Clinical Characteristics and Predictors of Adverse Outcomes in HFpEF

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, 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.

Enrollment: 584 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

• 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).

Trial design

584 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.