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| Name | Class |
|---|---|
| Ziekenhuis Oost-Limburg | OTHER |
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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of cardiac resynchronization therapy, device treatment is sufficient and neurohumoral blocker therapy can safely be withdrawn
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-intervention arm | No Intervention | continuation of neurohumoral blocker therapy based on maximum tolerated guideline recommended dose (this group is the control arm for as well withdrawal of beta blocker therapy as withdrawal of RAAS blocker therapy) | |
| withdrawal of beta blockers | Active Comparator | Intervention arm with systematic withdrawal of beta blocker therapy at a reverse sequence of guideline recommended uptitration. (this group is the experimental arm for beta blocker withdrawal. This group receives no intervention with regards to the withdrawal of RAAS blockade). Per 2 weeks:
|
|
| withdrawal of RAAS blockers | Active Comparator | intervention arm with systematic withdrawal of spironolactone followed by withdrawal of ACE-I/ARB at a reverse sequence of guideline recommended uptitration (this group receives no intervention regarding the withdrawal of beta blockers. This group is the experimental arm for withdrawal of RAAS blockers)
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beta blockers | Drug |
| ||
| RAAS blockers |
| Measure | Description | Time Frame |
|---|---|---|
| a > 15% increase in left ventricular end systolic volume | at 12 months |
| Measure | Description | 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| >15% increase in left ventricular end systolic volume | 6 and 24 months | |
| > 15% decrease in left ventricular ejection fraction | at 6, 12 and 24 months | |
| mean blood pressure change |
Inclusion Criteria:
≥18 years
CRT implantation
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:
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| Name | Affiliation | Role |
|---|---|---|
| Petra Nijst, MD | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost Limburg | Genk | Limburg | 3600 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32216911 | Derived | Nijst P, Martens P, Dauw J, Tang WHW, Bertrand PB, Penders J, Bruckers L, Voros G, Willems R, Vandervoort PM, Dupont M, Mullens W. Withdrawal of Neurohumoral Blockade After Cardiac Resynchronization Therapy. J Am Coll Cardiol. 2020 Mar 31;75(12):1426-1438. doi: 10.1016/j.jacc.2020.01.040. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
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| ID | Term |
|---|---|
| D000319 | Adrenergic beta-Antagonists |
| ID | Term |
|---|---|
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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| withdrawal of RAAS - and beta blockers |
| Active Comparator |
intervention arm with systematic withdrawal of spironolactone, secondly ACE-I/ARB and finally beta blockers. (this group is the experimental group for both study interventions (withdrawal of beta blockers and RAAS blockers)
|
|
| Drug |
RAAS blockers (combination of ACE-I/ARB and a mineralocorticoid receptor antagonist) |
|
| VO2 max change |
| at 12 months |
| 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 |
| heart rate variability | at 6, 12 and 24 months |
| urinary catecholamine concentration | 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 |
| 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 |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |