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

NCT03092843 | Completed

• 1 other identifier: 17-176
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Quality of Life Change in Patient Reported Outcomes

  1 year post myectomy

• Change in Quality of Life Change in Duke's Activity Status Index (DASI)

  1 year post myectomy

• Change in functional capacity post myectomy

  1 year post myectomy

Study Arms (2)

No functional capacity testing

6 minute walk Quality of life Questionaire

Functional Capacity Testing

6 minute walk Quality of Life Questionnaire Metabolic stress test

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-65 with an established diagnosis of obstructive hypertrophic cardiomyopathy and scheduled for septal Myectomy surgery

You may qualify if:

• Scheduled to undergo septal myectomy.
• Established diagnosis of obstructive HCM defined as:
• LVH Thickness ≥15mm left ventricular outflow tract gradient ≥50mmHg

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• 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.

  PMID: 39719417 DERIVED

• 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.

  PMID: 37302651 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Milind Desai, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: March 20, 2017
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)