Clinical Characteristics and Predictors of Adverse Outcomes in HFpEF
Exploring Clinical Characteristics and Predictors of Adverse Outcomes in Patients Diagnosed With Heart Failure With Preserve Ejection Fraction (HFpEF)
Study Overview
Status
Detailed Description
The prognosis for HFpEF is concerning, marked by significant mortality and frequent hospital readmissions. The exact mechanisms underlying HFpEF remain unresolved. The clinical syndrome arises from intricate interactions among various risk factors, leading to organ dysfunction and clinical symptoms. Common co-morbidities, including atrial fibrillation, diabetes, chronic kidney disease, and obesity, may influence HFpEF pathophysiology. Recent discussions suggest an inflammatory-metabolic phenotype in HFpEF, characterized by heightened inflammatory biomarkers, insulin resistance, hyperglycemia, hyperlipidemia, microvascular endothelial and vascular dysfunction, atherosclerosis, consequently leading to significant myocardial damage. However, there is still a lack of clinical risk predictors associated with metabolic phenotype within HFpEF.
The aim of this study is to investigate the impact of parameters reflecting the metabolic phenotype, coronary microvascular dysfunction in HFpEF and establish their correlation with clinical outcomes. The objective is to identify novel predictors for adverse prognosis in HFpEF, potentially serving as targets for drug therapy. This research aims to pave the way for targeted drug interventions in cardiometabolic diseases, offering new avenues for therapeutic approaches.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients diagnosed with HFpEF; Diagnostic criteria for HFpEF
- Presence of heart failure signs/symptoms symptoms
- Preserved left ventricular ejection fraction (EF) ≥50%
- BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;
- At least one additional criteria: presence of cardiac functional and structural abnormalities or diastolic dysfunction.
Exclusion Criteria:
- LVEF lower than 50%
- Patients with serious hepatic and renal failure,
- Non-cardiac causes of dyspnea, such as, asthma
- Primary pulmonary hypertension.
- Severe valvular heart disease.
- Pericardial disease.
- Recent history of myocardial infarction.
- Coronary artery disease (stenosis>50).
- Reduced contrast opacification (for caIMR assessment).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
HFpEF patients with metabolic abnormalities
|
Differences in clinical characteristics, history, laboratory biomarkers, echocardiographic measurements, angiographic findings, coronary microvascular function using caIMR and clinical outcomes were assessed between the two groups to identify potential risk factors.
Subsequently, the incidence of clinical outcomes and mortality was compared.
Univariate logistic regression and multivariate logistic regression analyses, adjusted for significant risk factors, were conducted to identify independent predictive factors.
Finally, a Receiver Operating Characteristic (ROC) curve was generated, and the area under the curve was evaluated to assess the predictive accuracy of the regression model.
|
|
HFpEF patients without metabolic abnormalities
|
Differences in clinical characteristics, history, laboratory biomarkers, echocardiographic measurements, angiographic findings, coronary microvascular function using caIMR and clinical outcomes were assessed between the two groups to identify potential risk factors.
Subsequently, the incidence of clinical outcomes and mortality was compared.
Univariate logistic regression and multivariate logistic regression analyses, adjusted for significant risk factors, were conducted to identify independent predictive factors.
Finally, a Receiver Operating Characteristic (ROC) curve was generated, and the area under the curve was evaluated to assess the predictive accuracy of the regression model.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite Events
Time Frame: From the time of hospital discharge until the event of specific outcome, death, or loss to follow up, maximum 10 years.
|
The composite events include a composite of all-cause mortality (death due to any cause), cardiovascular mortality (death due to cardiac cause), and heart failure rehospitalization.
|
From the time of hospital discharge until the event of specific outcome, death, or loss to follow up, maximum 10 years.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HFpEF-CCPO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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