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

NCT ID: NCT03092843

Last Updated: 2023-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

177 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-20

Study Completion Date

2023-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No functional capacity testing

6 minute walk Quality of life Questionaire

No interventions assigned to this group

Functional Capacity Testing

6 minute walk Quality of Life Questionnaire Metabolic stress test

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Milind Desai

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Milind Desai, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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Desai MY, Szpakowski N, Tower-Rader A, Bittel B, Fava A, Ospina S, Xu B, Thamilarasan M, Mentias A, Smedira NG, Popovic ZB. Echocardiographic Changes Following Surgical Myectomy in Severely Symptomatic Obstructive Hypertrophic Cardiomyopathy: Insights From the SPIRIT-HCM Study. J Am Heart Assoc. 2025 Jan 7;14(1):e037058. doi: 10.1161/JAHA.124.037058. Epub 2024 Dec 24.

Reference Type DERIVED
PMID: 39719417 (View on PubMed)

Tower-Rader A, Szpakowski N, Popovic ZB, Bittel B, Fava A, Ospina S, Xu B, Thamilarasan M, Mentias A, Smedira NG, Desai MY. Patient reported outcomes in obstructive hypertrophic cardiomyopathy undergoing myectomy: Results from SPIRIT-HCM study. Prog Cardiovasc Dis. 2023 Sep-Oct;80:66-73. doi: 10.1016/j.pcad.2023.06.001. Epub 2023 Jun 9.

Reference Type DERIVED
PMID: 37302651 (View on PubMed)

Other Identifiers

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17-176

Identifier Type: -

Identifier Source: org_study_id

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