Heart FailurePhase 4REMOVENCT05151861
Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy:
A Phase 4 study testing Complete removal of pharmacological treatment in people with Heart Failure, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Complete removal of pharmacological treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 3 Dec 2021to 15 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lola Serna Guirao contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
About this study
Official title: Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: Open and Randomized Study
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.
- Conditions
- Heart Failure
- Being tested
- Complete removal of pharmacological treatment, Control
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete removal of pharmacological treatmentOther
Removal of treatment
ControlDrug
Maintenance of pharmacological treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Complete removal of pharmacological treatment Receives: Other: Complete removal of pharmacological treatment |
| Control | Active comparator | Maintenance of pharmacological treatment Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10%
Number of patients with echocardiographic studies
Measured: Up to 48 weeks
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
Measured: Up to 48 weeks
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
Measured: Up to 48 weeks
Secondary outcomes (12)
total mortality, (Number )
Total Number
Measured: Up to 48 weeks
Cardiovascular mortality,
Total Number
Measured: Up to 48 weeks
Unplanned hospital admission or emergency room visit for HF (Heart Failure)
Total Number
Measured: Up to 48 weeks
Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds).
Total Number
Measured: Up to 48 weeks
Changes with respect to baseline levels of BP (Blood pressure )
Measured: Up to 48 weeks
Changes with respect to baseline levels of HR figures. (heart rate)
Measured: Up to 48 weeks
Change from baseline LVEF
Measured: Up to 48 weeks
Change from baseline left ventricular end-diastolic volume (VTDVIi)
Measured: Up to 48 weeks
Change from baseline body surface indexed left atrium volume (VAIi)
Measured: Up to 48 weeks
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).
Measured: Up to 48 weeks
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.
Measured: Up to 48 weeks
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.
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start3 Dec 2021
- Primary completion15 Nov 2022 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco José Pastor Pérez, MD, Principal investigator, HCUVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151861
- Sponsor's protocol ID
- IMIB-RMV-2021-02
- Acronym
- REMOVE
- Status last verified
- Dec 2021
- First submitted
- 12 Nov 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pastor-Perez FJ, Garrido-Bravo IP, Penafiel-Verdu P, Fernandez-Villa N, Manzano-Fernandez S, Oliva-Sandoval MJ, Perez-Martinez MT, Caro-Martinez C, Hernandez-Vicente A, Pascual-Figal DA; clinical trial REMOVE researches. Withdrawal of drug therapy in responders to cardiac resynchronization therapy: rationale and design of the REMOVE trial. Rev Esp Cardiol (Engl Ed). 2024 Oct;77(10):851-858. doi: 10.1016/j.rec.2024.02.021. Epub 2024 May 1. English, Spanish.
PubMed 38701881
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: Open and Randomized Study
- ClinicalTrials.gov ID
- NCT05151861
- Acronym / sponsor ID
- REMOVE / IMIB-RMV-2021-02
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Complete removal of pharmacological treatmentComplete removal of pharmacological treatment |
| Control | Active comparator | Drug: ControlMaintenance of pharmacological treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete removal of pharmacological treatmentRemoval of treatment | Other | Experimental |
| ControlMaintenance of pharmacological treatment | Drug | Control |
Primary outcome
1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10%
Time frame: Up to 48 weeks
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
Time frame: Up to 48 weeks
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.
Time frame: Up to 48 weeks
Number of patients with echocardiographic studies
12 secondary outcomes
total mortality, (Number )
Time frame: Up to 48 weeks
Cardiovascular mortality,
Time frame: Up to 48 weeks
Unplanned hospital admission or emergency room visit for HF (Heart Failure)
Time frame: Up to 48 weeks
Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds).
Time frame: Up to 48 weeks
Changes with respect to baseline levels of BP (Blood pressure )
Time frame: Up to 48 weeks
Changes with respect to baseline levels of HR figures. (heart rate)
Time frame: Up to 48 weeks
Change from baseline LVEF
Time frame: Up to 48 weeks
Change from baseline left ventricular end-diastolic volume (VTDVIi)
Time frame: Up to 48 weeks
Change from baseline body surface indexed left atrium volume (VAIi)
Time frame: Up to 48 weeks
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
Changes in the quality of life questionnaires according to The Minnesota Living with Heart Failure (MLHFQ) scales.
Time frame: Up to 48 weeks
Changes in the quality of life questionnaires according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) scales.
Time frame: Up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Derived from this study: PubMed 38701881Pastor-Perez FJ, Garrido-Bravo IP, Penafiel-Verdu P, Fernandez-Villa N, Manzano-Fernandez S, Oliva-Sandoval MJ, Perez-Martinez MT, Caro-Martinez C, Hernandez-Vicente A, Pascual-Figal DA; clinical trial REMOVE researches. Withdrawal of drug therapy in responders to cardiac resynchronization therapy: rationale and design of the REMOVE trial. Rev Esp Cardiol (Engl Ed). 2024 Oct;77(10):851-858. doi: 10.1016/j.rec.2024.02.021. Epub 2024 May 1. English, Spanish.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lola Serna Guirao contact
Francisco José Pastor Pérez, MD principal investigator
HCUVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Complete removal of pharmacological treatment in people with Heart Failure, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco José Pastor Pérez, MD (968369500, franpastor79@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10% (time frame: Up to 48 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05151861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.