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Completed

NCT Number: NCT04066777

The Effect of TASH in Patients With HOCM

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Department of Cardiology

Aarhus N, Danmark, 8200, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

alcohol septal ablation

Procedure

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Pulmonary capillary wedge pressure (PCWP) at rest

    Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment

    Changes in PCWP at rest

  2. Peak oxygen uptake (VO2-max)

    Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment

    Changes in maximal oxygen consumption (L/min) measured during cardiopulmonary exercise test

  3. Work capacity

    Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment

    work capacity measured in watt during a cardiopulmonary exercise test

  4. LVOT gradient during maximum exercise

    Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment

    Changes of the LVOT gradient during maximum exercise, measured in mmHg during 2D echocardiography

  5. Coronary flow reserve

    Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment

    Changes in the ratio of maximum coronary blood flow (induced by infusion of adenosin) to resting coronary blood flow, estimated by 2D doppler echocardiography

  6. Changes in biomarkers

    Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment

    Changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) ng/l and troponin T ng/l

  7. Change in GLS (%) at peak exercise

    Time frame: Changes will be evaluated after an expected average of 6-9 months after treatment

    Change in global longitudinal strain (GLS) in % at peak exercise

  8. 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

    Changes of symptoms and quality of life with Kansas City Cardiomyopathy Questionnaire (KCCQ) assessed by clinical evaluation

Sponsors and collaborators

Lead sponsor

Steen Hvitfeldt Poulsen

Other

Registry information

Official study 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

Acronym: Post-TASH

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2019
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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