Clinical trial NCT00821353: Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy
Official title: Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Hypertrophic Cardiomyopathy
Keywords: Atrial fibrillation
Hypertrophic cardiomyopathy
RF ablation
Antiarrhythmic drugs
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2009-01-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients with hypertrophic cardiomyopathy (HCM) and represents an important complication in the clinical course of the disease, with adverse long-term consequences on functional status and outcome.

Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is challenging because of the limited long-term efficacy and potentially hazardous side effects of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is successfully used in clinical practice. However, comparison of the efficacy and safety of these two therapeutic options has not been done up till now in randomized manner in this group of patients.

Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs. antiarrhythmic drug therapy in patients with HCM and AF.


Eligibility criteria: Inclusion Criteria:

* Patients with hypertrophic cardiomyopathy and paroxysmal or chronic atrial fibrillation

Exclusion Criteria:

* Severe hear failure (NYHA IV)
* Left ventricular ejection fraction \<0.30
* Left atrial diameter \>65 mm
* Age \> 70 years
* Contraindication to anticoagulation with warfarin
* Presence of a mechanical prosthetic valve
* Presence of left atrial thrombus on TEE or CT
* Woman currently pregnant
* Renal failure (GFR \< 30 ml/min)
* Hepatic failure
* Untreated hypothyroidism or hyperthyroidism
* LVOT gradient \> 50 mmHg

Primary outcomes:
measure: Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications.
timeFrame: 1 year
Secondary outcomes:
measure: Changes in total symptomatic and asymptomatic AF burden.
timeFrame: 1 year
measure: Incidence of complications.
timeFrame: 1 year
measure: Changes in left atrial diameter and left ventricular function.
timeFrame: 1 year
measure: Changes in level of Nt-pro-BNP.
timeFrame: 1 year
measure: Changes in symptom severity and quality of life.
timeFrame: 1 year
measure: Changes in exercise capacity assessed by cardiopulmonary exercise testing.
timeFrame: 1 year
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Cardiology
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Pawel Derejko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Lidia Chojnowska, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Lukasz Szumowski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Franciszek Walczak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: