Longitudinal Multimarker Risk Models for Very Elderly Patients With Heart Failure and Preserved Ejection Fraction

N/AActive Not RecruitingNCT05992558

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal184 enrolled

Overview

The goal of this observational study is to develop longitudinal multimarker risk models for decision support during the clinical follow-up of very elderly patients with heart failure and preserved ejection fraction (HFpEF). The main questions it aims to answer are: * Can advanced risk prediction models accurately estimate the prognosis of very elderly patients with HFpEF over a 1-year follow-up after a hospitalization for acute heart failure? * Do novel biomarkers, in addition to routine clinical variables and elderly-specific predictors, contribute to improved risk prediction for these patients? To this end, very elderly patients (aged 80 or older) who have HFpEF and were admitted for acute heart failure will be included. Clinical and biological data will be collected during their hospitalization and also during follow-up visits 30 and 90 days after discharge. There is no comparison group in this observational study.

Background: Very elderly patients with heart failure and preserved ejection fraction (HFpEF) are under-represented in risk prediction models, and the role of prognostic biomarkers in this population is unclear due to the presence of cumulative comorbidity burden. Risk prediction is a useful tool to support decision making across the clinical follow-up of very elderly HFpEF patients. Aim: To develop longitudinal prognostic models based on readily available clinical and biological variables, novel biomarkers and elderly-specific predictors to estimate prognosis over 1-year follow-up after a HF hospitalization in very elderly patients with HFpEF. Design: Observational, single-centre, prospective cohort study of very elderly patients (≥80 years old) with HFpEF consecutively admitted for acute HF. Main outcome: Composite of 1-year all-cause mortality and/or HF-hospitalization. Sample size: 184 patients. Follow-up time: 1 year. Predictors: Routine clinical variables (sociodemographic, medical history, physical examination, vital signs, laboratory tests, imaging, concomitant medication, quality of life and elderly-specific factors) and novel biomarkers will be longitudinally collected during index hospitalization, 30-day and 90-day post-discharge visits. Statistical analysis: Kaplan-meier survival analysis. Logistic and Cox proportional-hazards regression models, time-to-event models for repeated events, linear-mixed effects, joint models, LASSO and machine learning techniques will be used for model development.

Study Type

OBSERVATIONAL

Enrollment

Eligibility

Sex: ALLMin age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age ≥80 years; 2. diagnosis of HFpEF, requiring the 4 following conditions: b1) typical symptoms and/or signs of HF; b2) left ventricular ejection fraction (LVEF) ≥50%; b3) elevated levels of natriuretic peptides (NTproBNP ≥300 pg/mL or BNP ≥100 pg/mL in sinus rhythm; NT-proBNP ≥900 pg/mL or BNP ≥300 pg/mL in atrial fibrillation); and b4) at least one additional criterion: b4.1) relevant structural heart disease (left ventricular hypertrophy and/or left atrial enlargement), or 4.2) diastolic dysfunction; 3. hospitalization with a primary diagnosis of acute HF; and 4. giving informed consent. Exclusion Criteria: 1. any clinical condition, such as HF secondary to congenital heart disease and severe valve disease, severe renal (requiring dialysis) and liver disease, active malignant diseases, autoimmune diseases, other diseases resulting in \<1-year life expectancy or any other condition that, according to investigators' criteria, could significantly interfere with the study objectives; 2. any clinical or social condition that prevents clinical follow-up.

Outcomes

Primary Outcomes

Composite of 1-year all-cause mortality and/or HF-hospitalization

Combined outcome of all-cause mortality and/or readmission for acute heart failure during a 12-month follow-up period after index hospitalization

Time frame: 12 months

Secondary Outcomes

1-year HF-hospitalization

Readmission for acute heart failure during a 12-month follow-up period after index hospitalization

Time frame: 12 months

3-month HF-hospitalization

Readmission for acute heart failure during a 3-month follow-up period after index hospitalization

Time frame: 3 months

1-month HF-hospitalization

Readmission for acute heart failure during a 1-month follow-up period after index hospitalization

Time frame: 1 month

1-year all-cause hospitalization

All-cause readmission during a 12-month follow-up period after index hospitalization

Time frame: 12 months

3-month all-cause hospitalization

All-cause readmission during a 3-month follow-up period after index hospitalization

Time frame: 3 months

1-month all-cause hospitalization

All-cause readmission during a 1-month follow-up period after index hospitalization

Time frame: 1 month

1-year all-cause mortality

All-cause mortality during a 12-month follow-up period after index hospitalization

Time frame: 12 months

1-year cardiovascular mortality

Cardiovascular mortality during a 12-month follow-up period after index hospitalization

Time frame: 12 months

1-year urgent HF visits

Urgent or unscheduled visit with new or worsening symptoms of acute heart failure requiring initiation of intravenous diuretic or vasoactive agent or mechanical or surgical intervention, with no hospital admission, during a 12-month follow-up period after index hospitalization

Time frame: 12 months

3-month urgent HF visits

Urgent or unscheduled visit with new or worsening symptoms of acute heart failure requiring initiation of intravenous diuretic or vasoactive agent or mechanical or surgical intervention, with no hospital admission, during a 3-month follow-up period after index hospitalization

Time frame: 3 months

1-month urgent HF visits

Urgent or unscheduled visit with new or worsening symptoms of acute heart failure requiring initiation of intravenous diuretic or vasoactive agent or mechanical or surgical intervention, with no hospital admission, during a 1-month follow-up period after index hospitalization

Time frame: 1 month

1-year worsening in NYHA class

Worsening of New York Heart Association (NYHA) Functional Classification (Class I to IV) at 12 months from the index hospitalization.

Time frame: 12 months

Longitudinal Multimarker Risk Models for Very Elderly Patients With Heart Failure and Preserved Ejection Fraction

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes