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Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress Test

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ClinicalTrials.gov Identifier: NCT05025644
Recruitment Status : Not yet recruiting
First Posted : August 27, 2021
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE August 11, 2021
First Posted Date  ICMJE August 27, 2021
Last Update Posted Date November 8, 2022
Estimated Study Start Date  ICMJE March 2023
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2021)
Analyze if TEE immediate post-myectomy LVOT gradients, may be reproduced with provocation dobutamine test in HOCM patients, when compared to TTE LVOT gradients performed within 6 months post-myectomy, to prove septal myectomy efficacy. [ Time Frame: Pre-operative up to 6 months, Immediate Intra-operative Pre-myectomy, Immediate Intra-operative Post-myectomy and Post-operative up to 6 months ]
The preoperative gradients obtained by TTE, with and without stress test, within 6 months pre-myectomy, will be compared with the intraoperative TEE pre-myectomy gradients at baseline (before and after DBT stress test). The post-myectomy TEE gradients (before and after DBT stress test), will be compared with the follow up TTE gradients with and without stress test, performed within 6 months post-myectomy, to assess short term outcomes.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress Test
Official Title  ICMJE Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress Test
Brief Summary

The objectives of this study are to determine if the left ventricle outflow tract (LVOT) gradients may be reproduced with dobutamine (DBT) provocation test in obstructive HCM patients under general anesthesia and to analyze the change in anatomic LVOT area and pressure gradients (PG) before and after septal myectomy.

If the DBT stress test can reproduce preoperative gradients in HCM patients during septal myectomy surgery, surgeons will have the opportunity to assess the quality of the surgical procedure depending on the obtained gradients with DBT stress test after surgery when gradients can't be reproduced during general anesthesia after myectomy, and decide if further myectomy is required, saving a re-operation on the patient in the future.

Detailed Description

Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiomyopathy. Echocardiography is the noninvasive method of choice for the evaluation of morphologic and functional abnormalities in HCM. It is of paramount importance to distinguish between obstructive or non-obstructive HCM, based on the presence or absence of left ventricle outflow tract (LVOT) gradient using continuous wave Doppler (CWD), under resting and/or provocable conditions. HCM can then be divided into three different subgroups. When the gradient at rest is ≥ 30 mmHg the HCM is considered obstructive (HOCM); when the gradient is <30 mmHg at rest but ≥ 30 mmHg with provocation, the HCM is considered latent obstructive, and finally, non-obstructive occurs when the gradient is < 30mmHg at rest or with provocation.

The gold standard technique to treat symptomatic HOCM is the surgical transaortic septal myectomy, when the resting gradient or the provocable gradient is ≥50 mmHg. Hemodynamic conditions may change and lead to worsening or improvement in LVOT obstruction during general anesthesia. LVOT gradients during surgery should be measured under reproducible conditions possibly mimicking preoperative hemodynamics.

Dobutamine is a well-known inotropic agent, capable to induce sub-aortic gradients in HOCM. The development of a dynamic LVOT gradient during this test is a pharmacological phenomenon with no clinical significance, not been associated with increased frequency of chest pain, shortness of breath or ischemic wall motion abnormalities, because obstruction resolves after termination of dobutamine (DBT) infusion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a monocentric Phase IV prospective study that will be conducted on patients undergoing surgical myectomy treatment for HOCM, at Toronto General Hospital, to assess if LVOT gradients may be reproduced with dobutamine provocation test in HOCM patients under general anesthesia.

The participants in the study will require a standard 2D echocardiography within 6 months pre and post-surgery. Intraoperatively, the patients will be divided into two groups, one with preoperative PG under anesthesia <50mmHg (Group A), and one with preoperative PG under anesthesia ≥ 50mmHg (Group B).

Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Hypertrophic Obstructive Cardiomyopathy
Intervention  ICMJE
  • Drug: Pre and post-CPB Drug: Dobutamine Hydrochloride
    • Pre-CPB provocation test with DBT stress test will be started (starting at 5 mcg/kg/min, increasing every 3 min, to 10, 15 and 20 mcg/kg/min) until a PG ≥ 50mmHg is achieved (DBT peak dose). The DBT peak dose (DBT-pd) will be recorded.
    • Post-CPB provocation test at the DBT-pd achieved preoperatively.
    Other Names:
    • Transthoracic or 2D Echocardiogram
    • Transesophageal Echocardiogram (TEE)
  • Drug: Post-CPB Drug: Dobutamine Hydrochloride
    • Pre-CPB no intervention will be required.
    • Post-CPB provocation test with DBT stress test will be started (starting at 5 mcg/kg/min, increasing every 3 min, to 10, 15 and 20 mcg/kg/min) or until postoperative provocable PG is >16 mmHg.
    Other Names:
    • Transthoracic or 2D Echocardiogram
    • Transesophageal Echocardiogram (TEE)
Study Arms  ICMJE
  • Experimental: Preoperative Transesophageal Echocardiogram (TEE) PG under anesthesia <50mmHg (Group A)
    • Pre-cardiopulmonary bypass (CPB) (pre-myectomy) echocardiographic parameters: PG under DBT stress test at 5, 10, 15 and 20 mcg/kg/min or until a PG ≥ 50mmHg is achieved, will be recorded.
    • Post-CPB (post-myectomy) echocardiographic parameters: PG at DBT peak dose (DBT-pd) will be recorded.

    If LVOT PG post myectomy are >16 mmHg, the surgeon will be advised, for surgical management considerations.

    Intervention: Drug: Pre and post-CPB Drug: Dobutamine Hydrochloride
  • Experimental: Preoperative PG under anesthesia ≥ 50mmHg (Group B)
    • Pre-cardiopulmonary bypass (CPB) (pre-myectomy) echocardiographic parameters: PG without DBT stress test will be recorded.
    • Post-CPB (post-myectomy) echocardiographic parameters: PG at 5, 10, 15, 20 mcg/kg/min DBT stress test or until the postoperative provocable PG is >16 mmHg will be recorded.
    Intervention: Drug: Post-CPB Drug: Dobutamine Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2024
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. HOCM refractory to medical treatment with symptoms like syncope, angina or NYHA functional classes III and IV, with a resting gradient or provocable gradient equal or greater than 50 mmHg, requiring surgical intervention.
  2. Absence of other cardiac or systemic diseases capable of producing hypertrophy.
  3. Sinus rhythm.

Exclusion Criteria:

  1. Patient refusal.
  2. Patient unable to give consent.
  3. TEE contraindication.
  4. Different rhythm than sinus.
  5. Other systemic diseases capable of producing hypertrophy.
  6. Severe Aortic or coronary artery pathology.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Azad Mashari, MD (416) 340-4800 ext 5164 azad.mashari@uhn.ca
Contact: Jo Carroll 416 340-4800 ext 3243 jo.carroll@uhn.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05025644
Other Study ID Numbers  ICMJE 16-5412
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Health Network, Toronto
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacobo Moreno Garijo, MD Sunnybrook Health Science Centre
Principal Investigator: Azad Mashari, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP