Most hospitalized older persons do not meet the enrollment criteria for clinical trials in heart failure

Masoudi, Frederick A.; Havranek, Edward P.; Wolfe, Pam; Gross, Cary P.; Rathore, Saif S.; Steiner, John F.; Ordin, Diana L.; Krumholz, Harlan M.

doi:10.1016/s0002-8703(03)00189-3

Cited by 291 publications

(198 citation statements)

References 20 publications

Supporting

Mentioning

182

Contrasting

Unclassified

Order By: Relevance

“…This approach was also used in PARADIGM‐HF with 20 key exclusion criteria, in addition to the already strict entry criteria 19. Real‐world patients rarely fit into those tight frames,1, 14, 15, 16, 17, 18 and we have 75% of our HFrEF population who does not meet the entry criteria, but we still have to give them the best treatment possible. Previous studies have shown that between 10% and 66% of real‐world patients managed to fulfil all enrolment criteria from heart failure RCTs 15, 17.…”

Section: Discussionmentioning

confidence: 99%

“…Real‐world patients rarely fit into those tight frames,1, 14, 15, 16, 17, 18 and we have 75% of our HFrEF population who does not meet the entry criteria, but we still have to give them the best treatment possible. Previous studies have shown that between 10% and 66% of real‐world patients managed to fulfil all enrolment criteria from heart failure RCTs 15, 17. A recent study applying the strict PARADIGM‐HF main criteria on a heart failure clinic showed that 21% of a HFrEF population was eligible for sacubitril–valsartan 20.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Eligibility of sacubitril–valsartan in a real‐world heart failure population: a community‐based single‐centre study

2018

View full text Add to dashboard Cite

AimsThis 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 resultsMedical 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.ConclusionsOnly 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.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Eligibility of sacubitril–valsartan in a real‐world heart failure population: a community‐based single‐centre study

2018

View full text Add to dashboard Cite

show abstract

“…33 The overall usage rates of RAS inhibitors or β-blockers in the CHART-2 patients were 64.6% and 40.4%, respectively ( Figure 5). Although the penetration rate of such treatment was increased in overt HF patients in the CHART-2 Study compared with the CHART-1 Study ( Table 2), it was still too low, especially in stage B patients ( Figure 5).…”

Section: Use Of Standard Medication For Cvd In the Chart-2 Patientsmentioning

confidence: 99%

Trend of Westernization of Etiology and Clinical Characteristics of Heart Failure Patients in Japan

Shiba

Nochioka

Miura

et al. 2011

Circ J

224

205

View full text Add to dashboard Cite

on behalf of the CHART-2 Investigators Background: Hospitalization due to acute heart failure syndrome (AHFS) is an indicator of worsened prognosis for patients with cardiovascular disease (CVD). The Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2) Study was designed to elucidate characteristics and prognosis of patients at high risk for CVD progression due to AHFS. Methods and Results:The CHART-2 Study is a prospective observational multicenter cohort study. Patients with overt HF, structural cardiac disorder but without HF, or with coronary artery disease (CAD) have been consecutively enrolled from October 2006. As of March 2010, a total of 10,219 patients have been recruited, making the Study the largest multicenter prospective cohort of HF patients in Japan. The mean patient age was 68.2± 12.3 years and male patients accounted for 69.8%. Overt HF was observed in 46.3% of patients; and 53.7% did not have HF but were at high risk for AHFS. As HF stage progressed, the prognostic risks (eg, chronic kidney disease, reduced ejection fraction, and increased B-type natriuretic peptide level) became more prominent. Compared with the previous CHART-1 study, the prevalence of ischemic etiology and risk factors (hypertension, diabetes) have increased, as in Western studies. Conclusions:This first report demonstrates the trend of westernization of ischemic etiology and clinical characteristics of HF patients in Japan, indicating the importance of appropriate management and prevention of CAD to prevent AHFS. (Circ J 2011; 75: 823 - 833)

show abstract

“…The restrictions resulting from stringent inclusion and exclusion criteria for randomised controlled trails particularly limit recruitment in studies of older people. Masoudi et al [22], have reported similarly low recruitment rates for clinical trials of heart failure in older people. The oldest patients and women are particularly unlikely to meet trial criteria.…”

Section: Discussionmentioning

confidence: 99%

Recruiting Older People at Nutritional Risk for Clinical Trials: What Have We Learned?

Naganathan

Piantadosi

Chapman

et al. 2017

Innovation in Aging

View full text Add to dashboard Cite

Background: The difficulty of recruiting older people to clinical trials is well described, but there is limited information about effective ways to screen and recruit older people into trials, and the reasons for their reluctance to enrol. This paper examines recruitment efforts for a community-based health intervention study that targeted older adults. Methods: One year randomized control trial. Undernourished men and women, aged ≥ 65 years and living independently in the community were recruited in three Australian states. Participants were allocated to either oral testosterone undecanoate and high calorie oral nutritional supplement or placebo medication and low calorie oral nutritional supplementation. Hospital admissions, functional status, nutritional health, muscle strength, and other variables were assessed. Results: 4023 potential participants were identified and 767 were screened by a variety of methods: hospital note screening, referrals from geriatric health services, advertising and media segments/appearances. 53 participants (7% of total screened) were recruited. The majority of potentially eligible participants declined participation in the trial after reading the information sheet. Media was the more successful method of recruiting, whereas contacting people identified by screening a large number of hospital records was not successful in recruiting any participants.

show abstract

Most hospitalized older persons do not meet the enrollment criteria for clinical trials in heart failure

Cited by 291 publications

References 20 publications

Eligibility of sacubitril–valsartan in a real‐world heart failure population: a community‐based single‐centre study

Eligibility of sacubitril–valsartan in a real‐world heart failure population: a community‐based single‐centre study

Trend of Westernization of Etiology and Clinical Characteristics of Heart Failure Patients in Japan

Recruiting Older People at Nutritional Risk for Clinical Trials: What Have We Learned?

Contact Info

Product

Resources

About