Hypertrophic Obstructive Cardiomyopathy
Conditions
Brief summary
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.
Detailed description
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).
Interventions
PROCEDUREalcohol septal ablation
injection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction
Sponsors
Steen Hvitfeldt Poulsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Left ventricular wall thickness ≥ 15 mm in one or more myocardial segments that is not explained by loading conditions * LVOT gradients ≥ 30 mmHg at rest and/or ≥ 50 mmHg at Valsalva's maneuver or exercise * NYHA ≥ III
Exclusion criteria
* \< 18 years * Fertile women who do not use anti-contraceptives * Pregnancy * Patients are allowed to have a pacemaker (eg. an implantable cardioverter defibrillator (ICD)) but cannot be pace-dependent * Amiodarone treatment * Persistent or permanent atrial fibrillation/flutter * Previous SRT * Alcohol or drug abuse * Significant co-morbidity (judged by the investigator) * Patients who cannot give valid consent (e.g. mental illness or dementia) or who do not understand Danish.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary capillary wedge pressure (PCWP) during exercise | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak oxygen uptake (VO2-max) | 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 |
| Work capacity | Changes will be evaluated after an expected average of 6-9 months after treatment | work capacity measured in watt during a cardiopulmonary exercise test |
| LVOT gradient during maximum exercise | 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 |
| Pulmonary capillary wedge pressure (PCWP) at rest | Changes will be evaluated after an expected average of 6-9 months after treatment | Changes in PCWP at rest |
| Changes in biomarkers | 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 |
| Change in GLS (%) at peak exercise | Changes will be evaluated after an expected average of 6-9 months after treatment | Change in global longitudinal strain (GLS) in % at peak exercise |
| Changes of symptoms and quality of life estimated by KCCQ | 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 |
| Coronary flow reserve | 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 |
Countries
Denmark
Outcome results
None listed