Status:
COMPLETED
Systematic Withdrawal of Neurohumoral Blocker Therapy in Optimally Responding CRT Patients
Lead Sponsor:
Hasselt University
Collaborating Sponsors:
Ziekenhuis Oost-Limburg
Conditions:
Heart Failure (HF)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- ≥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
- 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%)
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02200822
Start Date
July 1 2014
End Date
February 1 2019
Last Update
August 1 2019
Active Locations (1)
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1
Ziekenhuis Oost Limburg
Genk, Limburg, Belgium, 3600