Heart Failure STratification and OutcomeS

NCT02444676 | Completed DMC

• 1 other identifier: PI 00269
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Heart failure (HF) is in many cases the final way for coronary heart diseases. In older than 65 years is the most important cause of hospitalization. Many studies have analyzed the causes of decompensation and the possible causes of hospital re-admission but most evidences come from the hospital setting. Nevertheless, It is known that many of these patients are usually attended in primary care setting, being treated by their General Practitioner and are not referred to the hospital. The determinants which condition whether stable HF patients will be hospitalized as a consequence of a decompensation remain still unclear. Objective: To develop and validate a predictive model based on clinical variables easy to measure at primary care to predict short-term hospitalization or mortality in a cohort of patients attended in primary care setting as a consequence of a HF decompensation. Methods: A cohort of patients with established HF attended in primary care setting (regular care or out of hours) as a consequence of an episode of HF decompensation will be follow up. To develop the predictive model we will select variables which previously have been found involved in the risk of hospitalization or mortality as a consequence of HF as well as other ones which could be relevant and have not been studied yet. Variables selected should be easily determined in primary care setting.. The predictive model obtained in the derivation cohort from Spain will be validated in an external (several European countries) validation cohort. Relevance: Our study will help GP to identify HF patients at higher risk of hospitalization or death and manage them according to an accurate prognostic rule (escala pronostica) made in primary care setting.\[DISCUTIR\]

Conditions

HEART FAILURE

Outcome Measures

Primary Outcomes (2)

• Hospital admission

  Hospital admission during the following 30 days as a consequence of the episode of decompensation. (We will consider hospital admission a stay at hospital \> 24 hours.)

  30 days

• Mortality

  Mortality during the first 30 days after the episode of decompensation (at home or at the hospital).

  30 days

Interventions

Stratification and outcomes OTHER

No necessary

Also known as: observational study

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart Failure patients included in the study will come from primary care setting. We consider primary care, the health assistance provided in outpatients by a General practitioner, or out of hours care in primary care setting.

You may qualify if:

• Decompensation is defined as the presence of at least one of the following clinical conditions (12):
• The worsening functional class according to the criteria of the New York Heart Association (NYHA).
• A weight gain of more than one kilogram in a period of 24 hours or greater than two kilograms in a maximum of 72 hours.
• Increased ankle edema (self-reported by the patient, caregiver or physician)

You may not qualify if:

• Patients with severe psychiatric illness or severe cognitive impairment, not able to complete the study protocol.
• Refusal to participate in the study.
• Patients directly attended in the hospital in the previous 30 days.
• Every patient will be followed up to 30 days after the decompensation episode. We are intended to consecutively including patients in the study during a period of two years, from December 2014 to December 2016.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

Institut Català de la Salut

Barcelona, Spain

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Treatment Outcome; Observation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prognosis; Diagnosis; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation; Methods; Investigative Techniques

Study Officials

• Jose M Verdú, PhD, MD

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 5, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)