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Characterization of Heart Failure With Preserved Ejection Fraction

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ClinicalTrials.gov Identifier: NCT03197350
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.


Condition or disease Intervention/treatment Phase
Fibrosis Estimated by cMR Ant Biomarkers Diagnostic Test: cMR Biological: biomarker Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Characterization of Heart Failure With Preserved Ejection Fraction
Actual Study Start Date : December 4, 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: HFpEF

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

Diagnostic Test: cMR
cardiac MRI done to complete the diagnosis

Biological: biomarker
Biomarker correlation with cMR parameters Prognostic information

Active Comparator: Controls

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

Diagnostic Test: cMR
cardiac MRI done to complete the diagnosis

Biological: biomarker
Biomarker correlation with cMR parameters Prognostic information




Primary Outcome Measures :
  1. Prognosis with a follow up including HF hospitalizations and/or deaths. [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197350


Contacts
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Contact: clotilde roy 003227642816 clotilderoy23@gmail.com
Contact: Anne Catherine Pouleur 003227642816 anne-catherine.pouleur@uclouvain.be

Locations
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Belgium
Cliniques universitaires Saint Luc Recruiting
Brussels, Belgium
Contact: Clotilde Roy         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Anne Catherine Pouleur Cliniques universitaires Saint-Luc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03197350     History of Changes
Other Study ID Numbers: HFpEF
2012/23AVR/199 ( Other Identifier: CEHF )
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
heart failure with preserved ejection fraction
Imaging
Prognosis
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases