Systematic Withdrawal of Neurohumoral Blocker Therapy in Optimally Responding CRT Patients

Heart Failure (HF) Clinical Trial

— STOP-CRT  

Official title:

Systematic Withdrawal of Neurohumoral Blocker Therapy in Optimally Responding Patients to Cardiac Resynchronization Therapy: the STOP-CRT Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200822
• Other study ID #: ZOL-STOP-CRT
• Status: Completed
• Phase: Phase 4
• Start date: July 2014
• Est. completion date: February 2019

Study information

• Verified date: July 2019
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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of cardiac resynchronization therapy, device treatment is sufficient and neurohumoral blocker therapy can safely be withdrawn

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure (HF)

Intervention

Drug:
• beta blockers

• RAAS blockers
RAAS blockers (combination of ACE-I/ARB and a mineralocorticoid receptor antagonist)

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	>15% increase in left ventricular end systolic volume		6 and 24 months
Other	> 15% decrease in left ventricular ejection fraction		at 6, 12 and 24 months
Other	mean blood pressure change		at 6, 12 and 24 months
Other	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
Other	incidence of heart rhythm events (sustained ventricular tachycardia (VT), atrial fibrillation, ventricular fibrillation)		at 6, 12 and 24 months
Other	heart rate variability		at 6, 12 and 24 months
Other	urinary catecholamine concentration		at 6, 12 and 24 months
Other	change in myocardial contractility (force frequence relationship, left ventricular pre-ejection time, iso-volumetric contraction time, dP/dt)		at 6, 12 and 24 months
Other	change in diastolic filling pattern		at 6, 12 and 24 months
Other	plasma concentrations of plasma renin activity and aldosterone		at 6, 12 and 24 months
Primary	a > 15% increase in left ventricular end systolic volume		at 12 months
Secondary	- Incidence of HF related hospitalizations defined as admission to hospital / presentation to emergency room with need for parental therapy		at 12 months
Secondary	All cause mortality		at 12 months
Secondary	VO2 max change		at 12 months