The Effect of TASH in Patients With HOCM

Hypertrophic Obstructive Cardiomyopathy Clinical Trial

— Post-TASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04066777
• Other study ID #: 1-10-72-62-19
• Status: Completed
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2023
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Cardiology	Aarhus N	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Steen Hvitfeldt Poulsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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