Clinical Characteristics and Predictors of Adverse Outcomes in HFpEF

Y

Ya-Wei Xu

Status

Completed

Conditions

Heart Failure With Preserved Ejection Fraction

Treatments

Combination Product: The study involved a comparison of clinical characteristics, medical history, laboratory biomarkers, echocardiographic measurements, angiographic findings, and clinical outcomes between two groups.

Study type

Observational

Funder types

Other

Identifiers

NCT06228807
HFpEF-CCPO

Details and patient eligibility

About

Heart failure with preserved ejection fraction (HFpEF) is a prevalent form of heart failure characterized by impaired left ventricle pressures and diastolic dysfunction. Despite its increasing prevalence, effective treatment options for HFpEF remain limited, probably due to its heterogenous underlying pathological etiology involving chronic systemic inflammation and metabolic dysregulation. Identifying new predictors of poor prognosis is crucial for risk stratification and tailored management.

Full 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 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.

Enrollment

443 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

  • Age >18 years old;
  • Patients with serious hepatic and renal failure,
  • Non-cardiac causes of dyspnea, such as, asthma
  • Primary pulmonary hypertension.
  • Severe valvular heart disease.
  • Pericardial disease.
  • Coronary artery disease (stenosis>50).
  • History of myocardial infarction.

Trial design

443 participants in 2 patient groups

HFpEF patients with metabolic abnormalities
Treatment:
Combination Product: The study involved a comparison of clinical characteristics, medical history, laboratory biomarkers, echocardiographic measurements, angiographic findings, and clinical outcomes between two groups.
HFpEF patients without metabolic abnormalities
Treatment:
Combination Product: The study involved a comparison of clinical characteristics, medical history, laboratory biomarkers, echocardiographic measurements, angiographic findings, and clinical outcomes between two groups.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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