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NCT03092843 Clinical Trial

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

Hypertrophic Cardiomyopathy Clinical Trial

— SPIRIT-HCM  

Official title:
Functional Capacity and Quality of Life Following SePtal Myectomy in patIents With Obstructive hypeRtrophIc cardiomyopaThy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03092843
Other study ID # 17-176
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2017
Est. completion date March 30, 2023

Study information
Verified date August 2023
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 177
Est. completion date March 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Quality of Life Change in Summary Score Mild improvement in Quality of Life summary score (increase in 5 points) as measured by Kansas City Cardiomyopathy Questionnaire -KCCQ 1 year post myectomy
Secondary Change in Quality of Life Change in Patient Reported Outcomes Quality of Life as measured by The Patient-Reported Outcomes Measurement Information System (PROMIS) Questionnaire 1 year post myectomy
Secondary Change in Quality of Life Change in Duke's Activity Status Index (DASI) Quality of Life as measured by the Duke's Activity Status Index (DASI) Questionnaire 1 year post myectomy
Secondary Change in functional capacity post myectomy Functional capacity will be measured by 6 minute walk 1 year post myectomy
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