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

August 16, 2023 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jose María Fernández Rodríguez, MD
        • Sub-Investigator:
          • Pau Llácer Iborra, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Very elderly patients (≥80 years old) with HFpEF consecutively admitted for acute HF at Hospital Universitario Ramón y Cajal and followed up at Unit of Heart Failure (UICA) of the Internal Medicine Dept.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of 1-year all-cause mortality and/or HF-hospitalization
Time Frame: 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
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Collaborators

Instituto de Salud Carlos III
European Union

Investigators

  • Principal Investigator: Luis Manzano Espinosa, MD PhD, Hospital Universitario Ramon y Cajal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI21/00541

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the end of the project, the generated dataset and the metadata file will be deposited in an open data repository, complying with open science criteria - FAIR.

Moreover, study documentation, including study protocol, statistical analysis and informed consent form will be shared openly.

IPD Sharing Time Frame

From 1 year after the end of the project and for at least 5 years.

IPD Sharing Access Criteria

IPD will be available to stakeholders, authorities, ethics committees and other parties legitimately interested in verifying their proper treatment and management.

IPD may be used to ensure the scientific quality of the project results. That is to say, to carry out reproducibility of the results, if necessary at the request of scientific publication entities, among others, with prior authorization from the Research Ethics Committee, they may be reused for new research projects, provided that the consent collected allows it and/or in accordance with the applicable laws on data protection.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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