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Trial record 2 of 2 for:    amarone
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Surgical Septal Myectomy vs Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy (AMARONE)

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ClinicalTrials.gov Identifier: NCT04684290
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : September 16, 2021
Sponsor:
Collaborator:
Erasmus Medical Center
Information provided by (Responsible Party):
J.M. ten Berg, St. Antonius Hospital

Study Description
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Brief Summary:
The aim of this randomized trial is to compare the improvement in exercise capacity among patients with highly symptomatic hypertrophic obstructive cardiomyopathy despite optimal medical treatment who undergo alcohol septal ablation (ASA) or surgical septal myectomy (SSM).

Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Procedure: Alcohol Septal Ablation Procedure: Surgical Septal Myectomy Not Applicable

Detailed Description:
This is a prospective, multicentre, open label, randomized controlled, non-inferiority trial (RCT) with a 1:1 randomization to alcohol septal ablation or surgical septal myectomy in patients with hypertrophic obstructive cardiomyopathy (HOCM) between 40-75 year of age with symptoms and/or syncope due to HOCM despite medical therapy. A total of 100 patients will be included. All patients will be evaluated with bicycle ergometry exercise test, MRI and 2D-echo before and 1 year after invasive treatment. Follow-up will be at 1,3 and 5 years.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Septal Myectomy Versus Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy
Drug Information available for: Ethanol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Alcohol Septal Ablation Procedure: Alcohol Septal Ablation
Participants will be treated with alcohol septal ablation.
Active Comparator: Surgical Septal Myectomy Procedure: Surgical Septal Myectomy
Participants will be treated with surgical septal myectomy.


Outcome Measures
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Primary Outcome Measures :
  1. Metabolic Equivalent (METs) assessed with a bicycle ergometry exercise test [ Time Frame: 1 year after the invasive treatment ]
    The primary endpoint is the improvement of the exercise capacity in the form of Metabolic Equivalent (METs) which will be assessed with a bicycle ergometry exercise test (difference in exercise capacity in Metabolic Equivalents) performed before and 1 year after invasive treatment.


Secondary Outcome Measures :
  1. Number of participants with all-cause mortality [ Time Frame: Follow up will be 1,3 and 5 years ]
  2. Number of participants with cardiovascular mortality [ Time Frame: Follow up will be 1,3 and 5 years ]
  3. Number of participants with transient Ischemic Attack [ Time Frame: Follow up will be 1,3 and 5 years ]
  4. Number of participants with hospital Readmittance [ Time Frame: Follow up will be 1,3 and 5 years ]
  5. Number of participants with with occurrence of atrial fibrillation [ Time Frame: Follow up will be 1,3 and 5 years ]
  6. Number of participants with ventricular arrhythmias [ Time Frame: Follow up will be 1,3 and 5 years ]
  7. Number of participants with with complete heart block requiring permanent pacemaker implantation [ Time Frame: Follow up will be 1,3 and 5 years ]
  8. Number of participants with major bleeding [ Time Frame: First 30 days ]
    Bleeding rate will be analysed using Bleeding Academic Research Consortium (type 3,4 or 5), TIMI major and VARC major criteria.

  9. Number of participants with re-intervention [ Time Frame: Follow up will be 1,3 and 5 years ]
    One more time need for Alcohol septal ablation or surgical septal myectomy

  10. Blood sample results [ Time Frame: Follow up will be 1,3 and 5 years ]
    Troponin T (in ug/l)

  11. Blood sample results [ Time Frame: Follow up will be 1,3 and 5 years ]
    N-terminal prohormone of brain natriuretic peptide (NT-pro-BNP in pg/ml)

  12. Blood sample results [ Time Frame: Follow up will be 1,3 and 5 years ]
    Creatine-kinase (CK in U/l)

  13. Quality of life evaluation using the The Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Follow up will be 1,3 and 5 years ]
    In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. For brevity, only the performance characteristics of the overall summary score are presented in this discussion.

  14. Cardiac Magnetic Resonance Imaging (CMR) parameters [ Time Frame: Follow up will be 1,3 and 5 years ]
    Interventricular septal thickness (mm), atrial diameter (mm) , left and right ventricular diameter (mm), left ventricle end diastolic volume (ml), left ventricle systolic volume (ml)

  15. Cardiac Magnetic Resonance Imaging (CMR) parameters [ Time Frame: Follow up will be 1,3 and 5 years ]
    Left ventricle end diastolic volume (ml), left ventricle systolic volume (ml)

  16. Transthoracic echocardiogram [ Time Frame: Follow up will be 1,3 and 5 years ]
    Left ventricle ejection fraction (%)

  17. Transthoracic echocardiogram [ Time Frame: Follow up will be 1,3 and 5 years ]
    Left ventricle outflow tract gradient (mmHg)

  18. Transthoracic echocardiogram [ Time Frame: Follow up will be 1,3 and 5 years ]
    Left ventricular internal systolic and diastolic dimension (cm)

  19. Transthoracic echocardiogram [ Time Frame: Follow up will be 1,3 and 5 years ]
    Atrial diameter (ml/m2)

  20. Transthoracic echocardiogram [ Time Frame: Follow up will be 1,3 and 5 years ]
    Valvular function

  21. Transthoracic echocardiogram [ Time Frame: Follow up will be 1,3 and 5 years ]
    Right ventricular systolic pressure (mmHg)

  22. Transthoracic echocardiogram [ Time Frame: Follow up will be 1,3 and 5 years ]
    Interventricular septal thickness (mm)


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 40-75 years including 40 and 75 years of age
  2. HOCM eligible for both SSM and ASA by a heart team (multidisciplinary team) and core lab.
  3. Left ventricle outflow tract (LVOT) obstruction > 30mmHg at rest or during physiological provocation by transthoracic echocardiogram
  4. Symptomatic (New York Heart Association classification (NYHA) >1 or Canadian Cardiovascular Society (CCS) class >1) and/or syncope due to HOCM

Exclusion Criteria:

  1. Unable to give informed consent
  2. A life expectancy of less than 1 year
  3. Concomitant (structural valve disease, aorta, rhythm, CABG) surgery during the same session
  4. Not able to perform bicycle ergometry exercise test
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684290


Locations
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Netherlands
St. Antonius Hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 3435cm
Contact: Jurrien ten Berg    088 320 3000    j.ten.berg@antoniusziekenhuis.nl   
Sponsors and Collaborators
St. Antonius Hospital
Erasmus Medical Center
More Information
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Publications of Results:

Other Publications:
Gersh BJ, Maron BJ, Bonow RO, Dearani JA, Fifer MA, Link MS, Naidu SS, Nishimura RA, Ommen SR, Rakowski H, Seidman CE, Towbin JA, Udelson JE, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Failure Society of America; Heart Rhythm Society; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Dec 13;124(24):e783-831. doi: 10.1161/CIR.0b013e318223e2bd. Epub 2011 Nov 8. No abstract available.

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Responsible Party: J.M. ten Berg, Clinical Professor, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT04684290    
Other Study ID Numbers: NL73176.100.20
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
 Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases