Heart Failure (HF)
Conditions
Keywords
neurohumoral blocker therapy, renin-angiotensin-aldosterone system (RAAS), RAAS-blocker, beta blocker, spironolactone, angiotensin converting enzyme inhibitor (ACE-I), angiotensin receptor blocker (ARB), cardiac resynchronization therapy (CRT), heart failure, dyssynchrony, left bundle branch block
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of cardiac resynchronization therapy, device treatment is sufficient and neurohumoral blocker therapy can safely be withdrawn
Interventions
DRUGbeta blockers
DRUGRAAS blockers
RAAS blockers (combination of ACE-I/ARB and a mineralocorticoid receptor antagonist)
Sponsors
Ziekenhuis Oost-Limburg
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a > 15% increase in left ventricular end systolic volume | at 12 months |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence of HF related hospitalizations defined as admission to hospital / presentation to emergency room with need for parental therapy | at 12 months |
| All cause mortality | at 12 months |
| VO2 max change | at 12 months |
Other
| Measure | Time frame |
|---|---|
| > 15% decrease in left ventricular ejection fraction | at 6, 12 and 24 months |
| mean blood pressure change | at 6, 12 and 24 months |
| HF symptoms change (dyspnea visual analogue scale (VAS), New York Heart Association (NYHA) class, questionnaire Minnesota living with Heart Failure) | at 6, 12 and 24 months |
| incidence of heart rhythm events (sustained ventricular tachycardia (VT), atrial fibrillation, ventricular fibrillation) | at 6, 12 and 24 months |
| change in diastolic filling pattern | at 6, 12 and 24 months |
| plasma concentrations of plasma renin activity and aldosterone | at 6, 12 and 24 months |
| change in myocardial contractility (force frequence relationship, left ventricular pre-ejection time, iso-volumetric contraction time, dP/dt) | at 6, 12 and 24 months |
| heart rate variability | at 6, 12 and 24 months |
| urinary catecholamine concentration | at 6, 12 and 24 months |
| >15% increase in left ventricular end systolic volume | 6 and 24 months |
Countries
Belgium
Outcome results
None listed