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

Heart Failure Clinical Trial

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Official title:

Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: Open and Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05151861
• Other study ID #: IMIB-RMV-2021-02
• Status: Recruiting
• Phase: Phase 4
• Start date: December 3, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: December 2021
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: Francisco José Pastor Pérez, MD
• Phone: 968369500
• Email: franpastor79[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 worsening of heart failure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 15, 2023
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Complete removal of pharmacological treatment
Removal of treatment

Drug:
• Control
Maintenance of pharmacological treatment

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10%	Number of patients with echocardiographic studies	Up to 48 weeks
Primary	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
Primary	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
Secondary	total mortality, (Number )	Total Number	Up to 48 weeks
Secondary	Cardiovascular mortality,	Total Number	Up to 48 weeks
Secondary	Unplanned hospital admission or emergency room visit for HF (Heart Failure)	Total Number	Up to 48 weeks
Secondary	Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds).	Total Number	Up to 48 weeks
Secondary	Changes with respect to baseline levels of BP (Blood pressure )		Up to 48 weeks
Secondary	Changes with respect to baseline levels of HR figures. (heart rate)		Up to 48 weeks
Secondary	Change from baseline LVEF		Up to 48 weeks
Secondary	Change from baseline left ventricular end-diastolic volume (VTDVIi)		Up to 48 weeks
Secondary	Change from baseline body surface indexed left atrium volume (VAIi)		Up to 48 weeks
Secondary	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
Secondary	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
Secondary	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