Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

Heart Failure Clinical Trial

— NIME-CRT  

Official title:

Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868616
• Other study ID #: 218564
• Status: Recruiting
• Start date: March 21, 2023
• Est. completion date: March 2031

Study information

• Verified date: May 2023
• Source: Oslo University Hospital
• Contact: Espen W. Remme, Dr.ing
• Phone: 004723071413
• Email: espen.remme[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Left bundle branch block (LBBB) exists in about 25% of patients with congestive heart failure and is associated with worsened prognosis. Cardiac resynchronization therapy (CRT) has been one of the most important advancements in the past two decades for patients with LBBB heart failure. However, 30-40% of patients receiving a CRT do not benefit from it. In this study, the investigators will test a noninvasive device to evaluate acute effect of CRT during implantation and at follow-up CRT controls. In addition, echocardiography will be performed during CRT turned ON and OFF to visualize the changes in intraventricular flow and functional parameters of the heart.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2031
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients referred for CRT implantation or postoperative control at Oslo University Hospital based on the European Society of Cardiology (ESC) guidelines (2021), and criteria below:

1. Sinus rhythm.

2. New York Heart Association class II / III heart failure on diagnosis and on optimal medical therapy.

3. Left bundle branch block.

4. QRS duration = 130 ms.

5. Left ventricular ejection fraction = 40%.

6. Patients must have echocardiography examination before implantation

7. Informed consent obtained from the patient.

Exclusion Criteria:

1. Age < 18 years and > 80 years;

2. Ongoing atrial fibrillation;

3. Complete atrioventricular block

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiovascular Diseases
• Heart Diseases
• Heart Failure
• Pacemaker DDD

Intervention

Device:
• Cardiac Resynchronization Therapy (CRT)
Cardiac resynchronization therapy (CRT) is a modality of cardiac pacing used in patients with left ventricular (LV) systolic dysfunction and dyssynchronous ventricular activation that provides simultaneous or nearly simultaneous electrical activation of the LV and right ventricle (RV) via stimulation of the LV and RV (biventricular pacing) or LV alone.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Health Association, South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reverse remodelling at 6 months follow-up	Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography	6 months
Secondary	Hospitalization	all cause hospitalization; heart failure hospitalization defined by symptom, signs and biochemistry (NT-proBNP)	2 years
Secondary	Mortality	all cause death; sudden cardiac death; cardiovascular death; transplantation	2 years
Secondary	New York Heart Association (NYHA) Functional Classification	The New York Heart Association (NYHA) functional classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.	2 years
Secondary	Minnesota Living with Heart Failure Questionnaire	Minnesota living with heart failure questionnaire is a validated patient-oriented measure of the adverse effects of heart failure on a patient's life.	2 years
Secondary	Packer clinical composite score	The Packer clinical composite score classifies each patient into 1 of 3 categories (improved, worsened, unchanged), and is determined using clinical outcomes (hospitalizations, death, heart transplant), heart failure status, and patient symptoms (defined by a higher New York Heart Association (NYHA) functional classification and quality of life measured using the Minnesota Living With Heart Failure Questionnaire). Each endpoint will be assessed at 6, 12, 18, and 24 months.	2 years
Secondary	6 minute walk test	The 6 minute walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The test will be performed in group 1 before implantation and at 6 months control to evaluate response to intervention.	6 months