The Effect of TASH in Patients With HOCM (Post-TASH)
Primary Purpose
Hypertrophic Obstructive Cardiomyopathy
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
alcohol septal ablation
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrophic Obstructive Cardiomyopathy
Eligibility Criteria
Inclusion Criteria:
- LV 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.
Sites / Locations
- Aarhus University Hospital, Department of CardiologyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hypertrophic obstructive cardiomyopathy
Arm Description
injection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction
Outcomes
Primary Outcome Measures
Pulmonary capillary wedge pressure (PCWP) during exercise
Change in PCWP at 75 watt (or maximum exercise, if this is < 75 W)
Secondary Outcome Measures
Pulmonary capillary wedge pressure (PCWP) at rest
Changes in PCWP at rest
Peak oxygen uptake (VO2-max)
Changes in maximal oxygen consumption (L/min) measured during cardiopulmonary exercise test
Work capacity
work capacity measured in watt during a cardiopulmonary exercise test
LVOT gradient during maximum exercise
Changes of the LVOT gradient during maximum exercise, measured in mmHg during 2D echocardiography
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 in biomarkers
Changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) ng/l and troponin T ng/l
Change in GLS (%) at peak exercise
Change in global longitudinal strain (GLS) in % at peak exercise
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
Full Information
NCT ID
NCT04066777
First Posted
August 22, 2019
Last Updated
January 23, 2023
Sponsor
Steen Hvitfeldt Poulsen
1. Study Identification
Unique Protocol Identification Number
NCT04066777
Brief Title
The Effect of TASH in Patients With HOCM
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Steen Hvitfeldt Poulsen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Obstructive Cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective controlled study
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypertrophic obstructive cardiomyopathy
Arm Type
Other
Arm Description
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
Intervention Name(s)
alcohol septal ablation
Intervention Description
injection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction
Primary Outcome Measure Information:
Title
Pulmonary capillary wedge pressure (PCWP) during exercise
Description
Change in PCWP at 75 watt (or maximum exercise, if this is < 75 W)
Time Frame
Changes will be evaluated after an expected average of 6-9 months after treatment
Secondary Outcome Measure Information:
Title
Pulmonary capillary wedge pressure (PCWP) at rest
Description
Changes in PCWP at rest
Time Frame
Changes will be evaluated after an expected average of 6-9 months after treatment
Title
Peak oxygen uptake (VO2-max)
Description
Changes in maximal oxygen consumption (L/min) measured during cardiopulmonary exercise test
Time Frame
Changes will be evaluated after an expected average of 6-9 months after treatment
Title
Work capacity
Description
work capacity measured in watt during a cardiopulmonary exercise test
Time Frame
Changes will be evaluated after an expected average of 6-9 months after treatment
Title
LVOT gradient during maximum exercise
Description
Changes of the LVOT gradient during maximum exercise, measured in mmHg during 2D echocardiography
Time Frame
Changes will be evaluated after an expected average of 6-9 months after treatment
Title
Coronary flow reserve
Description
Changes in the ratio of maximum coronary blood flow (induced by infusion of adenosin) to resting coronary blood flow, estimated by 2D doppler echocardiography
Time Frame
Changes will be evaluated after an expected average of 6-9 months after treatment
Title
Changes in biomarkers
Description
Changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) ng/l and troponin T ng/l
Time Frame
Changes will be evaluated after an expected average of 6-9 months after treatment
Title
Change in GLS (%) at peak exercise
Description
Change in global longitudinal strain (GLS) in % at peak exercise
Time Frame
Changes will be evaluated after an expected average of 6-9 months after treatment
Title
Changes of symptoms and quality of life estimated by KCCQ
Description
Changes of symptoms and quality of life with Kansas City Cardiomyopathy Questionnaire (KCCQ) assessed by clinical evaluation
Time Frame
Changes will be evaluated after an expected average of 6-9 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Dybro, MD
Phone
+4526112115
Email
annedybr@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Steen Hvitfeldt Poulsen, DMSc
Phone
+4530922309
Email
steepoul@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steen Hvitfeldt Poulsen, DMSc
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Department of Cardiology
City
Aarhus N
State/Province
Danmark
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Dybro, MD
Phone
26112115
Email
annedybr@rm.dk
First Name & Middle Initial & Last Name & Degree
Steen Hvitfeldt Poulsen, DMSc
Phone
0045-30922309
Email
steepoul@rm.dk
First Name & Middle Initial & Last Name & Degree
Morten Kvistholm Jensen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Torsten Bloch Rasmussen, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
The Effect of TASH in Patients With HOCM
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