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

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (Other)

Overall Status

Recruiting

CT.gov ID

NCT05992558

Collaborator

Instituto de Salud Carlos III (Other), European Union (Other)

184

Enrollment

Location

21.4

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Preserved Ejection Fraction

Detailed Description

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

184 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Development of Longitudinal Multimarker Risk Models for Decision Support Across the Clinical Follow-up of Very Elderly Patients With Heart Failure and Preserved Ejection Fraction

Actual Study Start Date :

Mar 21, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Very elderly HFpEF Prospective cohort of very elderly patients (≥80 years old) with heart failure with preserved ejection fraction (HFpEF) consecutively admitted for acute HF

Outcome Measures

Primary Outcome Measures

Composite of 1-year all-cause mortality and/or HF-hospitalization [12 months]
Combined outcome of all-cause mortality and/or readmission for acute heart failure during a 12-month follow-up period after index hospitalization

Secondary Outcome Measures

1-year HF-hospitalization [12 months]
Readmission for acute heart failure during a 12-month follow-up period after index hospitalization
3-month HF-hospitalization [3 months]
Readmission for acute heart failure during a 3-month follow-up period after index hospitalization
1-month HF-hospitalization [1 month]
Readmission for acute heart failure during a 1-month follow-up period after index hospitalization
1-year all-cause hospitalization [12 months]
All-cause readmission during a 12-month follow-up period after index hospitalization
3-month all-cause hospitalization [3 months]
All-cause readmission during a 3-month follow-up period after index hospitalization
1-month all-cause hospitalization [1 month]
All-cause readmission during a 1-month follow-up period after index hospitalization
1-year all-cause mortality [12 months]
All-cause mortality during a 12-month follow-up period after index hospitalization
1-year cardiovascular mortality [12 months]
Cardiovascular mortality during a 12-month follow-up period after index hospitalization
1-year urgent HF visits [12 months]
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
3-month urgent HF visits [3 months]
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
1-month urgent HF visits [1 month]
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
1-year worsening in NYHA class [12 months]
Worsening of New York Heart Association (NYHA) Functional Classification (Class I to IV) at 12 months from the index hospitalization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

80 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age ≥80 years;
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;
hospitalization with a primary diagnosis of acute HF; and
giving informed consent.

Exclusion Criteria:

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;
any clinical or social condition that prevents clinical follow-up.