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

4. november 2022 opdateret af: University Health Network, Toronto

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Fase 4

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Andre navne:
  • Transthoracic or 2D Echocardiogram
  • Transesophageal Echocardiogram (TEE)
Eksperimentel: 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.
Medicin: 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.
Andre navne:
  • Transthoracic or 2D Echocardiogram
  • Transesophageal Echocardiogram (TEE)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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.
Pre-operative up to 6 months, Immediate Intra-operative Pre-myectomy, Immediate Intra-operative Post-myectomy and Post-operative up to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Health Network, Toronto

Efterforskere

  • Ledende efterforsker: Jacobo Moreno Garijo, MD, Sunnybrook Health Science Centre
  • Ledende efterforsker: Azad Mashari, MD, University Health Network, Toronto

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. marts 2023

Primær færdiggørelse (Forventet)

1. august 2024

Studieafslutning (Forventet)

1. november 2024

Datoer for studieregistrering

Først indsendt

11. august 2021

Først indsendt, der opfyldte QC-kriterier

24. august 2021

Først opslået (Faktiske)

27. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. november 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2022

Sidst verificeret

1. november 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 16-5412

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