Reversal of cardiomyopathy by suppression of frequent premature ventricular complexes - a prospective randomized clinical trial

Completed

• Conditions: 1) Premature ventricular complex induced cardiomyopathy 2) Heart failure due to ectopic heart beats; 10007521

• Registration Number: NL-OMON38290
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

- CMP (LVEF < 50%) without identifiable cause (idiopathic) or post-infarction, > 6 months.
- Optimal conventional heart failure therapy > 3 months.
- Frequent monomorphic PVCs on Holter monitoring.
* Frequent <= more than 15% of all QRS complexes are PVCs.
* Monomorphic <= more than 75% of PVCs have the same morphology.
- Greater than 18 years of age.
- Willing and capable of giving informed consent.

Exclusion Criteria

- Other causes of LV systolic dysfunction:
* Significant valvular disease
* Untreated hypertension (blood pressure > 140 mmHg)
* Primary CMP (HCM, ARVC, LVNC, myocarditis, stress, peripartum)
* Secondary CMP (infiltrative, storage, toxic, neuromuscular/neurological, autoimmune)
- Electrocardiographic PVC characteristics suggestive of a focal origin not accessible by percutaneous approach.
- Sustained supra-ventricular arrhythmia.
- Evidence of significant CAD (>70% stenosis of a coronary artery) on coronary angiogram (CAG) or coronary CT necessitating revascularization (PCI / CABG) in the foreseeable future.
- Signs of current myocardial ischemia on ECG (dynamic STT segments) or during exercise testing (significant ST segment depression/elevation).
- Myocardial infarction within the last 6 calender months prior to enrollment.
- PCI / CABG within the last 6 calender months prior to enrollment.
- Physical status not allowing electrophysiological study (e.g. pregnancy or severe peripheral artery disease)
- Presence of any disease, other than the patients cardiac disease, associated with a reduced likelihood of survival for the duration of the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Absolute change in cardiac function using the echocardiographic parameter: Left<br /><br>ventricular ejection fraction (LVEF), assessed by modified Simpsons* rule at<br /><br>baseline versus 6 months follow-up.</p><br>