Functional Capacity and Quality of Life Following Septal Myectomy in Patients With HCM

Completed

• Conditions: Hypertrophic Cardiomyopathy

• Registration Number: NCT03092843
• Lead Sponsor: The Cleveland Clinic

Brief Summary

Investigators aim to assess changes in exercise capacity and quality of life after septal myectomy in patient with hypertrophic cardiomyopathy.

Detailed Description

The objective of this study is to examine change in quality of life and functional capacity as respectively measured by, Quality of Life Questionnaires and six-minute walk test distance, following septal myectomy in patients with obstructive hypertrophic cardiomyopathy, as compared to prior to surgery.

Study Timeline

• Study Start: 2017-03-20
• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-28
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• Scheduled to undergo septal myectomy.
• Established diagnosis of obstructive HCM defined as:

LVH Thickness ≥15mm left ventricular outflow tract gradient ≥50mmHg

Exclusion Criteria

• Prior septal myectomy or alcohol septal ablation
• Prior myocardial infarction
• Uncontrolled arrhythmias including ventricular tachycardia and atrial fibrillation
• Uncontrolled hypertension
• Angiographically documented coronary stenosis >50%, if available at time of screening
• Inability to provide informed consent
• Inability to walk without assistive devices
• Peripheral artery disease with claudication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life Change in Summary Score	1 year post myectomy	Mild improvement in Quality of Life summary score (increase in 5 points) as measured by Kansas City Cardiomyopathy Questionnaire -KCCQ

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life Change in Patient Reported Outcomes	1 year post myectomy	Quality of Life as measured by The Patient-Reported Outcomes Measurement Information System (PROMIS) Questionnaire
Change in Quality of Life Change in Duke's Activity Status Index (DASI)	1 year post myectomy	Quality of Life as measured by the Duke's Activity Status Index (DASI) Questionnaire
Change in functional capacity post myectomy	1 year post myectomy	Functional capacity will be measured by 6 minute walk

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States