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Status unknownNCT05151861REMOVEUpdated Dec 30, 2021

Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy:

A Phase 4 interventional study of Complete removal of pharmacological treatment and Control in Heart Failure, sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-30.

Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Phase 4, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this randomized trial is to investigate the effect of the complete removal of pharmacological treatment in patients responding to cardiac resynchronization therapy with recuperated LVEF in terms of imaging parameters (changes in LVEF and LV volume), as well as, clinical parameters that translate into worsening of heart failure.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia is the lead sponsor of 42 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient with a CRT device for at least one year due to the presence of LBBB and LVEF \<40% of non-ischemic origin
  2. Current LVEF ≥50% and normal volumes in two consecutive echocardiographic studies, separated at least 3 months, and the last one performed in the previous 6 months.
  3. Normally functioning CRT device with stimulation> 95%.
  4. NYHA functional class I-II.
  5. Absence of admissions for HF in the last year.
  6. NT-proBNP \<450pg/ml in sinus rhythm and \<900pg/ml in patients with atrial fibrillation, in the previous 6 months.
  7. Pharmacological treatment with beta-blockers, ACEIs/AIIRA/RNAI with or without MRA.
  8. Older than 18 years.
  9. Patients who have given their informed consent in writing.

Exclusion criteria

Exclusion Criteria:

  1. Previous episode of sustained ventricular tachycardia/recovered sudden death/appropriate shock (in the case of a patient with an implantable cardioverter-defibrillator associated with CRT).
  2. Uncontrolled arterial hypertension (figures> 140/90 mmHg).
  3. Need to use beta-blockers at the medical discretion for other indications such as heart rate (HR) control in atrial fibrillation (in the absence of ablation of the atrioventricular node) or to control other supra or ventricular arrhythmias.
  4. Severe valve disease.
  5. Diabetic or hypertensive with microalbuminuria or proteinuria.
  6. Renal failure with creatinine clearance \<30ml/min/1.73m2.
  7. Fertile women who are neither using contraceptives nor surgically sterilized; pregnant or lactating women.
  8. Patients are currently participating in a clinical trial or have participated in the past 30 days.
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Experimental

    Complete removal of pharmacological treatment

    Other: Complete removal of pharmacological treatment

  • Active comparator
    Control

    Maintenance of pharmacological treatment

    Drug: Control

Interventions

  • OtherComplete removal of pharmacological treatment

    Removal of treatment

  • DrugControl

    Maintenance of pharmacological treatment

06

What researchers measure

Primary outcomes

  1. 1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10%

    Number of patients with echocardiographic studies

    Time frame: Up to 48 weeks

  2. 2. An increase >15% in the VTSVIi (The end-systolic volume of the indexed left ventricle) to the previous one and in a range higher than the normal value

    Number of patients with echocardiographic studies

    Time frame: Up to 48 weeks

  3. 3. Clinical evidence of HF (Heart Failure) based on a global assessment, both clinical and analytical, together with the need to increase the dose of diuretics, as adjudicated by the research team.

    Number of patients with echocardiographic studies

    Time frame: Up to 48 weeks

Secondary outcomes

  1. total mortality, (Number )

    Total Number

    Time frame: Up to 48 weeks

  2. Cardiovascular mortality,

    Total Number

    Time frame: Up to 48 weeks

  3. Unplanned hospital admission or emergency room visit for HF (Heart Failure)

    Total Number

    Time frame: Up to 48 weeks

  4. Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds).

    Total Number

    Time frame: Up to 48 weeks

  5. Changes with respect to baseline levels of BP (Blood pressure )

    Time frame: Up to 48 weeks

  6. Changes with respect to baseline levels of HR figures. (heart rate)

    Time frame: Up to 48 weeks

  7. Change from baseline LVEF

    Time frame: Up to 48 weeks

  8. Change from baseline left ventricular end-diastolic volume (VTDVIi)

    Time frame: Up to 48 weeks

  9. Change from baseline body surface indexed left atrium volume (VAIi)

    Time frame: Up to 48 weeks

  10. Changes from baseline in global longitudinal strain (GLS).GLS is a simple parameter that expresses longitudinal shortening as a percentage (change in length as a proportion to baseline length).

    Time frame: Up to 48 weeks

  11. Changes in the quality of life questionnaires according to The Minnesota Living with Heart Failure (MLHFQ) scales.

    The response options range from 0, which indicates unaffected HRQL, to 5, which indicates the maximum impact on HRQL.

    Time frame: Up to 48 weeks

  12. Changes in the quality of life questionnaires according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) scales.

    The KCCQ is a 23-item (15 question) self-administered questionnaire designed to quantify physical limitations, symptoms (frequency, severity and recent change over time), social limitations, self-efficacy, and quality of life.As described, all KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.

    Time frame: Up to 48 weeks

07

Study locations

1 of 1 sites recruiting
  • Hospital Clínico Universitario Virgen de la Arrixaca
    Murcia, 30120, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05151861
Lead sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Responsible party
Sponsor
First posted
Dec 9, 2021
Start date
Dec 3, 2021
Primary completion
Nov 15, 2022 (estimated)
Completion
May 15, 2023 (estimated)
Last update
Dec 30, 2021

Study contacts

Francisco José Pastor Pérez, MD
Contact
franpastor79@hotmail.com
968369500
Lola Serna Guirao
Contact
lola.serna@carm.es
Francisco José Pastor Pérez, MD
principal investigator · HCUVA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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