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NCT Number: NCT05868616

Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

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.

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Key information

Conditions

Heart Failure Cardiomyopathies Cardiovascular Diseases Heart Diseases Pacemaker Ddd

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Sinus rhythm.
  • New York Heart Association class II / III heart failure on diagnosis and on optimal medical therapy.
  • Left bundle branch block.
  • QRS duration ≥ 130 ms.
  • Left ventricular ejection fraction ≤ 40%.
  • Patients must have echocardiography examination before implantation
  • Informed consent obtained from the patient.

Exclusion criteria

  • Age < 18 years and > 80 years;
  • Ongoing atrial fibrillation;
  • Complete atrioventricular block

Treatment and study plan

Cardiac Resynchronization Therapy (CRT)

Device

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.

Primary outcomes

  1. Reverse remodelling at 6 months follow-up

    Time frame: 6 months

    Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography

Secondary outcomes

  1. Hospitalization

    Time frame: 2 years

    • all cause hospitalization
    • heart failure hospitalization defined by symptom, signs and biochemistry (NT-proBNP)

  2. Mortality

    Time frame: 2 years

    • all cause death
    • sudden cardiac death
    • cardiovascular death
    • transplantation

  3. New York Heart Association (NYHA) Functional Classification

    Time frame: 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.

  4. Minnesota Living with Heart Failure Questionnaire

    Time frame: 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.

  5. Packer clinical composite score

    Time frame: 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.

  6. 6 minute walk test

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Espen W. Remme, Dr.ing

CONTACT

[email protected]

004723071413

Marit Witsø, MD

CONTACT

[email protected]

004723071402

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Health Association
  • South-Eastern Norway Regional Health Authority

Registry information

Acronym: NIME-CRT

Important dates

Study start
2023
Primary completion
2027
Study completion
2031
First posted
May 22, 2023
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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