Identification of patients with heart failure and PREserved systolic Function : an Epidemiologic Regional study Dr. Antonio Magaña M.D. (on behalf I-PREFER investigators group) Stockholm, Sweden, August 2010
Prevalence (%) 10 9 8 7 6 5 4 EEUU (CHS) 55 Finland (Helsinki) 51 England 68 Sweden 46 Denmark (Copen.) 71 Spain 59 Portugal (EPICA) Holland (Rotter.) HF-Low EF HF-PSF 39 3 2 71 1 0 Age range Mean 66-103 75-86 70-84 75 50 >40 >25 55-95 78 76 75 60 68 65 Petrie M, McMurray J. Lancet. 2001;358:423-434 Hogg K et al. J Am Coll Card. 2004;43:317-327.
Drug LVEF Class Level of evidence EHFS-II ACE-I/ARB 40% >40% I I A C 76% 75% B-blockers 40% >40% I I A C 60% 57% Aldo blockers 40% >40% I - B - 52% 31% ESC HF Congress, Milan, Italy, june 2008
Protocol summary
Primary: To estimate in patients with heart failure the proportion of patients with heart failure and preserved systolic function (HF-PSF) (LVEF 45%) Secondary To estimate the proportion of patients with heart failure among patients attending cardiologists office To characterize the cardiovascular profile (mainly in relation to the presence of hypertension, diabetes and obesity) of patients with chronic heart failure attending cardiologists office To describe the diagnosis tools of heart failure To describe the management and treatment of patients with heart failure To compare the cardiovascular profile, therapeutic management of heart failure patients with and without preserved systolic function To describe the cardiovascular profile, therapeutic management of patients with heart failure in Africa, Middle East, Latin America
This study is divided into 2 parts: 1st part: Cardiology registry: Consists of the recording of ALL patients with or without HF visiting cardiologists consecutively over a 2-month period 1 st part Cardiology registry: All patients attending the consultation HF Study: Patients with HF (newly or already diagnosed) M0 M1 M2 M3
2 nd part: Heart failure study : 3-month non-interventional, cross-sectional, international, multi-center study in patients with heart failure. At least 5 patients up to 40 patients who satisfy the inclusion criteria will be included. Non-interventional: information collected on characteristics, management and treatments of patients with heart failure. The treatment is determined solely by the patient s investigator => data collected will mirror real life management of these patients. Cross-sectional : data will be collected only at baseline International: study will be conducted in Africa, Middle East and Latin America => enhance the significance of the results and allow analyses on a regional basis because management patterns can vary. Cardiology registry: All patients attending the consultation HF Study: Patients with HF (newly or already diagnosed) 2 nd part M0 M1 M2 M3
