Aarhus University Hospital, Department of Cardiology
Aarhus N, Danmark, 8200, Denmark
NCT Number: NCT04066777
To examine patients with hypertrophic obstructive cardiomyopathy (HOCM) before and after septal alcohol ablation, to investigate the effect of the treatment in regards to changes in myocardial function, perfusion, invasive hemodynamics and exercise tolerance.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Aarhus N, Danmark, 8200, Denmark
Patients with HOCM who develop symptoms of heart failure are treated initially with non-vasodilating ß-blockers or verapamil to decrease myocardial contractility and heart rate. A substantial part of patients remain symptomatic despite medical treatment. In these patients interventional or surgical treatments (septal reduction therapies (SRT)) to reduce left ventricular outflow tract obstruction (LVOTO) is considered in the presence of moderate to-severe symptoms (New York Heart Association - functional class (NYHA) III-IV) and/or recurrent exertional syncope and an LVOTO gradient ≥50 mm Hg. In some centers, invasive therapy is also considered in patients with mild symptoms (NYHA Class II) who have a resting or maximum provoked gradient of ≥50 mm Hg (with exercise or Valsalva's maneuver) and moderate-to-severe mitral valve regurgitation. Advanced treatment options are alcohol septal ablation (ASA) or surgical myectomy often combined with mitral valve reconstructive surgery. These treatments have similar outcomes in terms of gradient reduction, symptom improvement and exercise capacity
No previous trials have examined the effect of ASA in HOCM with respect to changes in central hemodynamics and myocardial performance during exercise.
24 HOCM patients will be examined prior to ASA, and approximately six-nine months after ASA.
The examination set-up consists of simultaneous 1) transthoracic echocardiography (TTE), 2) right heart catheterization (RHC) and 3) cardiopulmonary exercise test (CPX).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
injection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Change in PCWP at 75 watt (or maximum exercise, if this is < 75 W)
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Changes in PCWP at rest
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Changes in maximal oxygen consumption (L/min) measured during cardiopulmonary exercise test
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
work capacity measured in watt during a cardiopulmonary exercise test
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Changes of the LVOT gradient during maximum exercise, measured in mmHg during 2D echocardiography
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Changes in the ratio of maximum coronary blood flow (induced by infusion of adenosin) to resting coronary blood flow, estimated by 2D doppler echocardiography
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) ng/l and troponin T ng/l
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Change in global longitudinal strain (GLS) in % at peak exercise
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Changes of symptoms and quality of life with Kansas City Cardiomyopathy Questionnaire (KCCQ) assessed by clinical evaluation
Steen Hvitfeldt Poulsen
Other
The Effect of Alcohol Septal Ablation Therapy on Left Ventricular Function and Invasive Hemodynamics at Rest and During Exercise in Patients With Hypertrophic Obstructive Cardiomyopathy
Acronym: Post-TASH
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