Clinical trial NCT06228807: Clinical Characteristics and Predictors of Adverse Outcomes in HFpEF
Official title: Exploring Clinical Characteristics and Predictors of Adverse Outcomes in Patients Diagnosed With Heart Failure With Preserve Ejection Fraction (HFpEF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: risk predictors
mortality
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Heart failure with preserved ejection fraction(HFpEF)

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Composite Events
timeFrame: From the time of hospital discharge until the event of specific outcome, death, or loss to follow up, maximum 10 years.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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