Related Experiment Video
Updated: Feb 15, 2026
Author Spotlight: Investigating HR-Dependent Cardiac Function in Mouse Models Through a Novel Atrial-Pacing Approach
Published on: July 21, 2023
Eligibility of sacubitril-valsartan in a real-world heart failure population: a community-based single-centre study
Helena Norberg1,2, Ellinor Bergdahl2, Krister Lindmark2
1Department of Pharmacology and Clinical Neuroscience, Umeå University, S-901 87, Umeå, Sweden.
Insights
Only 24% of real-world heart failure patients met eligibility for sacubitril-valsartan, highlighting a gap between clinical trials and practice. This study found eligible patients were older and had more comorbidities than those in the PARADIGM-HF trial.
Area of Science:
- Cardiology
- Clinical Trials
- Real-World Evidence
Background:
- The PARADIGM-HF trial established the efficacy of sacubitril-valsartan for heart failure with reduced ejection fraction (HFrEF).
- Understanding the generalizability of PARADIGM-HF criteria to real-world HFrEF populations is crucial for treatment application.
Purpose of the Study:
- To assess the eligibility of a real-world heart failure population for the PARADIGM-HF study criteria.
- To compare the characteristics of eligible versus ineligible real-world patients with those in the PARADIGM-HF trial.
Main Methods:
- Retrospective review of medical records for heart failure patients at Umeå University Hospital.
- Application of major PARADIGM-HF inclusion criteria to identify eligible patients.
- Comparison of demographic and clinical characteristics between eligible real-world patients and the PARADIGM-HF cohort.
Main Results:
- Out of 2029 heart failure patients, 401 had ejection fraction ≤35%.
- Only 95 patients (5% of all HF, 24% of HFrEF) met PARADIGM-HF eligibility criteria.
- Eligible real-world patients were older and had higher rates of atrial fibrillation compared to the PARADIGM-HF population.
Conclusions:
- A significant gap exists between PARADIGM-HF eligibility criteria and the characteristics of the broader real-world HFrEF population.
- The findings suggest limitations in extrapolating trial results directly to clinical practice.
- Registry-based randomized trials may offer a solution for evaluating treatments in diverse, real-world patient groups.
Aims:
This study aims to investigate the eligibility of the Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor (ARNI) with ACE inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) study to a real-world heart failure population.
Methods And Results:
Medical records of all heart failure patients living within the catchment area of Umeå University Hospital were reviewed. This district consists of around 150 000 people. Out of 2029 patients with a diagnosis of heart failure, 1924 (95%) had at least one echocardiography performed, and 401 patients had an ejection fraction of ≤35% at their latest examination. The major PARADIGM-HF criteria were applied, and 95 patients fulfilled all enrolment criteria and thus were eligible for sacubitril-valsartan. This corresponds to 5% of the overall heart failure population and 24% of the population with ejection fraction ≤ 35%. The eligible patients were significantly older (73.2 ± 10.3 vs. 63.8 ± 11.5 years), had higher blood pressure (128 ± 17 vs. 122 ± 15 mmHg), had higher heart rate (77 ± 17 vs. 72 ± 12 b.p.m.), and had more atrial fibrillation (51.6% vs. 36.2%) than did the PARADIGM-HF population.
Conclusions:
Only 24% of our real-world heart failure and reduced ejection fraction population was eligible for sacubitril-valsartan, and the real-world heart failure and reduced ejection fraction patients were significantly older than the PARADIGM-HF population. The lack of data on a majority of the patients that we see in clinical practice is a real problem, and we are limited to extrapolation of results on a slightly different population. This is difficult to address, but perhaps registry-based randomized clinical trials will help to solve this issue.
Related Concept Videos
00:30What are Populations and Communities?
01:29Heart Failure II: Pathophysiology
01:17Pathophysiology of Heart Failure
01:27Heart Failure I: Introduction
01:22Heart Failure VI: Adjunct Therapies
01:22Heart Failure Drugs: Diuretics