYHA class >2 or CCS class >2)
• Asymptomatic: free of any dyspnea/chest pain or discomfort associated with LVOT obstruction

Exclusion criteria

• LV wall thickness <15 mm
• Other conditions responsible for hypertrophy (e.g. hypertension, aortic valve disease)
• Moderate to severe mitral valve regurgitation
• Systolic anterior motion of the mitral valve
• Coronary artery disease requiring intervention
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

15 participants in 3 patient groups

Reference Group

Active Comparator group

Description:

Five symptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA

Treatment:

Procedure: PTSMA

Study Group

Experimental group

Description:

Five asymptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA

Treatment:

Procedure: PTSMA

Observation Group

No Intervention group

Description:

Five asymptomatic HOCM patients with severe LVOT obstruction will not undergo PTSMA