MedamacsSeattle Heart Failure Risk Score Evaluation in Advanced Heart Disease Patients
This observational study aims to evaluate the number of participants with advanced heart disease who pass away within 24 months, using the Seattle Heart Failure Risk Score as a predictive tool.
Data Collection
Collected from today forward - ProspectiveCardiovascular Diseases+1
+ Heart Diseases
+ Heart Failure
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.This study focuses on individuals between 18 and 80 years old who have a history of low ejection fraction and hospitalization for heart failure within the past year. The goal is to screen and recruit these individuals, either during their stay at the hospital or during their first outpatient follow-up appointment. The study aims to evaluate the condition of patients with advanced heart disease, using clinically available information at the time of screening. This includes a routine evaluation and triage, which consists of echocardiography and functional assessment with peak oxygen consumption and frequently a 6 minute walk distance. The Seattle Heart Failure Risk score will be calculated using laboratory data or imputed as described in the Seattle score literature. The study is important as it helps to understand the condition better and potentially improve care for patients with advanced heart disease. Participants will be followed every 6 months for 24 months after two baseline visits. The follow-ups at 6 months and 18 months will be conducted through telephone interviews, while the follow-ups at 12 months and 24 months will be routine clinical visits. The primary outcome of the study is to determine the number of heart failure participants who are deceased at 24 months. Approximately 350 patients from 12 centers in the United States will be enrolled over a 12 month period.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.171 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION CRITERIA: Patients with Advanced Heart Failure 1. Age 18-80 years 2. New York Heart Association class III-IV heart failure for 45 of the last 60 days 3. Left ventricular ejection fraction ≤ 35% 4. Heart failure diagnosis or typical symptoms for 12 months 5. Use of evidence based oral medications (beta-blockers, ACE-inhibitors/ARBs, aldosterone antagonist) for at least 3 months prior to enrollment or documented medication contraindication or intolerance. 6. Hospitalization for heart failure within the previous 12 months (other than for elective procedure) 7. Informed consent given In Addition, they must have at least one of the following: An additional unplanned hospitalization during the previous 12 months for a total of at least 2 inpatient hospitalizations lasting \>24 hours with heart failure as the primary or secondary diagnosis within the previous 12 months OR 1. Peak oxygen uptake (VO2) \<55% of age- and sex-predicted (using Wasserman equation) OR a peak VO2 ≤16 ml/kg/min for men and ≤14 ml/kg/min for women in a test with an RER \>1.08 on cardiopulmonary exercise testing. 2. 6-minute walk distance \<300 meters without non-cardiac limitation. 3. Serum BNP \> 1000 (NT-proBNP \> 4000 pg/ml) as outpatient or at hospital discharge. OR Seattle Heart Failure Model Score \> 1.5. EXCLUSION CRITERIA: 1. Age \>80 years or \<18 years 2. Non-cardiac diagnosis anticipated to limit 2-year survival (≥30-50% mortality within 2 years from non-cardiac diagnosis) 3. Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival 4. QRS \> 120msec and planned biventricular pacemaker implant or biventricular pacemaker implantation within past 90 days 5. Current home intravenous inotrope therapy 6. Chronic hemodialysis or peritoneal dialysis 7. Scheduled for non-ventricular assist device cardiac surgery on current hospital admission 8. Obvious anatomical or other major contra-indication to any cardiac surgery in the future (e.g. previous pneumonectomy, advanced connective tissue disease) 9. Actively listed for heart transplant as UNOS Status 1 or 2 10. History of cardiac amyloidosis 11. Dominant lesion of at least moderate aortic or mitral stenosis or congenital structural heart defect.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 11 locations
University of Alabama at Birmingham
Birmingham, United StatesOpen University of Alabama at Birmingham in Google MapsCedars Sinai Medical Center
Beverly Hills, United StatesUniversity of Colorado
Aurora, United StatesUniversity of Iowa Hospitals and Clinics
Iowa City, United States