Biorepository Studying the Relationship Between Biomarkers and Heart Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/9/2019 |
| Start Date: | April 7, 2016 |
| End Date: | October 7, 2021 |
| Contact: | Hanna Gaggin, MD |
| Email: | hgaggin@mgh.harvard.edu |
| Phone: | 617-726-2709 |
Preserved vs. Reduced Ejection Fraction Biomechanical Marker Registry for Ambulatory Heart Failure Patients (PREFER-HF)
This study aims to prospectively evaluate the relationship between serial measurement of
several biomarkers, such as insulin-like growth factor binding protein 7 (IGFBP7), bone
morphogenic protein 1 (BMP1), carboxyterminal propeptide of type-I procollagen (PICP), tissue
inhibitor of metalloproteinases 1 (TIMP1) and matrix metallopeptidase 9 (MMP9), and
echocardiographic features in three groups, including patients with heart failure with
preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF),
and patients without a history of heart failure (HF). The relationship between these
biomarkers and one year major adverse events will also be evaluated.
several biomarkers, such as insulin-like growth factor binding protein 7 (IGFBP7), bone
morphogenic protein 1 (BMP1), carboxyterminal propeptide of type-I procollagen (PICP), tissue
inhibitor of metalloproteinases 1 (TIMP1) and matrix metallopeptidase 9 (MMP9), and
echocardiographic features in three groups, including patients with heart failure with
preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF),
and patients without a history of heart failure (HF). The relationship between these
biomarkers and one year major adverse events will also be evaluated.
All ambulatory patients, 18 years and older, with a history of HF, meeting all of the
inclusion criteria and none of the exclusion criteria will be eligible. Age and sex matched
patients with no history of HF will also be considered eligible.
The investigators will compare baseline biomarker concentrations across the three groups of
patients (i.e. HFpEF, HFrEF, and no history of HF) as well as across all study subjects.
Baseline measures will be compared against one-year follow up data for all variables
delineated and one-year major adverse events, with a composite endpoint of all-cause death
and hospitalization.
Additionally, we will examine genetic variants and their associations with HF subtypes. To
achieve this, we will relate single nucleotide polymorphisms (SNPs) associated with left
ventricular remodeling pathways to HF subtypes.
In a subgroup of patients for whom echocardiography is available, we will compare
echocardiographic measures across the three groups. When available, DICOM images of
transthoracic echocardiograms will be collected in order to collect precise measures of novel
and established dysfunction.
inclusion criteria and none of the exclusion criteria will be eligible. Age and sex matched
patients with no history of HF will also be considered eligible.
The investigators will compare baseline biomarker concentrations across the three groups of
patients (i.e. HFpEF, HFrEF, and no history of HF) as well as across all study subjects.
Baseline measures will be compared against one-year follow up data for all variables
delineated and one-year major adverse events, with a composite endpoint of all-cause death
and hospitalization.
Additionally, we will examine genetic variants and their associations with HF subtypes. To
achieve this, we will relate single nucleotide polymorphisms (SNPs) associated with left
ventricular remodeling pathways to HF subtypes.
In a subgroup of patients for whom echocardiography is available, we will compare
echocardiographic measures across the three groups. When available, DICOM images of
transthoracic echocardiograms will be collected in order to collect precise measures of novel
and established dysfunction.
Inclusion criteria for patients with HFpEF:
- Left ventricular ejection fraction (LVEF) > 50% and
- History of clinical symptoms consistent with HF and at least one of the following
supporting evidence of HF:
- NT-proBNP > 125 pg/mL
- BNP > 35 pg/mL
- Capillary wedge pressure >15 mmHg on right heart catheterization
- LVEDP ≥ 15 mmHg
- Radiographic evidence of pulmonary edema
- Improvement in symptoms with diuretic initiation or increase
- CPET evidence of cardiac etiology of symptoms
Inclusion criteria for patients with HFrEF:
- Left ventricular ejection fraction (LVEF) < 50% and
- History of clinical symptoms consistent with HF and one of the following supporting
evidence of HF:
- NT-proBNP > 125 pg/mL
- BNP > 35 pg/mL
- Capillary wedge pressure > 15 mmHd on right heart catheterization
- LVEDP ≥ 15 mmHg
- Radiographic evidence of pulmonary edema
- Improvement in symptoms with diuretic initiation or increase
- CPET evidence of cardiac etiology of symptoms
Exclusion criteria (for all patients, including both those with HFpEF and HFrEF):
- End stage renal disease on dialysis
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Hanna Gaggin, MD
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