Hypertrophic Obstructive CardiomyopathyPost-TASHNCT04066777
The Effect of TASH in Patients With HOCM
A study testing alcohol septal ablation in people with Hypertrophic Obstructive Cardiomyopathy, run by Steen Hvitfeldt Poulsen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy
- What is being tested?
- alcohol septal ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 29 May 2019to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Cardiology
Aarhus N, Danmark, 8200
About this study
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
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.
Read the 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
- Being tested
- alcohol septal ablation
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alcohol septal ablationProcedure or surgery
injection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction
| Study group | Role | What they receive |
|---|---|---|
| Hypertrophic obstructive cardiomyopathy | Other | injection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction Receives: Procedure: alcohol septal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary capillary wedge pressure (PCWP) during exercise
Change in PCWP at 75 watt (or maximum exercise, if this is < 75 W)
Measured: Changes will be evaluated after an expected average of 6-9 months after treatment
Secondary outcomes (8)
Pulmonary capillary wedge pressure (PCWP) at rest
Changes in PCWP at rest
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Changes will be evaluated after an expected average of 6-9 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start29 May 2019
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Obstructive CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective controlled study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steen Hvitfeldt Poulsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steen Hvitfeldt Poulsen, Aarhus University Hospital Skejby
- Investigators
- Steen Hvitfeldt Poulsen, DMSc, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066777
- Sponsor's protocol ID
- 1-10-72-62-19
- Acronym
- Post-TASH
- Status last verified
- Nov 2023
- First submitted
- 22 Aug 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04066777
- Acronym / sponsor ID
- Post-TASH / 1-10-72-62-19
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Steen Hvitfeldt PoulsenUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective controlled study
| Arm | Type | Receives |
|---|---|---|
| Hypertrophic obstructive cardiomyopathy | Other | Procedure: alcohol septal ablationinjection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alcohol septal ablationinjection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction | Procedure or surgery | Hypertrophic obstructive cardiomyopathy |
Primary outcome
Pulmonary capillary wedge pressure (PCWP) during exercise
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Change in PCWP at 75 watt (or maximum exercise, if this is < 75 W)
8 secondary outcomes
Pulmonary capillary wedge pressure (PCWP) at rest
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Peak oxygen uptake (VO2-max)
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Work capacity
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
LVOT gradient during maximum exercise
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Coronary flow reserve
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Changes in biomarkers
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Change in GLS (%) at peak exercise
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Changes of symptoms and quality of life estimated by KCCQ
Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Related trials for Hypertrophic Obstructive Cardiomyopathy
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
RecruitingObservational study
A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
Hypertrophic Cardiomyopathy
Not yet recruitingPhase 4
Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Nonobstructive Hypertrophic Cardiomyopathy
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
Active, not recruitingPhase 3
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steen Hvitfeldt Poulsen, DMSc principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alcohol septal ablation in people with Hypertrophic Obstructive Cardiomyopathy, run by Steen Hvitfeldt Poulsen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary capillary wedge pressure (PCWP) during exercise (time frame: Changes will be evaluated after an expected average of 6-9 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.