The Effect of TASH in Patients With HOCM (Post-TASH)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Obstructive Cardiomyopathy
• Intervention / Treatment: Procedure: alcohol septal ablation

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Danmark
    • Aarhus N, Danmark, Denmark, 8200
      • Aarhus University Hospital, Department of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary capillary wedge pressure (PCWP) during exercise	Change in PCWP at 75 watt (or maximum exercise, if this is < 75 W)	Changes will be evaluated after an expected average of 6-9 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary capillary wedge pressure (PCWP) at rest	Changes in PCWP at rest	Changes will be evaluated after an expected average of 6-9 months after treatment
Work capacity	work capacity measured in watt during a cardiopulmonary exercise test	Changes will be evaluated after an expected average of 6-9 months after treatment
LVOT gradient during maximum exercise	Changes of the LVOT gradient during maximum exercise, measured in mmHg during 2D echocardiography	Changes will be evaluated after an expected average of 6-9 months after treatment
Coronary flow reserve	Changes in the ratio of maximum coronary blood flow (induced by infusion of adenosin) to resting coronary blood flow, estimated by 2D doppler echocardiography	Changes will be evaluated after an expected average of 6-9 months after treatment
Change in GLS (%) at peak exercise	Change in global longitudinal strain (GLS) in % at peak exercise	Changes will be evaluated after an expected average of 6-9 months after treatment
Changes of symptoms and quality of life estimated by KCCQ	Changes of symptoms and quality of life with Kansas City Cardiomyopathy Questionnaire (KCCQ) assessed by clinical evaluation	Changes will be evaluated after an expected average of 6-9 months after treatment
Peak oxygen uptake (VO2-max)	Changes in maximal oxygen consumption (L/min) measured during cardiopulmonary exercise test	Changes will be evaluated after an expected average of 6-9 months after treatment
Changes in biomarkers	Changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) ng/l and troponin T ng/l	Changes will be evaluated after an expected average of 6-9 months after treatment

Collaborators and Investigators

• Sponsor: Steen Hvitfeldt Poulsen
• Investigators: Principal Investigator: Steen Hvitfeldt Poulsen, DMSc, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 1-10-72-62-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No