Back to resultsWithdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: (REMOVE)
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Complete removal of pharmacological treatment
Control
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patient with a CRT device for at least one year due to the presence of LBBB and LVEF <40% of non-ischemic origin
- 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.
- Normally functioning CRT device with stimulation> 95%.
- NYHA functional class I-II.
- Absence of admissions for HF in the last year.
- NT-proBNP <450pg/ml in sinus rhythm and <900pg/ml in patients with atrial fibrillation, in the previous 6 months.
- Pharmacological treatment with beta-blockers, ACEIs/AIIRA/RNAI with or without MRA.
- Older than 18 years.
- Patients who have given their informed consent in writing.
Exclusion Criteria:
- 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).
- Uncontrolled arterial hypertension (figures> 140/90 mmHg).
- 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.
- Severe valve disease.
- Diabetic or hypertensive with microalbuminuria or proteinuria.
- Renal failure with creatinine clearance <30ml/min/1.73m2.
- Fertile women who are neither using contraceptives nor surgically sterilized; pregnant or lactating women.
- Patients are currently participating in a clinical trial or have participated in the past 30 days.
Sites / Locations
- Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Complete removal of pharmacological treatment
Maintenance of pharmacological treatment
Outcomes
Primary Outcome Measures
1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10%
Number of patients with echocardiographic studies
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
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
Secondary Outcome Measures
total mortality, (Number )
Total Number
Cardiovascular mortality,
Total Number
Unplanned hospital admission or emergency room visit for HF (Heart Failure)
Total Number
Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds).
Total Number
Changes with respect to baseline levels of BP (Blood pressure )
Changes with respect to baseline levels of HR figures. (heart rate)
Change from baseline LVEF
Change from baseline left ventricular end-diastolic volume (VTDVIi)
Change from baseline body surface indexed left atrium volume (VAIi)
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).
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.
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.
Full Information
NCT ID
NCT05151861
First Posted
November 12, 2021
Last Updated
December 9, 2021
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT05151861
Brief Title
Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy:
Acronym
REMOVE
Official Title
Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: Open and Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Complete removal of pharmacological treatment
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Maintenance of pharmacological treatment
Intervention Type
Other
Intervention Name(s)
Complete removal of pharmacological treatment
Intervention Description
Removal of treatment
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
Maintenance of pharmacological treatment
Primary Outcome Measure Information:
Title
1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10%
Description
Number of patients with echocardiographic studies
Time Frame
Up to 48 weeks
Title
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
Description
Number of patients with echocardiographic studies
Time Frame
Up to 48 weeks
Title
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.
Description
Number of patients with echocardiographic studies
Time Frame
Up to 48 weeks
Secondary Outcome Measure Information:
Title
total mortality, (Number )
Description
Total Number
Time Frame
Up to 48 weeks
Title
Cardiovascular mortality,
Description
Total Number
Time Frame
Up to 48 weeks
Title
Unplanned hospital admission or emergency room visit for HF (Heart Failure)
Description
Total Number
Time Frame
Up to 48 weeks
Title
Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds).
Description
Total Number
Time Frame
Up to 48 weeks
Title
Changes with respect to baseline levels of BP (Blood pressure )
Time Frame
Up to 48 weeks
Title
Changes with respect to baseline levels of HR figures. (heart rate)
Time Frame
Up to 48 weeks
Title
Change from baseline LVEF
Time Frame
Up to 48 weeks
Title
Change from baseline left ventricular end-diastolic volume (VTDVIi)
Time Frame
Up to 48 weeks
Title
Change from baseline body surface indexed left atrium volume (VAIi)
Time Frame
Up to 48 weeks
Title
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
Title
Changes in the quality of life questionnaires according to The Minnesota Living with Heart Failure (MLHFQ) scales.
Description
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
Title
Changes in the quality of life questionnaires according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) scales.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with a CRT device for at least one year due to the presence of LBBB and LVEF <40% of non-ischemic origin
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.
Normally functioning CRT device with stimulation> 95%.
NYHA functional class I-II.
Absence of admissions for HF in the last year.
NT-proBNP <450pg/ml in sinus rhythm and <900pg/ml in patients with atrial fibrillation, in the previous 6 months.
Pharmacological treatment with beta-blockers, ACEIs/AIIRA/RNAI with or without MRA.
Older than 18 years.
Patients who have given their informed consent in writing.
Exclusion Criteria:
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).
Uncontrolled arterial hypertension (figures> 140/90 mmHg).
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.
Severe valve disease.
Diabetic or hypertensive with microalbuminuria or proteinuria.
Renal failure with creatinine clearance <30ml/min/1.73m2.
Fertile women who are neither using contraceptives nor surgically sterilized; pregnant or lactating women.
Patients are currently participating in a clinical trial or have participated in the past 30 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco José Pastor Pérez, MD
Phone
968369500
Email
franpastor79@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lola Serna Guirao
Email
lola.serna@carm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco José Pastor Pérez, MD
Organizational Affiliation
HCUVA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy:
We'll reach out to this number within 24 hrs