Lessons Learned from Clinical Trials in Acute Heart Failure: Phase 3 Drug Trials

2011 ◽  
Vol 7 (4) ◽  
pp. 451-456 ◽  
Author(s):  
Christopher M. O’Connor ◽  
Mona Fiuzat
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Acute Heart Failure ◽  
Lessons Learned ◽  
Drug Trials ◽  
Phase 3

scholarly journals Clinical Trials of Pharmacological Therapies in Acute Heart Failure Syndromes

2010 ◽  
Vol 3 (2) ◽  
pp. 314-325 ◽  
Author(s):  
G. Michael Felker ◽  
Peter S. Pang ◽  
Kirkwood F. Adams ◽  
John G.F. Cleland ◽  
Gad Cotter ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Acute Heart Failure ◽  
Acute Heart Failure Syndromes

scholarly journals 32 Quantifying the Prevalence of Frailty in Drug Trials and the Relationship with Serious Adverse Events

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i7-i11
Author(s):  
P Hanlon ◽  
E Butterly ◽  
J Lewsey ◽  
S Siebert ◽  
F S Mair ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Disease Severity ◽  
Negative Binomial ◽  
Frailty Index ◽  
Chronic Obstructive ◽  
Drug Trials ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Increased Risk

Abstract Introduction Frailty is common in clinical practice, but trials rarely report on participant frailty. Consequently, clinicians and guideline-developers assume frailty is largely absent from trials and have questioned the relevance of trial findings to frail people. Therefore, we examined frailty in phase 3/4 industry-sponsored clinical trials of pharmacological interventions for three exemplar conditions: type 2 diabetes mellitus (T2DM), rheumatoid arthritis (RA), and chronic obstructive pulmonary disease (COPD). Methods We constructed a 40-item frailty index (FI) in 19 clinical trials (7 T2DM, 8 RA, 4 COPD, mean age 42–65 years) using individual-level participant data. Participants with a FI >0.24 were considered “frail”. Baseline disease severity was assessed using HbA1c for T2DM, Disease Activity Score-28 (DAS28) for RA, and % predicted FEV1 for COPD. Using generalised gamma regression, we modelled FI on age, sex and disease severity. In negative binomial regression we modelled serious adverse event rates on FI, and combined results for each index condition in a random-effects meta-analysis. Results All trials included frail participants: prevalence 7–21% in T2DM trials, 33–73% in RA trials, and 15–22% in COPD trials. Increased disease severity and female sex were associated with higher FI in all trials. Frailty was associated with age in T2DM and RA trials, but not in COPD. Across all trials, and after adjusting for age, sex, and disease severity, higher FI predicted increased risk of serious adverse events; the pooled incidence rate ratios (per 0.1-point increase in FI scale) were 1.46 (95% CI 1.21–1.75), 1.45 (1.13–1.87) and 1.99 (1.43–2.76) for T2DM, RA and COPD, respectively. Conclusion Frailty is identifiable and prevalent among middle aged and older participants in phase 3/4 drug trials and has clinically important safety implications. Trial data may be harnessed to better understand chronic disease management in people living with frailty.

scholarly journals End Points for Clinical Trials in Acute Heart Failure Syndromes

2009 ◽  
Vol 53 (24) ◽  
pp. 2248-2258 ◽  
Author(s):  
Larry A. Allen ◽  
Adrian F. Hernandez ◽  
Christopher M. O'Connor ◽  
G. Michael Felker
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Acute Heart Failure ◽  
End Points ◽  
Acute Heart Failure Syndromes

scholarly journals A proposal to standardize dyspnoea measurement in clinical trials of acute heart failure syndromes: the need for a uniform approach

2008 ◽  
Vol 29 (6) ◽  
pp. 816-824 ◽  
Author(s):  
P. S. Pang ◽  
J. G.F. Cleland ◽  
J. R. Teerlink ◽  
S. P. Collins ◽  
C. J. Lindsell ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Acute Heart Failure ◽  
Uniform Approach ◽  
Acute Heart Failure Syndromes

scholarly journals An analysis of certain fields of interventional drug trials registered with Clinical Trials Registry – India

