Hypertrophic Obstructive Cardiomyopathy Clinical Trial
Official title:
Hypertrophic ObsructiveCardiomyopathy:Should the Mitral Valve be Addressed During Septal Myectomy?
NCT number | NCT04329689 |
Other study ID # | HHosp |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2020 |
Est. completion date | June 1, 2022 |
Verified date | March 2020 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Not yet recruiting |
Enrollment | 98 |
Est. completion date | June 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. All patients that present with hypertrophic obstructive cardiomyopathy (HOCM) with mean pressure gradient>50 mm Hg at rest or on provocation 2. HOCM patients with severe mitral regurgitation. 3. 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. Exclusion Criteria: b. Exclusion criteria: 1. Non-obstructive physiological characteristics. 2. Previous MV surgery. 3. Patient with intrinsic pathology of the mitral valve. 4. Patients <18 years. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LVOT obstruction degree in cm by Echocardiography | The degree of the LVOT obstruction as measured in cm by echocardiography . | 3 months | |
Primary | Systolic anterior motion of mitral valve | The presence of systolic anterior motion of mitral valve as assessed by post-operative echocardiography. | 3 months | |
Secondary | Post-Operative complictions | Post-operative assessment by echocardiography for complications such as mitral regurgitation. | 3 months | |
Secondary | post-operative general condition | Assessment of post-operative general condition in terms of NYHA Classification. | 3 Months | |
Secondary | Post-operative mortality | assessment of post-operative mortality rate | 3 months |
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