NCT04066777

The Effect of TASH in Patients With HOCM

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Steen Hvitfeldt Poulsen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hypertrophic Obstructive Cardiomyopathy

Interventions

Type	Name	Description
PROCEDURE	alcohol 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

Timeline

• Start date: 2019-05-29
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2019-08-26
• Last updated: 2023-11-18

Locations

1 site across 1 country: Denmark