2019 ◽  
Author(s):  
Mounika Pillamarapu ◽  
Abhilash Mohan ◽  
Gayatri Saberwal
Keyword(s):  
Clinical Trials ◽  
Large Fraction ◽  
Ethics Committees ◽  
Drug Trials ◽  
Recent Past ◽  
Phase 3 ◽  
New Policies ◽  
Clinical Trials Registry ◽  
Sqlite Database ◽  
Phase Phase

Abstract Background There has been a significant increase in the number of trials registered with Clinical Trials Registry – India (CTRI) recently. We therefore wished to understand the current landscape of interventional, drug trials that have run in India. Methods We downloaded all trial records on 4 April 2018, and queried the data after it was formatted into an SQLite database. We distinguished trials hosted by India (India-only trials) and those co-hosted by India and other countries (India-etc trials). Results We analyzed eight fields of data, with the following key results: (a) Year of registration: The India-etc set suffered a serious dip in 2013. Both sets increased sharply in 2017. (b) Phase: Phase 3 trials were the most common in both sets of data, but were manifold more common in the India-etc set. 30% of the India-only trials had no phase information. (c) Trial sites: Four states each account for 50% or more of the sites in both sets of data. Also, 7–8 cities accounted for 50% or more sites in both sets. (d) Ethics committees: Over 70% of India-only trials had a single ethics committee, but the India-etc trials had a much greater spread. For each set, the maximum exceeded 60 committees per trial. (e) Principal Investigator (PI): 84% and 73% of PIs in the India-only and India-etc sets, respectively, had run a single trial each. One PI had run as many as 44 trials. (f) Primary sponsors: global pharma companies sponsored less than 5% of the India-only set but 92% of the India-etc set. (g) Fraction of subjects from India in India-etc trials: An abnormally large fraction of participants are not recruited from India. (h) Countries co-hosting the India-etc trials: The pattern was similar to that found for international trials co-hosted by Australia. Conclusions It is important to understand the landscape of trials being run in any country, to understand the recent past, in case of any red flags, and to serve as inputs to changes in policy. The data also serves as a baseline for the future, to ascertain the impacts of new policies, locally or globally.

How to measure dyspnea in acute heart failure?

2009 ◽  
Vol 66 (9) ◽  
pp. 639-642 ◽  
Author(s):  
Thenral Socrates ◽  
Alexandre Mebazaa
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Acute Heart Failure ◽  
Analogue Scale ◽  
Time Course ◽  
Sitting Position ◽  
Point Scale ◽  
Course Of Disease ◽  
Important Target

Dyspnea is the most common presenting symptom of patients with acute heart failure (AHF). Although dyspnea is an important target for treatment in clinical practice and clinical trials, there remains a lack of consensus on how to assess it. We describe and recommend to use absolute scales such the Likert 5-point or the Visual Analogue Scale rather than any comparator scale such as the Likert 7-point scale. We further recommend starting dyspnea measurements in sitting position and perform, if possible, similar measurements in lying position. The same set of measurements may be repeated as needed during the time course of disease and the treatment.

scholarly journals Improvement of Cardiac Vegetations in Antiphospholipid Syndrome with Enoxaparin and Corticosteroids after Rivaroxaban Failure

2018 ◽  
Vol 2018 ◽  
pp. 1-4
Author(s):  
Eric Granowicz ◽  
Kiyon Chung
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Autoimmune Disease ◽  
Acute Heart Failure ◽  
Antiphospholipid Syndrome ◽  
Steroid Therapy ◽  
Cardiac Disease ◽  
Marked Improvement ◽  
Cardiac Involvement

Cardiac disease is a well-known complication of antiphospholipid syndrome (APS), with many patients presenting with valvular thickening or vegetations, referred to as Libman–Sacks endocarditis (LSE). Because cases of APS with cardiac involvement are relatively rare, paucity of large clinical trials studying this complication has made management challenging. In the absence of acute heart failure and embolic events, a medical approach is usually selected, consisting of anticoagulation and possibly corticosteroids when another underlying autoimmune disease is present. However, the role of various anticoagulant classes and the duration of steroid therapy continue to be debated. Here, we present a 45-year-old woman who developed two vegetations in the setting of secondary APS while taking rivaroxaban before experiencing marked improvement with the use of enoxaparin and steroids.

Sign in / Sign up

Export Citation Format

Share Document