The Effect of TASH in Patients With HOCM

NCT ID: NCT04066777

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-29
• Study Completion Date: 2023-10-01

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).

Conditions

Hypertrophic Obstructive Cardiomyopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypertrophic obstructive cardiomyopathy

injection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction

Group Type: OTHER

alcohol septal ablation

Intervention Type: PROCEDURE

injection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steen Hvitfeldt Poulsen

OTHER

Sponsor Role: lead

Responsible Party

Steen Hvitfeldt Poulsen

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Steen Hvitfeldt Poulsen, DMSc

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital, Department of Cardiology

Aarhus N, Danmark, Denmark

Countries

Denmark

Other Identifiers

1-10-72-62-19

Identifier Type: -

Identifier Source: org_study_id