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Assessing the Eligibility Criteria in Phase III Randomized Controlled Trials of Drug Therapy in Heart Failure With Preserved Ejection Fraction: The Critical Play-Off Between a 'Pure' Patient Phenotype and the Generalizability of Trial Findings
- Source :
- Journal of cardiac failure. 23(7)
- Publication Year :
- 2016
-
Abstract
- Aims To investigate the effect of the different eligibility criteria used by phase III clinical studies in heart failure with preserved ejection fraction (HFpEF) on patient selection, phenotype, and survival. Methods and Results We applied the key eligibility criteria of 7 phase III HFpEF studies (Digitalis Investigation Group Ancillary, Candesartan in Patients With Chronic Heart Failure and Preserved Left-Ventricular Ejection Fraction, Perindopril in Elderly People With Chronic Heart Failure, Irbesartan in Heart Failure With Preserved Systolic Function, Japanese Diastolic Heart Failure, Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist, and Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF; ongoing]) to a typical and well-characterized HFpEF population (n = 557) seen in modern European cardiological practice. Follow-up was available for a minimum of 24 months in each patient. Increasing the number of study eligibility criteria identifies a progressively smaller group of patients from real-life practice suitable for recruitment into clinical trials; using the J-DHF criteria, 81% of our clinic patients would have been eligible, whereas the PARAGON-HF criteria significantly reduced this proportion to 32%. The patients identified from our clinical population had similar mortality rates using the different criteria, which were consistently higher than those reported in the actual clinic trials. Conclusions Trial eligibility criteria have become stricter with time, which reduces the number of eligible patients, affecting both generalizability of any findings and feasibility of completing an adequately powered trial. We could not find evidence that the additional criteria used in more recent randomized trials in HFpEF have identified patients at higher risk of all-cause mortality.
- Subjects :
- Male
Cardiac & Cardiovascular Systems
diagnosis
Angiotensin-Converting Enzyme Inhibitors
030204 cardiovascular system & hematology
GUIDELINES
COLLABORATION
law.invention
0302 clinical medicine
Randomized controlled trial
law
030212 general & internal medicine
Randomized Controlled Trials as Topic
Aged, 80 and over
education.field_of_study
Ejection fraction
phase III clinical trials
Diastolic heart failure
PRIMARY-CARE
ASSOCIATION
Middle Aged
SPIRONOLACTONE
EUROPEAN-SOCIETY
Heart failure with preserved ejection fraction
Phenotype
Valsartan
Female
Cardiology and Cardiovascular Medicine
ECHOCARDIOGRAPHY
Life Sciences & Biomedicine
trial selection criteria
CLINICAL-TRIALS
medicine.drug
medicine.medical_specialty
Population
1102 Cardiovascular Medicine And Haematology
03 medical and health sciences
Internal medicine
medicine
Humans
Mortality
Intensive care medicine
education
Aged
Retrospective Studies
Heart Failure
Science & Technology
business.industry
Patient Selection
1103 Clinical Sciences
Stroke Volume
medicine.disease
Clinical trial
Cardiovascular System & Hematology
Clinical Trials, Phase III as Topic
Heart failure
Cardiovascular System & Cardiology
business
Angiotensin II Type 1 Receptor Blockers
TASK-FORCE
Follow-Up Studies
Subjects
Details
- ISSN :
- 15328414
- Volume :
- 23
- Issue :
- 7
- Database :
- OpenAIRE
- Journal :
- Journal of cardiac failure
- Accession number :
- edsair.doi.dedup.....11a2ad71828bd26f4ac57618461b2098