Clinical Characteristics and Predictors of Adverse Outcomes in HFpEF

NCT06228807 | Completed DMC

• 1 other identifier: HFpEF-CCPO
• Study Type: observational
• Target: 584
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

risk predictors; mortality

Outcome Measures

Primary Outcomes (1)

• Composite Events

  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.

Study Arms (2)

HFpEF patients with metabolic abnormalities

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

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

Interventions

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

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 with metabolic abnormalities; HFpEF patients without metabolic abnormalities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Heart failure with preserved ejection fraction(HFpEF)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ya-Wei Xu: lead

MeSH Terms

Interventions

Health Records, Personal

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: March 9, 2015
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share