NCT04022330

Brief Summary

The working hypothesis is that cardiac macrophages specific for the compensated cardiac hypertrophic phase limit the progression toward the decompensated state of heart failure by promoting an inflammatory environment favouring cardiomyocyte survival and preservation of the pump function. The investigators will perform studies in human plasma and monos, cardiac tissues and macrophages to validate this hypothesis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

3.5 years

First QC Date

July 15, 2019

Last Update Submit

July 23, 2019

Conditions

Left Ventricular Hypertrophy

Keywords

Left Ventricular HypertrophyCardiac macrophages

Outcome Measures

Primary Outcomes (1)

  • Identification of the complete spectrum of expressed mRNA of cardiac tissue macrophages.

    This complete mRNA profile obtained in patients will be compared to the one found in preclinical studies in mice. The genes that are expressed during compensated cardiac hypertrophy in both human and mouse will be sorted out. The expression of the latter genes will be correlated to the cardiac pump function in order to select in the macrophage transcriptome potential markers of compensated cardiac hypertrophy. The presence of these specific macrophage markers will be investigated on frozen cardiac tissue sections by immune-histochemistry and by real time polymerase chain reaction (rtPCR).

    18 months from start date

Secondary Outcomes (3)

  • Identification of the complete transcriptome (including surface markers) of circulating monocytes from the blood collected for this project

    24 months from start date

  • Determination of the plasmatic factors in correlation with cardiac macrophage that may be specific for the compensated or decompensated state of left ventricular hypertrophy

    24 months from start date

  • mRNA of the circulating monocytes

    24 months from start date

Study Arms (1)

Blood sampling

OTHER
Other: Blood sampling

Interventions

Blood samplingOTHER

The blood sampling will be done just before surgery

Blood sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years
  • Patients affiliated to a social security regimen
  • Informed signed consent
  • Group 1 : compensated
  • Symptomatic patients with severe aortic valve stenosis associated with asymmetric septal hypertrophy or patients with hypertrophic obstructive cardiomyopathy (HOCM), with echocardiographic transvalvular gradient ≥ 40 mmHg associated with echocardiographic septal/posterior wall thickness ≥ 1.3 ejection fraction ≥ 50%, planned for aortic valve replacement with septal myomectomy or septal myomectomy for HOCM
  • Group 2 : transition • Symptomatic patients with severe aortic valve stenosis associated with asymmetric septal hypertrophy or patients with hypertrophic obstructive cardiomyopathy (HOCM), with echocardiographic transvalvular gradient ≥ 40 mmHg associated with echocardiographic septal/posterior wall thickness ≥ 1.3 ejection fraction \< 50%, planned for aortic valve replacement with septal myomectomy or septal myomectomy for HOCM
  • Group 3 : decompensated
  • End-stage heart failure on the waiting list for cardiac transplantation or undergoing ventricular assist device implantation as a bridge to transplantation

You may not qualify if:

  • Combined aortic valve replacement and coronary artery bypass grafting or mitral/tricuspid surgery
  • Emergency operation
  • Acute endocarditis
  • Patient unable to give his consent
  • Patient deprived of freedom or under legal protection (guardianship or curatorship)
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Reza TAVAKOLI, Dr

    Pitié-Salpêtrière Hospital (AP-HP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reza TAVAKOLI, Dr

CONTACT

07 69 89 40 52r.tavakoli@ican-institute.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 17, 2019

Study Start

October 15, 2019

Primary Completion

April 15, 2023

Study Completion

April 15, 2024

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

FR(1)