NCT06140914

Brief Summary

Heart failure is a common disease, affecting 2-3% of the population in the western world. About 30% of patients with heart failure and reduced ejection fraction display signs of electrical dyssynchrony on ECG, usually left bundle branch block (LBBB), which is associated with a worse prognosis. Cardiac resynchronization therapy (CRT) reduce mortality for patients with dyssynchronic heart failure, defined as ejection fraction (EF) = or \< 35% and LBBB. About 1/3 of the patients that fit CRT criteria will not respond to CRT. Which patients that will turn out to be non-responders cannot be anticipated beforehand. We have started a clinical study to collect blood samples, heart tissue and clinical data from heart failure patients eligible for CRT and a control group of heart failure patients on medical therapy. Patients will be assessed before CRT implantation or early after initiation of medical treatment, at 3 months, 6 months and 12 months. Blood samples and tissue will be analysed in the search for (i) biomarkers to separate CRT responders from non-responders and (ii) mechanisms behind the remodelling observed in CRT and with medical therapy.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

November 14, 2023

Last Update Submit

November 14, 2023

Conditions

Heart FailureCardiac Remodeling, Ventricular

Keywords

ProteomicsmiRNAForce-calcium study

Outcome Measures

Primary Outcomes (1)

  • Biomarkers

    Proteins or exosomal miRNA from blood to separate CRT responders from non-responders

    2023-2028

Secondary Outcomes (1)

  • Endothelial function

    2023-2028

Other Outcomes (1)

  • Mechanism behind the reverse remodelling in CRT responders and with medical treatment

    2023-2028

Study Arms (2)

CRT

Heart failure patients that receive a CRT

Diagnostic Test: Proteomics, miRNA studies and studies of blood cells from blood samples

Control

Heart failure patients treated with medicines, without a CRT indication.

Diagnostic Test: Proteomics, miRNA studies and studies of blood cells from blood samples

Interventions

Proteomics, miRNA studies and studies of blood cells from blood samplesDIAGNOSTIC_TEST

This is an observational study where we follow patients and save blood samples and biopsies for analysis as described above.

Also known as: Force-calcium study from biopsy
CRTControl

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients followed at the Karolinska University Hospital in Stockholm, Sweden.

You may qualify if:

  • Ejection fraction (EF) = or \< 35% and A or B
  • A) Left bundle branch block (LBBB) QRS = or \> 150 ms or a high proportion ventricular pacing and planned for CRT at Karolinska University Hospital.
  • B) Planned for medical treatment and followed at Karolinska University Hospital.
  • Ability to understand the given information.
  • Ability to give informed consent.

You may not qualify if:

  • Pregnant or planning pregnancy
  • Not able to give informed consent -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Universitetssjukhuset

Stockholm, 171 76, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Heart biopsy

MeSH Terms

Conditions

Heart FailureVentricular Remodeling

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Marcus Ståhlberg, PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Ljung, PhD

CONTACT

0046739128078karin.a.ljung@regionstockholm.se

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 21, 2023

Study Start

March 15, 2023

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)