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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Complete removal of pharmacological treatment |
|
| Control | Active Comparator | Maintenance of pharmacological treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complete removal of pharmacological treatment | Other | Removal of treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10% | Number of patients with echocardiographic studies | 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 | 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 | Up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| total mortality, (Number ) | Total Number | Up to 48 weeks |
| Cardiovascular mortality, | Total Number | Up to 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisco José Pastor Pérez, MD | Contact | 968369500 | franpastor79@hotmail.com | |
| Lola Serna Guirao | Contact | lola.serna@carm.es |
| Name | Affiliation | Role |
|---|---|---|
| Francisco José Pastor Pérez, MD | HCUVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universitario Virgen de la Arrixaca | Recruiting | Murcia | 30120 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38701881 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Control |
| Drug |
Maintenance of pharmacological treatment |
|
| Unplanned hospital admission or emergency room visit for HF (Heart Failure) | Total Number | Up to 48 weeks |
| Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds). | Total Number | Up to 48 weeks |
| Changes with respect to baseline levels of BP (Blood pressure ) | Up to 48 weeks |
| Changes with respect to baseline levels of HR figures. (heart rate) | Up to 48 weeks |
| Change from baseline LVEF | Up to 48 weeks |
| Change from baseline left ventricular end-diastolic volume (VTDVIi) | Up to 48 weeks |
| Change from baseline body surface indexed left atrium volume (VAIi) | 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). | 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. | 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. | Up to 48 weeks |