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Reverse remodeling after PTSMA in severe but ASympTomAtic LVOT obstruction - RASTA study

Reverse remodeling after PTSMA in severe but ASympTomAtic LVOT obstruction - RASTA study - RASTA study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49130
Enrollment
Unknown
Registered
2019-10-11
Start date
2020-01-08
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HOCM

Interventions

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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 - Asymptomatic: free of any dyspnea/chest pain or discomfort associated with LVOT obstruction

Exclusion criteria

Exclusion criteria: - LV wall thickness

Design outcomes

Primary

MeasureTime frame
1. Extracellular volume fraction 2. Global longitudinal strain (TTE) and deformation (CMR) 3. Left and right-sided pressure gradients (TTE) 4. 4D velocity mapping 5. LV wall thickness, volumes and function

Secondary

MeasureTime frame
New York Heart Association (NYHA) classification at 12 and 24 months

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)