Inclusion criteria Exclusion criteria Male of female outpatients, over 21 years of age Patients newly or already diagnosed with chronic heart failure Signed informed consent obtained prior to study entry Patients with acute decompensation of heart failure Patients participating in a clinical trial
Cardiology Registry Investigator questionnaire( Site location, demographic data, specialty, number of years in practice, type of clinical practice) Investigator will record each day during 2 months : Total number of patients attending investigator s office Number of patients with HF Newly diagnosed Already known has having HF Number of patients included in the HF study.visit schedule
Heart failure study following data collected for each patient included Only one visit Cardiovascular profile Cardiovascular risk factors (Hypertension, Atrial fibrillation, Diabetes, Dyslipidemia, Smoking status, Alcohol consumption) Cardiovascular history Other co-morbidities (Renal failure, Chronic obstructive pulmonary disease, Cognitive decline, Sleep Apnea Syndrom) Heart failure etiology Diagnosis tools for HF (Chest X ray, ECG, Echocardiography, Cardiac catheterization, Laboratory exams) Current therapeutic management (Lifestyle measures and Pharmacological treatment)
Worldwide results
227 investigators from 10 countries Mean Age : 48.1 y ± 7.8 y 85% males 98% cardiologists Private hospital/clinic 41% University hospital 30% Office based 28% Non university public hospital 9%
Over a 2-month period, 2 ± 2.8 patients with HF per day representing 15 ± 15% of the total number of patients consulting 11% ± 11% with already known HF 4% ± 8% with newly diagnosed HF at the time of the consultation Ratio already known HF/newly diagnosed : 72/28%
Patients selected 2539 Patients analyzed 2536 Latin America (%) Chile Colombia Mexico Middle East (%) Iran Lebanon UAE Saudi Arabia Africa (%) Algeria Egypt Tunisia 868 (34) 199 211 458 577 (23) 105 181 93 198 1091 (43) 400 434 257
N= 2536 Patients with unavailable data on EF* Patients with EF<45% total population population with EF data available Patients with EF 45% total population population with EF data available 546 (21.5% [19.9-23.2]) 699 (27.6% [25.8-29.3]) (35.1% [33.0-37.3]) 1291 (50.9% [48.9-52.9]) (64.9% [62.7-67.0]) * Not performed within the last 12 months or data unavailable
HF-PSF HF-low EF p-value HF w/o EF data N= 1291 N=699 HF-PSF/HF low EF N=546 Age (y) 64.5 ± 12.4 61.9 ± 12.5 <0.001 65.1 ± 12.5 Male (%) 49.8 72.4 <0.001 58.4 BMI > 30 (%) 39.0 26.7 <0.001 44.1 Abdominal obesity (%) 60.1 41.1 <0.001 51.9 SBP (mmhg) 137 ± 23 123 ± 21 <0.001 138 ± 24 DBP (mmhg) 81 ± 12 75 ± 13 <0.001 82 ± 14 SBP 140 and DBP 90 mmhg (%) 51.1 24.7 <0.001 50.4 HR (bpm) 82 ± 17 83 ± 17 ns 83 ± 17
HF-PSF N= 1291 HF-low EF N=699 p-value HF-PSF/HF low EF HF w/o EF data N=546 Hypertension (%) 78.1 52.9 <0.001 75.1 BP control in hypertensive pts (%) 29.2 49.7 <0.001 29.8 Diabetes (%) 38.6 38.2 ns 37.4 Hypercholesterolemia (%) 48.2 44.1 ns 50.1 Hypertriglyceridemia (%) 28.9 20.8 <0.001 33.5 Smokers (%) <0.001 Former 19.1 30.5 21.8 Current 10.9 15.6 20.3 Alcohol consumption (%) 9.2 11.1 ns 11.9
HF-PSF N= 1291 HF-low EF N=699 p-value HF-PSF/HF low EF HF w/o EF data N=546 PAD (%) 7.8 7.5 ns 7.1 TIA or stroke (%) 6.3 7.6 ns 10.1 COPD (%) 14.2 12.6 ns 17.0 Renal failure (%) Cl Creat <60 ml/min 10.1 15.6 <0.001 10.1 Cognitive decline (%) 2.5 2.7 ns 3.5 Sleep apnea syndrome (%) 4.1 2.6 ns 3.3
HF-PSF N= 1291 HF-low EF N=699 p-value HF-PSF/HF low EF HF w/o EF data N=546 HF Already diagnosed (n) 968 611 <0.001 409 (%) 75.0 87.4 74.9 Duration of HF (%) <1 year 37.1 29.1 <0.001 24.6 1-5 years 46.1 50.1 53.6 > 5 years 15.8 19.0 19.9 Hospitalisation during the previous year (n) 0.8 ± 1.7 1.3 ± 2.2 <0.001 1.0 ± 2.6 NYHA class (%) I 15.9 12.4 <0.001 16.5 II 54.5 48.2 52.9 III 25.9 33.5 26.9 IV 3.7 5.9 3.7 Peripheral oedema (%) 40.8 34.6 0.007 46.5
HF-PSF N= 1291 HF-low EF N=699 HF w/o EF data N=546 Hypertension (%) 73.6 46.3 69.3 CAD (%) 44.1 61.2 43.4 Valvular heart disease (%) 25.0 16.3 18.0 Arrhythmias (%) 22.1 14.5 20.8 Dilated cardiomyopathy (%) 11.0 29.5 19.9 Anemia (%) 6.8 3.0 6.3 Hypertrophic cardiomyopathy (%) 4.7 1.7 10.3 Primary right ventricle failure (%) 3.0 1.3 3.9 Alcohol (%) 1.8 3.2 3.1
HF-PSF N= 1291 HF-low EF N=699 p-value HF-PSF/HF low EF HF w/o EF data N=546 Natremia (mmol/l) 138 ± 4 138 ± 4 ns 139 ± 4 129 mmol/l (%) 1.5 3.5 0.03 2.2 Kaliemia (mmol/l) 4.2 ± 0.5 4.3 ± 0.6 <0.001 4.3 ± 0.6 <3 mmol/l (%) 0.6 0.2 0.8 5.5 mmol/l (%) 1.4 3.2 0.023 3.8 Haemoglobin (g/dl) 12.8 ± 1.9 13.1 ± 2.0 0.02 127 ± 19 Haematocrit (%) 40 ± 6 40 ± 6 ns 39 ± 6 Creatinine Clearance (ml/min) 73 ± 32 74 ± 32 ns 71 ± 29 <30 ml/min (%) 4.4 4.3 4.6 30-60 ml/min (%) 33.3 32.6 ns 34.6 > 60 ml/min (%) 62.4 63.0 60.8 * in patients with available data within the last 12 months
HF-PSF N= 1291 HF-low EF N=699 p-value HF-PSF/HF low EF HF w/o EF data N=546 Chest X Ray* (%) Cardiomegaly** (%) 57.8 77.3 62.2 87.8 ns <0.001 52.2 87.7 ECG* (%) HR** (bpm) LVH investigator ** (%) LAE investigator ** (%) LBB investigator ** (%) Atrial fibrillation** (%) 80.5 82±19 29.5 22.1 12.1 24.2 88.1 85±19 25.6 32.6 28.7 19.6 <0.001 0.002 ns 0.002 - - 64.2 82±17 18.1 28.2 32.3 20.9 Echocaqrdiography: EF (%) LVMI (g/m 2 )* LA diameter (mm) Doppler* (%) E/A ratio** 57.0 ± 9.5 137 ± 53 43 ± 8 45.6 1.0 ± 0.6 32.4 ±7.7 153 ± 49 45 ± 8 38.1 1.5 ± 0.9 <0.001 <0.001 <0.001 - <0.001 Cardiac catheterization* (%) Diastolic dysfunction** (%) LV end diastolic pressure** (mmhg) 12.1 80.8 17.5 ± 6.5 16.9 66.7 20.6 ± 7.8 0.003 0.01 0.01 *Performed during the last 12 months and with available data ** in patients with available data
HF-PSF N= 1291 HF-low EF N=699 p-value HF-PSF/HF low EF HF w/o EF data N=546 Any diet (%) 75.9 85.3 <0.001 70.5 Low sodium* (%) 92.3 93.6 89.0 Diabetic diet* (%) 35.8 33.6 33.9 Lipid Lowering diet* (%) 49.7 49.7 47.5 Low calory diet* (%) 26.6 17.4 20.2 Treatment for smoking cessation (%) 3.9 3.1 ns 3.0 Regular physical exercise (%) 22.6 24.4 ns 17.2 Checking weight once a month (%) 32.3 34.7 ns 25.7 * Among patients with any diet
HF-PSF N= 1291 HF-low EF N=699 p-value HF-PSF/HF low EF HF w/o EF data N=546 Aspirin (%) 66.0 65.2 ns 63.3 Anticoagulants (%) 21.2 27.2 0.003 18.9 Other Antiplatelets (%) 17.5 14.8 ns 12.3 ACE-inhibitors (%) 42.9 63.8 <0.001 51.7 ARB s (%) 45.8 31.2 <0.001 37.4 Loop diuretics (%) 47.6 73.6 <0.001 54.9 Thiazide diuretics (%) 31.8 12.1 <0.001 28.1 Aldosterone antagonists (%) 28.2 51.6 <0.001 28.8 Beta-blockers (%) 58.5 70.7 <0.001 55.2 CCB s (%) 26.3 8.2 <0.001 20.0 Nitrates (%) 25.7 27.4 ns 24.4 Digoxin (%) 20.4 38.5 <0.001 26.8 Amiodarone (%) 11.3 16.1 0.003 14.5 Other antiarrhythmics (%) 1.1 0.7 ns 0.7
In 227 investigators from 10 countries, HF patients represent 15 ± 15% of their total patients 2536 patients with HF were included in the HF study No available data <1year Echocardiography : 21 % of the patients Chest X Ray : 42% ECG : 21% Doppler : 59%
Prevalence of HF-PSF (LVEF 45%) in patients with EF data (n= 1990) is 64.9% [95% CI 62.7-67.0] Patients with HF-PSF (compared with pts with HF and low EF) Are significantly older with a high proportion of women Have higher SBP/DBP Have more frequently a hypertensive or valvular aetiology and a lower frequency of coronary artery disease Have less frequently LVH ACE-inhibitors, loop diuretics, digoxin and betablockers are significantly less prescribed whereas calcium channel blockers and ARB s have a higher prescription rate In this Registry the pharmacologic therapy in both groups (HF-lowEF and HF-PSF) is similar when compared with another international registries (vgr. EHFS-II)
Regional BACKUP results SLIDES (to be presented just in case of specific questions of the auditorium)
Latin America Middle East Africa n=868 n= 577 n=1091 Patients with unavailable data on EF* EF<45% EF 45% 229 (26%) 199 440 84 (15%) 290 203 233 (21%) 210 648 % of patients with EF 45% in the total population 50.7% [47.3-54.1] 35.2% [31.3-39.2] 59.4% [56.4-62.3] % of patients with EF 45% in the population with EF data available 68.9% [65.1-72.4] 41.2% [36.8-45.7] 75.5% [72.5-78.4] * Not performed within the last 12 months or data unavailable
