Hyp Obst Cardiomyopathy
Hypertrophic ObsructiveCardiomyopathy:Should the Mitral Valve be Addressed During Septal Myectomy?
1 other identifier
interventional
98
0 countries
N/A
Brief Summary
Hypertrophic Obstructive cardiomyopathy (HOCM) is the most common genetic cardiomyopathy, heterogeneous in phenotype and clinical course. The genotype-phenotype relationship and associated molecular mechanisms are still incompletely understood. In the HOCM milieu, increased energy cost of force production, impairing performance and mitochondrial function, may be associated to patients' genotype and/or phenotype
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedApril 1, 2020
March 1, 2020
2 years
March 5, 2020
March 30, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
LVOT obstruction degree in cm by Echocardiography
The degree of the LVOT obstruction as measured in cm by echocardiography .
3 months
Systolic anterior motion of mitral valve
The presence of systolic anterior motion of mitral valve as assessed by post-operative echocardiography.
3 months
Secondary Outcomes (3)
Post-Operative complictions
3 months
post-operative general condition
3 Months
Post-operative mortality
3 months
Study Arms (1)
septal myectomy alone versus septal myectomy
EXPERIMENTALThe aims of the present study is to: 1. Compare the results of adequate septal myectomy alone versus septal myectomy + mitral repair in patients with HOCM. 2. Effect of mitral repair on outcome of patients with systolic anterior motion that accompanies HOCM.
Interventions
The Septal myectomy is the preferred treatment of most patients with HOCM, and many studies have documented relief of symptoms and satisfactory late patient survival after relief of outflow tract gradients. valve repair or replacement may be necessary
Eligibility Criteria
You may qualify if:
- All patients that present with hypertrophic obstructive cardiomyopathy (HOCM) with mean pressure gradient\>50 mm Hg at rest or on provocation
- HOCM patients with severe mitral regurgitation.
- HOCM patients with New York Heart Association (NYHA) functional class II to IV despite optimal medical treatment consisting of -blocking agents, calcium channel blockers, or both.
You may not qualify if:
- Non-obstructive physiological characteristics.
- Previous MV surgery.
- Patient with intrinsic pathology of the mitral valve.
- Patients \<18 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
March 5, 2020
First Posted
April 1, 2020
Study Start
May 1, 2020
Primary Completion
May 1, 2022
Study Completion
June 1, 2022
Last Updated
April 1, 2020
Record last verified: 2020-03