search
Back to results

Characterization of Heart Failure With Preserved Ejection Fraction

Primary Purpose

Fibrosis Estimated by cMR Ant Biomarkers

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
cMR
biomarker
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fibrosis Estimated by cMR Ant Biomarkers focused on measuring heart failure with preserved ejection fraction, Imaging, Prognosis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • We intend to recruit consecutive patients admitted for HFPEF in our institution during the next 4 years. Eligible patients include those with age ≥50 years, LVEF ≥45%, symptomatic HF, and either a hospitalization for HF within the prior year or an elevated natriuretic peptide level (BNP ≥100 pg/mL or NT-proBNP ≥360 pg/mL) within the 60 days before inclusion.

Exclusion Criteria:

  • Patients with uncontrolled hypertension, significant valvular disease or with known infiltrative or hypertrophic cardiomyopathy will be excluded.

Sites / Locations

  • Cliniques universitaires Saint LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HFpEF

Controls

Arm Description

We intend to recruit consecutive patients admitted for HFPEF in our institution during the next 4 years. Eligible patients include those with age ≥50 years, LVEF ≥45%, symptomatic HF, and either a hospitalization for HF within the prior year or an elevated natriuretic peptide level (BNP ≥100 pg/mL or NT-proBNP ≥360 pg/mL) within the 60 days before inclusion. Intervention: cMR

We plan to recruit 10 per decade of age. These subjects will allow us to evaluate the effects of age on the parameters of our study. They will have no risk factors, a normal ECG at rest and normal heart ultrasound and no abnormalities on a stress test. Intervention: cMR

Outcomes

Primary Outcome Measures

Prognosis with a follow up including HF hospitalizations and/or deaths.
A follow up will be done by the investigators. After that, they will determine if fibrosis estimated by cMR or biomarkers is a significant prognostic factor.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2017
Last Updated
July 12, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
search

1. Study Identification

Unique Protocol Identification Number
NCT03197350
Brief Title
Characterization of Heart Failure With Preserved Ejection Fraction
Official Title
Characterization of Heart Failure With Preserved Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2014 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goals of this research will be to define some of the mechanisms underlying the progression and complications of heart failure (HF) with preserved left ventricular ejection fraction (HFPEF) Aim 1: to evaluate the differences in cardiac structure, function and fibrosis markers through the spectrum of HF stages in order to deepen the understanding of the pathophysiology driving HF progression. Aim 2: to define the mechanisms by which HF risk factors, such as hypertension, diabetes, obesity, and renal insufficiency, interact with age to increase HF risk, and to evaluate the role of precipitating factors such as myocardial ischemia, atrial fibrillation in HFPEF. Aim 3: to determine prognostic factors in HFPEF patients, by following these patients over time. Accordingly the investigators will correlate baseline data (echocardiographic, MRI or biomarkers) with incident cardiovascular events and determine whether these measures provide incremental prognostic information beyond clinical characteristics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosis Estimated by cMR Ant Biomarkers
Keywords
heart failure with preserved ejection fraction, Imaging, Prognosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will compare two different groups: controles and HFpEF patients, in order to better understand pathophysiology in HF with preserved ejection fraction.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HFpEF
Arm Type
Active Comparator
Arm Description
We intend to recruit consecutive patients admitted for HFPEF in our institution during the next 4 years. Eligible patients include those with age ≥50 years, LVEF ≥45%, symptomatic HF, and either a hospitalization for HF within the prior year or an elevated natriuretic peptide level (BNP ≥100 pg/mL or NT-proBNP ≥360 pg/mL) within the 60 days before inclusion. Intervention: cMR
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
We plan to recruit 10 per decade of age. These subjects will allow us to evaluate the effects of age on the parameters of our study. They will have no risk factors, a normal ECG at rest and normal heart ultrasound and no abnormalities on a stress test. Intervention: cMR
Intervention Type
Diagnostic Test
Intervention Name(s)
cMR
Intervention Description
cardiac MRI done to complete the diagnosis
Intervention Type
Biological
Intervention Name(s)
biomarker
Intervention Description
Biomarker correlation with cMR parameters Prognostic information
Primary Outcome Measure Information:
Title
Prognosis with a follow up including HF hospitalizations and/or deaths.
Description
A follow up will be done by the investigators. After that, they will determine if fibrosis estimated by cMR or biomarkers is a significant prognostic factor.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: We intend to recruit consecutive patients admitted for HFPEF in our institution during the next 4 years. Eligible patients include those with age ≥50 years, LVEF ≥45%, symptomatic HF, and either a hospitalization for HF within the prior year or an elevated natriuretic peptide level (BNP ≥100 pg/mL or NT-proBNP ≥360 pg/mL) within the 60 days before inclusion. Exclusion Criteria: Patients with uncontrolled hypertension, significant valvular disease or with known infiltrative or hypertrophic cardiomyopathy will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
clotilde roy
Phone
003227642816
Email
clotilderoy23@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Catherine Pouleur
Phone
003227642816
Email
anne-catherine.pouleur@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Catherine Pouleur
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint Luc
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clotilde Roy

12. IPD Sharing Statement

Citations:
PubMed Identifier
30086783
Citation
Roy C, Slimani A, de Meester C, Amzulescu M, Pasquet A, Vancraeynest D, Beauloye C, Vanoverschelde JL, Gerber BL, Pouleur AC. Associations and prognostic significance of diffuse myocardial fibrosis by cardiovascular magnetic resonance in heart failure with preserved ejection fraction. J Cardiovasc Magn Reson. 2018 Aug 8;20(1):55. doi: 10.1186/s12968-018-0477-4.
Results Reference
derived

Learn more about this trial

Characterization of Heart Failure With Preserved Ejection Fraction

We'll reach out to this number within 24 hrs