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OpenTrials
Completed

NCT Number: NCT02200822

Systematic Withdrawal of Neurohumoral Blocker Therapy in Optimally Responding CRT Patients

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of cardiac resynchronization therapy, device treatment is sufficient and neurohumoral blocker therapy can safely be withdrawn

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ziekenhuis Oost Limburg

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

beta blockers

Drug

RAAS blockers

Drug

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

Primary outcomes

  1. a > 15% increase in left ventricular end systolic volume

    Time frame: at 12 months

Secondary outcomes

  1. - Incidence of HF related hospitalizations defined as admission to hospital / presentation to emergency room with need for parental therapy

    Time frame: at 12 months

  2. All cause mortality

    Time frame: at 12 months

  3. VO2 max change

    Time frame: at 12 months

Other outcomes

  1. >15% increase in left ventricular end systolic volume

    Time frame: 6 and 24 months

  2. > 15% decrease in left ventricular ejection fraction

    Time frame: at 6, 12 and 24 months

  3. mean blood pressure change

    Time frame: at 6, 12 and 24 months

  4. HF symptoms change (dyspnea visual analogue scale (VAS), New York Heart Association (NYHA) class, questionnaire "Minnesota living with Heart Failure")

    Time frame: at 6, 12 and 24 months

  5. incidence of heart rhythm events (sustained ventricular tachycardia (VT), atrial fibrillation, ventricular fibrillation)

    Time frame: at 6, 12 and 24 months

  6. heart rate variability

    Time frame: at 6, 12 and 24 months

  7. urinary catecholamine concentration

    Time frame: at 6, 12 and 24 months

  8. change in myocardial contractility (force frequence relationship, left ventricular pre-ejection time, iso-volumetric contraction time, dP/dt)

    Time frame: at 6, 12 and 24 months

  9. change in diastolic filling pattern

    Time frame: at 6, 12 and 24 months

  10. plasma concentrations of plasma renin activity and aldosterone

    Time frame: at 6, 12 and 24 months

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Ziekenhuis Oost-Limburg

Registry information

Official study title

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

Acronym: STOP-CRT

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 25, 2014
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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