Heart FailureNIME-CRTNCT05868616
Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
An observational study of Heart Failure and Pacemaker DDD, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Pacemaker DDD, Cardiomyopathies
- What is being tested?
- Cardiac Resynchronization Therapy (CRT)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 21 Mar 2023to Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for CRT implantation according to European Society of Cardiology (ESC) guidelines (2021) or postoperative control at Oslo University Hospital.
Who may be able to join
- 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.
Who cannot join
- Age < 18 years and > 80 years;
- Ongoing atrial fibrillation;
- Complete atrioventricular block
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0372
Espen W. Remme, Dr.ing, 004723071413, espen.remme@medisin.uio.no
Marit Witsø, MD, 004723071402, mhwitso@medisin.uio.no
About this study
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.
- Being tested
- Cardiac Resynchronization Therapy (CRT)
- Medical subject headings
- Heart Failure, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Implantation | Patients admitted for CRT implantation according to current ESC/AHA guidelines Receives: Device: Cardiac Resynchronization Therapy (CRT) | |
| Group 2 - 6 months control | Patients admitted for 6 months routine checkups of their CRT devices Receives: Device: Cardiac Resynchronization Therapy (CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reverse remodelling at 6 months follow-up
Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography
Measured: 6 months
Secondary outcomes (6)
Hospitalization
- all cause hospitalization
- heart failure hospitalization defined by symptom, signs and biochemistry (NT-proBNP)
Measured: 2 years
Mortality
- all cause death
- sudden cardiac death
- cardiovascular death
- transplantation
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start21 Mar 2023
- Primary completionMar 2028 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, Norwegian Health Association
- Responsible party
- Principal investigator, Espen Remme, Oslo University Hospital
- Investigators
- Espen W. Remme, Dr.ing, Study director, Oslo University HospitalMarit Witso, MD, Principal investigator, Oslo University HospitalHongxing Luo, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868616
- Sponsor's protocol ID
- 218564
- Acronym
- NIME-CRT
- Status last verified
- Oct 2026
- First submitted
- 26 Apr 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT05868616
- Acronym / sponsor ID
- NIME-CRT / 218564
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, Norwegian Health Association
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Implantation | – | Device: Cardiac Resynchronization Therapy (CRT)Patients admitted for CRT implantation according to current ESC/AHA guidelines |
| Group 2 - 6 months control | – | Device: Cardiac Resynchronization Therapy (CRT)Patients admitted for 6 months routine checkups of their CRT devices |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for CRT implantation according to European Society of Cardiology (ESC) guidelines (2021) or postoperative control at Oslo University Hospital.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (3 listed)
- Age < 18 years and > 80 years;
- Ongoing atrial fibrillation;
- Complete atrioventricular block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Group 1 - Implantation, Group 2 - 6 months control |
Primary outcome
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
6 secondary outcomes
Hospitalization
Time frame: 2 years
Mortality
Time frame: 2 years
New York Heart Association (NYHA) Functional Classification
Time frame: 2 years
Minnesota Living with Heart Failure Questionnaire
Time frame: 2 years
Packer clinical composite score
Time frame: 2 years
6 minute walk test
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Espen W. Remme, Dr.ing study director
Oslo University Hospital
Marit Witso, MD principal investigator
Oslo University Hospital
Hongxing Luo, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Pacemaker DDD, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Espen W. Remme, Dr.ing (004723071413, espen.remme@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reverse remodelling at 6 months follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.