Overview

Systematic Withdrawal of Neurohumoral Blocker Therapy in Optimally Responding CRT Patients

Status:
Completed
Trial end date:
2019-02-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to demonstrate that in patients with recuperated/normalized left ventricular function, defined as an ejection fraction (EF) ≥ 50%, after implantation of cardiac resynchronization therapy, device treatment is sufficient and neurohumoral blocker therapy can safely be withdrawn
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hasselt University
Collaborator:
Ziekenhuis Oost-Limburg
Treatments:
Adrenergic beta-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Spironolactone
Criteria
Inclusion Criteria:

- ≥18 years

- CRT implantation

- based on class I recommendations of ESC (European society of CArdiology)
guidelines:

- Left bundle branch block (LBBB) with QRS duration >150 ms and left ventricular
ejection fraction (LVEF) ≤35% who remained NYHA functional class II, III and
ambulatory IV despite adequate medical treatment

- LBBB with QRS duration 120-150 ms and LVEF ≤ 35% who remain in NYHA functional
class II, III and ambulatory IV despite adequate medical treatment

- At the moment of inclusion: ≥ 6 months after implantation

- At the moment of inclusion: normalised LVEF (≥ 50%), LVIDD/BSA (left ventricular
internal diastolic diameter indexed to body surface area) ≤3.2 cm/m²(woman) en ≤3.1
cm/m² (men) or LVDV/BSA (left ventricular diastolic volume indexed to body surface
area) ≤75 ml/m² (women) or ≤75 ml/m² (men)

- euvolemic clinical state and functioning in NYHA class I

Exclusion Criteria:

- contraindication for withdrawal of ACE-I/ARB such as diabetic nephropathy and
proteinuria > 1g / 24 h

- severe ventricular arrythmia (sustained VT or ventricular fibrillation) occuring at
the time LV function was normalized

- ischemic cardiomyopathy with evidence of scarring (scarring on MRI or severe
hypokinesia/akinesia in >1 LV wall segment on echocardiography)

- known severe coronary atherosclerosis (stenosis ≥ 80%)