Latin America N=440 Middle East N=203 Africa N= 648 Age (y) 67.9 ± 12.7 62.6 ± 12.1 62.8 ± 11.7 Male (%) 40.0 60.1 53.2 BMI > 30 (%) 30.6 44.2 43.0 Abdominal obesity (%) 59.7 57.7 61.1 SBP (mmhg) 135 ± 21 137 ± 24 139 ± 24 DBP (mmhg) 79 ± 11 81 ± 13 83 ± 13 SBP 140 and DBP 90 mmhg (%) 45.7 53.2 54.2 HR (bpm) 77 ± 14 85 ± 17 85 ± 17
Latin America N=440 Middle East N=203 Africa N= 648 Hypertension (%) 80.2 79. 3 76.2 BP control in hypertensive pts (%) 38.5 27.3 23.1 Diabetes (%) 30.7 45.3 41.8 Hypercholesterolemia (%) 45.7 65.5 44.4 Hypertriglyceridemia (%) 27.1 32.7 28.9 Smokers (%) Former 18.4 22.7 18.5 Current 5.2 19.2 12.2 Alcohol consumption (%) 14.6 11.8 4.7
Latin America Middle East Africa N= 440 N=203 N=648 CAD (%) 30.9 63.1 49.8 MI (%) 16.4 34.0 20.2 Cardiomyopathy (%) 15.5 29.6 17.7 Valvular Heart disease (%) 33.2 31.5 31.2 Congenital heart disease (%) 1.8 0.5 1.1 PAD (%) 3.9 11.8 9.3 Atrial fibrillation (%) 22.0 28.1 33.6 TIA or stroke (%) 3.9 10.3 5.4
Latin America N= 440 Middle East N=203 Africa N=648 COPD (%) 18.9 16.3 10.3 Renal failure (%) Cl Creat <60 ml/min 13.4 14.3 6.5 Cognitive decline (%) 3.6 1.5 2.0 Sleep apnea syndrome (%) 5.0 3.9 3.5
Latin America Middle East Africa N= 440 N=203 N=648 HF Already diagnosed (n) 293 155 520 (%) 66.6 76.4 80.2 Duration of HF (%) <1 year 37.0 42.6 35.5 1-5 years 44.9 35.5 50.0 > 5 years 17.1 21.3 13.3 Hospitalisation during the previous year (n) 0.5 ± 0.8 2.0 ± 3.4 0.6 ± 1.2 NYHA class (%) I 25.5 13.3 10.2 II 59.1 55.2 51.1 III 15.2 27.1 32.9 IV 0.2 4.4 5.9 Peripheral oedema (%) 47.5 40.4 36.4
Latin America N= 440 Middle East N=203 Africa N=648 Hypertension (%) 75.3 75.4 71.9 CAD (%) 29.5 62.1 48.5 Valvular heart disease (%) 23.1 24.6 26.4 Arrhythmias (%) 16.7 21.7 25.9 Dilated cardiomyopathy (%) 10.5 11.8 11.1 Anemia (%) 3.9 11.3 7.4 Hypertrophic cardiomyopathy (%) 4.1 4.9 4.9 Primary right ventricle failure (%) 2.5 3.9 3.1 Alcohol (%) 1.4 4.9 1.1 Thyrotoxicosis (%) 0.2 3.0 4.0
Latin America Middle East Africa N= 440 N=203 N=648 Chest X Ray* (%) 54.1 81.8 52.8 Cardiomegaly** (%) 78.6 67.5 81.3 Pulmonary oedema** (%) 29.0 42.8 48.5 ECG* (%) 77.7 95.1 77.8 HR** (bpm) 78±19 86±19 84±18 LVH SOKOLOV** (%) 14.8 17.3 17.5 LVH CORNELL ** (%) 19.8 21.7 23.9 LVH investigator ** (%) 30.7 39.9 24.8 LAE investigator ** (%) 17.0 33.7 21.2 LBB investigator ** (%) 10.2 15.5 12.1 Atrial fibrillation** (%) 16.4 22.8 30.0 *Performed during the last 12 months and with available data ** in patients with available data
Latin America Middle East Africa N= 440 N=203 N=648 EF (%) 57.8 ± 9.5 52.4 ±7.4 57.8 ±9.7 [45-55[ (%) 41 64 41 55 % (%) 59 36 59 LVESD (mm) 34.0±9.3 42.4±11.2 39.3±10.6 LVEDD (mm) 48.2±9.2 49.3±9.5 51.8±9.9 LV posterior wall thickness (mm) 12.1±2.5 12.5±3.2 10.8±2.3 Ratio LV posterior wall thickness x2 /LVEDD <0.45 (%) 0.45 (%) 34 66 39 61 60 40 LV septum thickness (mm) 12.5±2.6 13.0±3.3 11.4±2.7
