Feasibility of Implementation of Recommended Standards in Patients With Heart Failure

NCT04806048 | Completed

• 1 other identifier: HF-Outcomes-Spain
• Study Type: observational
• Target: 581
• Locations: 1 country
• Sites: 6

Brief Summary

Longitudinal pilot study among heart failure patients from six Spanish hospitals to evaluate the feasibility of establishing and maintaining for one year the set of standards for measuring results in patients with heart failure proposed by ICHOM (International Consortium for Health Outcomes Measurement), as well as identifying factors that hinder the use and applicability of this group of standards in real life, where appropriate, defined as the variables not filled in and the reason for the absence of such information.

Conditions

Heart Failure

Keywords

Outcome; Heart-Failure; Standard of care

Outcome Measures

Primary Outcomes (1)

• Patients in follow-up

  Proportion of patients who receive their recommended follow-up plan

  Up to 1 year

Study Arms (1)

Hospitalized patients and outpatients

There may be different types of patients with differing follow-up plan but all will bie considered one group regarding on whether they receive their recommended follow-up plan

Eligibility Criteria

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

Study Population

Based on the situation at the time of inclusion,5 types of patients are defined that reflect different clinical situations and influence the necessary follow-up plan. A.Hospitalized patients: 1. A recent diagnosis (at that admission), that is, they did not previously have the diagnosis of HF 2. Patients with a previous diagnosis of HF and who are admitted for an episode of decompensation of HF. B.Outpatients: 1. A recent diagnosis that is in the process of titling and/or compensation 2. A previous diagnosis, that they have suffered a decompensation, well defined because they have had to go to the emergency room (and the diuretic treatment has been increased) or have been seen in the outpatient clinic for that reason 3. "Stable" patients attending a follow-up visit.A simple follow-up

You may qualify if:

• Patients aged 18 years or older.
• Diagnosed with heart failure: Clinical identification of signs and symptoms of heart failure and objective evidence of heart dysfunction.
• Acute presentation (first presentation or decompensation of already known HF, whether or not it causes hospital admission) or chronic (stable outpatients) of any etiology
• Any value of the ejection fraction.
• Give writed informed consent to participate in the study.

You may not qualify if:

• Patients whose first manifestation of heart failure is cardiogenic shock, in that first episode. Those patients who survived an initial episode of shock and remain in heart failure can be included once stabilized.
• Heart transplant patients
• Patients with long-lasting ventricular assist devices
• Patients with isolated right heart failure.
• Patients with onset of heart failure and whose cause can be corrected immediately (eg, acute ischemia).

Sponsors & Collaborators

• Fundacion Profesor Novoa Santos: lead
• ODDS , S.L.: collaborator
• Vifor Pharma España, S.L.: collaborator

Study Sites (6)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Universitario Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Hospital Universitario de A Coruña

A Coruña, 15006, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (8)

• Groenewegen A, Rutten FH, Mosterd A, Hoes AW. Epidemiology of heart failure. Eur J Heart Fail. 2020 Aug;22(8):1342-1356. doi: 10.1002/ejhf.1858. Epub 2020 Jun 1.

  PMID: 32483830 BACKGROUND

• Anguita Sanchez M, Crespo Leiro MG, de Teresa Galvan E, Jimenez Navarro M, Alonso-Pulpon L, Muniz Garcia J; PRICE Study Investigators. Prevalence of heart failure in the Spanish general population aged over 45 years. The PRICE Study. Rev Esp Cardiol. 2008 Oct;61(10):1041-9. doi: 10.1016/s1885-5857(09)60007-4.

  PMID: 18817680 BACKGROUND

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

  PMID: 27207191 BACKGROUND

• Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.

  PMID: 24491689 BACKGROUND

• Anguita Sanchez M, Lambert Rodriguez JL, Bover Freire R, Comin Colet J, Crespo Leiro MG, Gonzalez Vilchez F, Manito Lorite N, Segovia Cubero J, Ruiz Mateas F, Elola Somoza FJ, Iniguez Romo A. Classification and Quality Standards of Heart Failure Units: Scientific Consensus of the Spanish Society of Cardiology. Rev Esp Cardiol (Engl Ed). 2016 Oct;69(10):940-950. doi: 10.1016/j.rec.2016.06.006. Epub 2016 Aug 27. English, Spanish.

  PMID: 27576081 BACKGROUND

• McDonagh TA, Blue L, Clark AL, Dahlstrom U, Ekman I, Lainscak M, McDonald K, Ryder M, Stromberg A, Jaarsma T; European Society of Cardiology Heart Failure Association Committee on Patient Care. European Society of Cardiology Heart Failure Association Standards for delivering heart failure care. Eur J Heart Fail. 2011 Mar;13(3):235-41. doi: 10.1093/eurjhf/hfq221. Epub 2010 Dec 15.

  PMID: 21159794 BACKGROUND

• Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, Filippatos GS, Hardman S, Hoes AW, Hutchison S, Jessup M, Kinsella T, Knapton M, Lam CSP, Masoudi FA, McIntyre H, Mindham R, Morgan L, Otterspoor L, Parker V, Persson HE, Pinnock C, Reid CM, Riley J, Stevenson LW, McDonagh TA. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC Heart Fail. 2020 Mar;8(3):212-222. doi: 10.1016/j.jchf.2019.09.007. Epub 2019 Dec 11.

  PMID: 31838032 BACKGROUND

• McNamara RL, Spatz ES, Kelley TA, Stowell CJ, Beltrame J, Heidenreich P, Tresserras R, Jernberg T, Chua T, Morgan L, Panigrahi B, Rosas Ruiz A, Rumsfeld JS, Sadwin L, Schoeberl M, Shahian D, Weston C, Yeh R, Lewin J. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015 May 19;4(5):e001767. doi: 10.1161/JAHA.115.001767.

  PMID: 25991011 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• María G Crespo Leiro, MD

  Complejo Hospitalario Universitario de A Coruña (CHUAC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Heart Failure Unit

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: March 19, 2021
• Study Start: June 1, 2021
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: April 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)