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

NCT05992558 | Active Not Recruiting

• 1 other identifier: PI21/00541
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Heart Failure; Preserved Ejection Fraction; Elderly; Prognostic model; Risk; Hospitalization

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (12)

• 1-year HF-hospitalization

  12 months

• 3-month HF-hospitalization

  3 months

• 1-month HF-hospitalization

  1 month

• 1-year all-cause hospitalization

  12 months

• 3-month all-cause hospitalization

  3 months

Study Arms (1)

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

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• Instituto de Salud Carlos III: collaborator
• European Union: collaborator

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Related Publications (8)

• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

  PMID: 34447992 BACKGROUND

• Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):1757-1780. doi: 10.1016/j.jacc.2021.12.011. Epub 2022 Apr 1.

  PMID: 35379504 BACKGROUND

• Taylor CJ, Moore J, O'Flynn N. Diagnosis and management of chronic heart failure: NICE guideline update 2018. Br J Gen Pract. 2019 May;69(682):265-266. doi: 10.3399/bjgp19X702665. No abstract available.

  PMID: 31023695 BACKGROUND

• Sicras-Mainar A, Sicras-Navarro A, Palacios B, Varela L, Delgado JF. Epidemiology and treatment of heart failure in Spain: the HF-PATHWAYS study. Rev Esp Cardiol (Engl Ed). 2022 Jan;75(1):31-38. doi: 10.1016/j.rec.2020.09.033. Epub 2020 Dec 27. English, Spanish.

  PMID: 33380382 BACKGROUND

• Kuster N, Huet F, Dupuy AM, Akodad M, Battistella P, Agullo A, Leclercq F, Kalmanovich E, Meilhac A, Aguilhon S, Cristol JP, Roubille F. Multimarker approach including CRP, sST2 and GDF-15 for prognostic stratification in stable heart failure. ESC Heart Fail. 2020 Oct;7(5):2230-2239. doi: 10.1002/ehf2.12680. Epub 2020 Jul 10.

  PMID: 32649062 BACKGROUND

• Nunez J, Bayes-Genis A, Revuelta-Lopez E, Ter Maaten JM, Minana G, Barallat J, Cserkoova A, Bodi V, Fernandez-Cisnal A, Nunez E, Sanchis J, Lang C, Ng LL, Metra M, Voors AA. Clinical Role of CA125 in Worsening Heart Failure: A BIOSTAT-CHF Study Subanalysis. JACC Heart Fail. 2020 May;8(5):386-397. doi: 10.1016/j.jchf.2019.12.005. Epub 2020 Mar 11.

  PMID: 32171764 BACKGROUND

• Pacho C, Domingo M, Nunez R, Lupon J, Nunez J, Barallat J, Moliner P, de Antonio M, Santesmases J, Cediel G, Roura S, Pastor MC, Tor J, Bayes-Genis A. Predictive biomarkers for death and rehospitalization in comorbid frail elderly heart failure patients. BMC Geriatr. 2018 May 9;18(1):109. doi: 10.1186/s12877-018-0807-2.

  PMID: 29743019 BACKGROUND

• Levy WC, Mozaffarian D, Linker DT, Sutradhar SC, Anker SD, Cropp AB, Anand I, Maggioni A, Burton P, Sullivan MD, Pitt B, Poole-Wilson PA, Mann DL, Packer M. The Seattle Heart Failure Model: prediction of survival in heart failure. Circulation. 2006 Mar 21;113(11):1424-33. doi: 10.1161/CIRCULATIONAHA.105.584102. Epub 2006 Mar 13.

  PMID: 16534009 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, EDTA plasma, lithium heparin plasma, and buffy coat.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Luis Manzano Espinosa, MD PhD

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 15, 2023
• Study Start: March 21, 2023
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From 1 year after the end of the project and for at least 5 years.
• 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.

Locations

ES (1)