Latin America Middle East Africa N= 440 N=203 N=648 LVMI (g/m 2 )* 141 ± 56 144 ± 52 132 ± 51 > 134 g/m 2 in and >110 g/m 2 in (%) 60.7 65.6 54.2 LVMI (g/m 2 )** 129 ± 51 131 ± 49 117 ± 46 > 134 g/m 2 in and >110 g/m 2 in (%) 51.3 50.0 41.3 LVMI (g/height 2.7 ) * 71 ± 29 72 ± 26 65 ± 26 > 50 g/height 2.7 in and >47g/height 2.7 in (%) 76.2 80.5 71.0 LVMI (g/height 2.7 )** 65 ± 26 65 ± 24 57 ± 23 > 50 g/height 2.7 in and >47g/height 2.7 in (%) 71.5 75.0 59.8.0 LA diameter (mm) 42 ± 8 43 ± 9 44 ± 8 *LV mass missing replaced by calculation using Penn definition ** LV mass missing replaced by calculation using ASE definition
Latin America Middle East Africa N= 440 N=203 N= 648 Doppler* (%) 59.1 62.1 47.4 E/A ratio** 0.9 ± 0.5 1.1 ± 0.6 1.0 ± 0.6 E/A 0.75 (%) 42.8 28.1 43.8 EA 0.76 1.49 (%) 48.4 54.4 35.8 EA 1.5 (%) 8.8 17.5 20.4 Cardiac catheterization* (%) 12.0 26.6 7.6 Diastolic dysfunction** (%) 82.7 75.0 85.1 LV end diastolic pressure** (mmhg) 17.4 ± 5.4 20.8 ± 7.8 15.0 ± 5.1 *Performed during the last 12 months and with available data ** in patients with available data
Latin America Middle East Africa N= 440 N=203 N=648 Natremia (mmol/l) 139 ± 4 139 ± 4 138 ± 4 129 mmol/l (%) 1.4 1.8 1.3 Kaliemia (mmol/l) 4.3 ± 0.5 4.2 ± 0.5 4.1 ± 0.5 <3 mmol/l (%) 0.9 0 0.6 5.5 mmol/l (%) 1.4 2.9 0.6 Haemoglobin (g/l) 136 ± 20 127 ± 20 123 ± 17 Haematocrit (%) 42 ± 6 38 ± 6 38 ± 5 Creatinine Clearance (ml/min) 70 ± 34 79 ± 33 72 ± 30 <30 ml/min (%) 6.9 4.3 2.7 30-60 ml/min (%) 36.0 24.1 35.1 > 60 ml/min (%) 57.1 71.6 62.2 * in patients with available data within the last 12 months
Latin America Middle East Africa N= 440 N=203 N=648 Any diet (%) 83.4 77.8 70.2 Low sodium* (%) 92.3 85.3 94.7 Diabetic diet* (%) 29.0 41.0 39.4 Lipid Lowering diet* (%) 57.5 62.8 43.8 Low calory diet* (%) 35.9 17.9 22.0 Treatment for smoking cessation (%) 4.8 5.1 2.9 Regular physical exercise (%) 35.8 15.0 15.9 Checking weight once a month (%) 47.2 36.2 21.0 * Among patients with any diet
Latin America Middle East Africa N= 440 N=203 N=648 Aspirin (%) 61.4 72.3 67.1 Anticoagulants (%) 15.5 17.8 26.1 Other Antiplatelets (%) 14.8 24.8 17.0 ACE-inhibitors (%) 32.6 45.5 49.0 ARB s (%) 56.8 50.5 36.9 Loop diuretics (%) 38.4 58.9 50.2 Thiazide diuretics (%) 31.1 28.7 33.2 Aldosterone antagonists (%) 32.4 26.7 25.8 Beta-blockers (%) 59.1 70.8 54.3 CCB s (%) 25.1 31.2 25.7 Nitrates (%) 13.2 33.7 31.7 Digoxin (%) 19.6 17.3 21.8 Amiodarone (%) 9.8 12.9 11.9 Other antiarrhythmics (%) 1.8 1.0 0.6
Treatments in patients with HF-PSF (2) Latin America Middle East Africa N= 440 N=203 N=648 Oral antidiabetics (%) 23.5 33.2 30.1 Insulin (%) 5.5 11.4 11.6 Statins (%) 42.2 67.8 50.4 Fibrates (%) 8.7 10.4 5.9 Other lipid lowering drugs (%) 3.4 4.0 0.8 Bronchodilators (%) 7.5 12.4 4.0 Corticoids (%) 1.6 3.5 0.8 NSAID s (%) 1.8 0.5 1.4