Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

Recruiting

• Conditions: Heart Failure; Pacemaker DDD; Cardiovascular Diseases; Cardiomyopathies; Heart Diseases
• Interventions: Device: Cardiac Resynchronization Therapy (CRT)

• Registration Number: NCT05868616
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-21
• Study First Submitted: 2023-04-26
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-18
• Last Update Submitted: 2023-05-18
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Primary Completion: 2025-03
• Study Completion: 2031-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2 - 6 months control	Cardiac Resynchronization Therapy (CRT)	Patients admitted for 6 months routine checkups of their CRT devices
Group 1 - Implantation	Cardiac Resynchronization Therapy (CRT)	Patients admitted for CRT implantation according to current ESC/AHA guidelines

Primary Outcome Measures

Name	Time	Method
Reverse remodelling at 6 months follow-up	6 months	Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography

Secondary Outcome Measures

Name	Time	Method
Hospitalization	2 years	* all cause hospitalization; * heart failure hospitalization defined by symptom, signs and biochemistry (NT-proBNP)
Mortality	2 years	* all cause death; * sudden cardiac death; * cardiovascular death; * transplantation
6 minute walk test	6 months	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.
Minnesota Living with Heart Failure Questionnaire	2 years	Minnesota living with heart failure questionnaire is a validated patient-oriented measure of the adverse effects of heart failure on a patient's life.
Packer clinical composite score	2 years	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.
New York Heart Association (NYHA) Functional Classification	2 years	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.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway