Screening for heart failure in [609465]

181 Mædica A Journal of Clinical Medicine, Volume 2 No.3 2007OOOOORIGINRIGINRIGINRIGINRIGIN ALALALALAL PPPPPAPERSAPERSAPERSAPERSAPERS : : : : : CLINICCLINICCLINICCLINICCLINIC ALALALALAL OROROROROR BBBBBASICASICASICASICASIC RESEARRESEARRESEARRESEARRESEAR CCCCCHHHHHMædica – a Journal of Clinical Medi cine
Screening for heart failure in
individuals with diabetes:
a cross-sectional study
Cornelia BALA, MDa,b; Adriana RUSU, MDb; Cristina NITA, MDa,b;
Ramona STEFAN, MDb; Georgiana NICOLESCU, MDb;
Denise GIURGIUMAN, MDb; Nicolae HANCU, MD, PhDa,b
a„Iuliu Hatieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania
bClinical Center of Diabetes, Nutrition, Metabolic Diseases, Emergency County
Hospital, Cluj-Napoca, Romania
Address for correspondence:Cornelia Bala, MD, Clinical Center of Diabetes, Nutrition, Metabolic Diseases, 2 Clinicilor Str., Zip Code 400006, Cluj-Napoca,Romaniaemail address: [anonimizat]
Objective. Heart failure (HF) is a common and serious co-morbidity of diabetes, because of high prevalence
and poor prognosis. Previous data showed that heart failure is significantly under-diagnosed in the currentpractice from our country. In this study we aimed to determine the prevalence of diagnosed heart failure inindividuals with diabetes and to perform a screening for heart failure, using a method that can be easilyapplied in real-practice conditions.
Method. We conducted a cross-sectional study on an unselected population of patients with diabetes
attending an outpatient clinic. Subjects underwent a complete interview (including symptoms of HF) andclinical exam, followed by a rest ECG. Positive screening for HF (suspected new heart failure) was establishedbased on the combination of positive symptoms (at least two
symptoms- dyspnea, tiredness, or ankle edema)
and significant ECG changes (Q-wave myocardial infarction, left bundle branch block, or left ventricular
hypertrophy).
Results. The study sample consisted of 211 patients with diabetes, with a mean age of 58.8 ±10.2 years;
118 (55.9%) were men, and 199 (94.3%) had type 2 diabetes. Prevalence of previously-diagnosed HF was5.7% and “suspected new heart failure” was identified in 27 (12.8%) of patients in the study group. Whencases with previous diagnosis of HF were added to those identified by the screening protocol, the totalprevalence of HF in our study group was 18.5%. The following factors were found to be significantlyassociated with the presence of “suspected new heart failure”: body mass index (BMI) ≥ 30 kg/m
2 (OR 3.42,
95%CI 1.37-8.58, p=0.008), glomerular filtration rate (GFR) < 60 mL/min/1.73 m < (OR 3.94, 95%CI
1.58-9.79, p=0.003), and presence of hypertension (OR 9.49, 95%CI 1.25-71.9, p=0.029), ischemic heartdisease (OR 3.63, 95%CI 1.58-8.36, p=0.002), atrial fibrillation (OR 7.04, 95%CI 1.34-36.9, p=0.021),peripheral artery disease (OR 5.25, 95%CI 1.10-24.9, p=0.037) and metabolic syndrome (OR 2.54,95%CI 1.02-6.32, p=0.045).
Conclusion . Presence of HF in our study group of patients with diabetes is under-estimated when based
on patients’ history. The active screening for HF, using a simple and accessible protocol for a diabetes out-patient clinic, more than doubles the number of HF cases. This would allow a larger number of patients tobenefit from preventive strategies that might reduce HF-related deaths and hospitalization for exacerbationof HF episodes.
Keywords: diabetes, heart failure, screening

Mædica A Journal of Clinical Medicine, Volume 2 No.3 2007 182SSSSSCREENING FOR H H H H HEART F F F F FAILURE IN IIIIINDIVIDUALS WITH D D D D DIABETES : A CA CA CA CA C ROSS-SSSSSECTIONAL S S S S STUDY
BACKGROUND
Heart failure (HF) is a common
and serious co-morbidity ofdiabetes. Data from theFramingham Heart Studyshowed, over 20 years ago, that
HF was two times as common in diabetic menand five times as common in diabetic womenaged 45-74 years than in age-matched controlsubjects. This association was even stronger inyounger patients (ages ≤65 years), being
fourfold higher in diabetic men and eightfoldhigher in diabetic women than in non-diabeticsubjects (1). More recent studies reportedprevalence of heart failure in individuals withdiabetes ranging from 11.8% in the cohort fromKaiser Permanente Northwest Division (2) andin the Reykjavik study (3) to 22.3% in a cohortof elderly ( ≥ 65 years of age) patients with
diabetes (4). In NHANES-I (National Health andNutrition Examination Survey) EpidemiologicalFollow-up Study, the cumulative incidence ofheart failure at the age of 85 years was foundto be 65.5% in men with diabetes comparedwith 36.9% in men without diabetes, and 61.8%in women with diabetes compared with 28.9%in those without diabetes (5).
Patients with diabetes account for more than
33% of all patients requiring hospitalization forHF (6), and represent about 25% of all patientsenrolled in large-scale clinical trials evaluatingtreatments for HF: 23% in the CooperativeNorth Scandinavian Enalapril Survival Study(CONSENSUS), 25% in Studies of LeftVentricular Dysfunction (SOLVD) trial, 20% inAssessment of Treatment with Lisinopril andSurvival (ATLAS) study, and 27% in RandomizedEvaluation for Strategies of Left VentricularDysfunction (RESOLVD) study (7-10).
Information on the association of diabetes
and heart failure in our country is very limited.In a retrospective study on patients with diabetesadmitted in an in-patient department, theprevalence of previously-diagnosed HF was5.1%. When medical records have beenreviewed for the presence of suggestivesymptoms and objective evidence of cardiacimpairement (ECG, chest X-ray and/or cardiacultrasonography), another 2% of patients havebeen retrospectively diagnosed with HF , resultingin a total prevalence of 7.1% heart failure casesfor in-patients with diabetes. This figure wasconsidered very low for a selected populationwith diabetes, as it is the case with hospitalized
patients, and we concluded that heart failure isclearly under-diagnosed in individuals withdiabetes in current practice (11).
The objectives of the present study are to
determine the prevalence of diagnosed heartfailure in individuals with diabetes and toperform a screening for heart failure, using amethod that can be easily applied in real-practice conditions.
‰
METHODS
We conducted a cross-sectional study on
an unselected population of patients with
diabetes attending the outpatient clinic from the
Clinical Center of Diabetes, Nutrition andMetabolic Diseases of Cluj-Napoca. The sample
size was calculated using the Cochran equation
(12) to obtain a 95% confidence interval of ±5% around a prevalence estimate for heartfailure of 15%, resulting in a number of 196subjects to be included in the study group.
The first 2 patients presenting daily for the
routine visits in the outpatient department and
who accepted study procedures were includedin the study from March 1 to September 1,2007. Patients have been assessed fordemographic characteristics, diabetes history(type and duration of diabetes, diabetic
complications, anti hyperglycemic treatment),
personal history for cardiovascular diseases(including previous diagnosis of heart failure,level of physical activity (low, medium, high),and treatment with cardiovascular medications.Anthropometric parameters (weight, height,
and waist circumference, as well as systolic and
diastolic blood pressure after a 5 minute resthave been measured. Body mass index (BMI)was calculated as weight (kg)/ [height (m)]². Arest 12-leads ECG has been performed in allpatients. Patients underwent a fasting blood
testing for blood glucose, hemoglobin A1c, total
cholesterol, HDL-cholesterol, serum tri-glycerides, and serum creatinine. Micro-albuminuria has been determined from anovernight urine sample in a subset of the studypopulation. Renal dysfunction was assessed by
calculated glomerular filtration rate (GFR):
GFR (mL/min/1.73 m
2) = 186 x (Serum
creatinine)-1.154 x (Age)-0.203 x (1.21 if Black) x
(0.742 if female) (13).
Metabolic syndrome was diagnosed ac-
cording to International Diabetes Federation(IDF) criteria (14).

Mædica A Journal of Clinical Medicine, Volume 2 No.3 2007 183SSSSSCREENING FOR H H H H HEART F F F F FAILURE IN IIIIINDIVIDUALS WITH D D D D DIABETES : A CA CA CA CA C ROSS-SSSSSECTIONAL S S S S STUDY
“Suspected new heart failure” (positive
screening for heart failure) was diagnosed asthe combination of at least two
symptoms
(dyspnea, tiredness, or ankle edema) and oneobjective
evidence of cardiac engagement, as
disclosed by the ECG (Q-wave myocardial
infarction according to MONICA [MonitoringCardiovascular
Disease] criteria, left bundle
branch block, or left ventricular hypertrophy).
Presence of LVH was defined by Sokolow-LyonECG criteria (R wave in V5 through V6+S wavein V1 >35 mm), Cornell voltage criteria (R wavein aVL+ S wave in V3 >20 mm in women or>28 mm in men), or both.
‰
Statistical analysis
SPSS-PC 13.0 (SPSS Inc., Chicago, IL, USA)
package was used for statistical analysis.
To detect significant differences between
variables, t-test was used for normally distrib-uted data, Man-Whitney U test for variableswith abnormal distribution and Fisher’s exacttest for categorical variables. Logistic regressionserved to obtain the odds ratios for factorsassociated with the presence of newly-diagnosedcases of heart failure. All reported P values are
two sided, and a P value <0.05 was considered
to indicate statistical significance.
RESULTS
The study sample consisted of 211 patients
with diabetes, with a mean age of 58.8
±10.2 years; 118 (55.9%) were men, and 199(94.3%) had type 2 diabetes. The maincharacteristics of the study group are shown inTable 1. Men and women had similarcharacteristics, except significantly higher waist
circumference and creatinine levels in men. Aswell, significantly more men are current or ex-smokers.
Use of anti hyperglycemic treatments in
patients with type 1 and type 2 diabetes is shownin Figure 1. From the entire study group, 43.6%
FIGURE 1. Use of anti
hyperglycemic treatmentsamong subjects included inthe study
Data is shown as %; SU,sulphonylureeaTABLE 1. Main characteristics of the study group
Data in table is presented as means±SD, unless specified otherwise;
† Variables with abnormal distribution are presented as median (1st
quartile; 3rd quartile)

Mædica A Journal of Clinical Medicine, Volume 2 No.3 2007 184SSSSSCREENING FOR H H H H HEART F F F F FAILURE IN IIIIINDIVIDUALS WITH D D D D DIABETES : A CA CA CA CA C ROSS-SSSSSECTIONAL S S S S STUDY
of the patients were treated with insulin, alone
or in combination with oral agents. Whenpatients with type 1 diabetes were excluded fromthe analysis, the percentage of insulin-treatedtype 2 diabetes was 40.2%.
Prevalence of specific diabetes complications
was as follows: 28.9% of subjects had diabeticretinopathy, 37% had peripheral diabetic
neuropathy, and 54.4 % had an abnormal
albumin excretion rate ( ≥20 µg/dL in an
overnight urine sample). Renal dysfunction
(GFR< 60 mL/min/1.73m²) was present in 38
patients, representing 18.9% of the study
population.
History of cardiovascular diseases, presence
of other associated conditions (overweight/obesity, dyslipidemia, metabolic syndrome) anduse of cardiovascular medication were obtainedfrom the medical records existing at the
TABLE 2. Use of cardiovascular medications
RAAS, renine-angiotensine-aldosteron system; ACEI,
angiotensine converting-enzyme inhibitor; ARB,angiotensine receptor blocker
FIGURE 2. Prevalence of cardiovascular diseases and associated conditions
Data is shown as %; PAD, peripheral artery disease; IHD, ischemic heart disease; CPD, chronic
pulmonary disease; CHF, congestive heart failure; MetS, metabolic syndromeoutpatient clinic, and were confronted withpatients’ interviews and other medical recordsfrom Cardiology, Neurology or Internal Med-icine departments whenever possible.Prevalence of cardiovascular diseases (includingprevious diagnosis of chronic heart failure) andassociated conditions are shown in Figure 2. 68patients (32.2%) had ischemic heart disease fromwhom 16 patients (7.6% of study group) had ahistory of myocardial infarction. Prior diagnosisof congestive heart failure was found in 12(5.7%) of patients included in the study group.Over 70% of patients had hypertension,dyslipidemia and/or overweight/obesity (definedas a BMI ≥ 25 kg/m²). Metabolic syndrome,
diagnosed according to the InternationalDiabetes Federation set of criteria (14), waspresent in 68.3% of the patients.
Use of cardiovascular medication in the
overall study group is displayed in Table 2. Themost frequently used class of drugs were RAASinhibitors (60.2%), with a relative highpercentage of patients being treated with betablockers (41.2%) and a small number of patientstreated with digoxine (3 patients- 0.5%). Statinsand fibrates are clearly underused (38.9% and16.1% respectively) since over 70% of patientshad been diagnosed with a form of dyslipidemia.
Patients were interviewed for the presence
of dyspnea, tiredness and ankle edema and aphysical examination was performed for thelatter criterian (patients with prior diagnosis of

Mædica A Journal of Clinical Medicine, Volume 2 No.3 2007 185SSSSSCREENING FOR H H H H HEART F F F F FAILURE IN IIIIINDIVIDUALS WITH D D D D DIABETES : A CA CA CA CA C ROSS-SSSSSECTIONAL S S S S STUDY
heart failure were not included). A total of 89
patients (42.2%) had a degree of dyspnea, 92(43.6%) recognized the presence of tirednessat exertion or at rest, and 50 (23.7%) had ankleedema. The combination of at least two of theabove symptoms occurred in 34 (16.1%) ofpatients, which were considered “positive forsymptoms”. Significant ECG changes (Q waveMI, left bundle branch block and/or left ven-tricular hypertrophy) were found in 56 (26.5%)of patients; 21 patients (10.5%) had Q waveMI, 31 (15.6%) had left ventricular hypertrophyand 4 (2%) had both ECG changes.
The combination of positive symptoms and
significant ECG changes was found in 27 (12.8%)of patients in the study group (Figure 3), thesepatients being classified as “positive for heartfailure screening” and representing suspectednew heart failure cases. When cases withprevious diagnosis of HF were added to thosenewly-diagnosed, the total prevalence of HF inour study group was 18.5%.
Variables included in the database were
tested for significance in patients with or without“suspected new heart failure”. The followingfactors were found to be significantly associatedwith the presence of “suspected new heartfailure”: BMI ≥ 30 kg/m², GFR < 60 mL/min/
1.73 m², and presence of hypertension, is-chemic heart disease, atrial fibrillation, peri-pheral artery disease and metabolic syndrome.Odds ratio, 95% CI and statistical significanceare represented in Table 3.
‰
DISCUSSIONS
The prevalence of previously-diagnosed heart
failure in our study population was 5.7%,
very low when compared with the data fromthe literature: 11.8% in the cohort from KaiserPermanente Northwest Division (2) and in theReykjavik study (3) and 22.3% in a cohort ofelderly (≥ 65 years of age) patients with diabetes
(4).
Studies on heart failure in individuals with
diabetes had different methods to assessing thepresence of heart failure which are importantwhen comparing prevalence data.
In the study of Nichols et al (2), the prev-
alence of HF was based on the presence of ICD-9-CM (Intenational Classification of Diseases,Ninth Revision, Clinical Modification) diagnosiscodes for heart failure in an unselectedpopulation of over 9,000 patients with type 2FIGURE 3. Combined findings of patients “positive for
symptoms” and “with significant ECG changes”. Data isshown as number of patients in each category
Legend Figure 3:(-) symptoms , negative for symptoms e.g. one or no symptoms for HF
(dyspnea, tiredness, or ankle edema)(+) symptoms , positive for symptoms e.g. at least two
symptoms (dyspnea,
tiredness, or ankle edema)(+) ECG , significant ECG changes e.g. Q wave MI and/or left ventricular
hypertrophy(-) ECG , one or none of the following: Q wave MI and left ventricular
hypertrophyMI, myocardial infarction
TABLE 3. Factors associated with “suspected new
heart failure” in logistic regression models, adjusted forage and sexdiabetes who were older (mean age 64.2 years),but with less hypertension (52.5 vs 77.7%) andischemic heart disease (25.1 vs 32.2%), less useof insulin (19.7 vs 43.6%), and similar levels ofA1c, systolic and diastolic blood pressure whencompared with our study population. Thereported prevalence of HF was 11.8%, almostdouble than in our study, which includedhigher-risk patients in terms of presence ofischemic heart disease, hypertension and useof insulin; this data confirms that in our

Mædica A Journal of Clinical Medicine, Volume 2 No.3 2007 186SSSSSCREENING FOR H H H H HEART F F F F FAILURE IN IIIIINDIVIDUALS WITH D D D D DIABETES : A CA CA CA CA C ROSS-SSSSSECTIONAL S S S S STUDY
population with diabetes, HF is significantly
under-diagnosed.
In NHANES I Epidemiologic Follow-up Study
(5) prevalent heart failure was defined as “ever
being told by a physician that they have hadheart failure or having used medications for a
weak heart during 6 months before baseline
interviews”, and incident heart failure wasconsidered if the patient had a discharge
diagnosis or a death certificate with the ICD-9
(International Classification of Diseases, NinthRevision) code of 428.0 to 428.9. The study did
not report data on prevalence of heart failure in
patients with diabetes, as did our study.
Reykjavik study (3) was a population-based
cohort study which recruited
19,381 participants
aged 33–84 years over a 30-year period (1967-1997) who were followed
until 2002 and
examined the prevalence of HF according to
categories of glucose tolerance. Cases weredefined in accordance
with World Health
Organization criteria for type 2 diabetes or
abnormal glucose regulation (impaired glucosetolerance or impaired fasting glucose)
and
European Society of Cardiology guidelines for
heart failure (15), but considering the outcomeof ECG or chest X-ray as objective evidence for
cardiac dysfunction, and not echocardiogram
(because of limited availability of the lattermethod). The investigators of the Reykjavik study
recognized that there is a risk for false-positive
and -negative diagnosis. However,
in the
Framingham Study, signs of cardiac dysfunction,
such as heart enlargement on chest X-ray and
left ventricular hypertrophy on ECG, were highly
predictive for deteriorating cardiac function (16).
Moreover, only 8–15% of asymptomatic people
with hypertension, diabetes, coronary artery
disease, or previous myocardial infarction had
systolic dysfunction when screened with
echocardiography (17).
We chose to further modify the protocol used
in the Reykjavik study, considering that chest X-
ray is less accessible for an out-patient diabetesclinic. In order to increase the sensitivity of ECG
changes, we diagnosed left ventricular
hypertrophy (LVH) as the presence of Sokolow-Lyon ECG criteria (R wave in V5 through V6+S
wave in V1 >35 mm), Cornell voltage criteria (R
wave in aVL+ S wave in V3 >20 mm in womenor >28 mm in men), or both. These criteria have
been chosen according to a recently publishedstudy (18) which showed that in 3074 patients
with LVH as determined by echocardiogram,
978 (31.8%) met both LVH criteria, 1244
(40.5%) met Cornell criteria only, and 852
(27.7%) met Sokolow-Lyon criteria only.
The prevalence of HF in the subgroup of
subjects with diabetes in the Reykjavik study was
12%, compared with 18.5% in our study which
did not use chest X-ray as an objective sign of
cardiac impairment, but only ECG changes.
Nevertheless, it must be noted that some
patients in the Reykjavik study had been
diagnosed with diabetes during the study,
according to oral glucose tolerance test or fasting
blood glucose, while in our study group we
included patients with known diabetes, having
a median duration of 5 years.
Factors associated with prevalent and
incident HF in the study of Nichols et al. were
age, duration of diabetes, insulin treatment,
ischemic heart disease, and high levels of serum
creatinine (2). Other studies reported that
nephropathy, peripheral artery disease (4),
urinary albumin excretion, hemoglobin A1c
(19), or fasting blood glucose (20) are factors
associated with HF in individuals with diabetes.
In our study, we found that ischemic heart
disease, hypertension, presence of metabolic
syndrome, atrial fibrillation, peripheral artery
disease, obesity (BMI ≥ 30 kg/m²) and renal
impairment (GFR< 60 mL/min/1.73 m²) are the
factors statistically associated with new cases of
heart failure. Age, duration of diabetes and use
of insulin were not significantly associated with
the presence of suspected new heart failure in
our study group. Higher odds ratio and broader
95% CI obtained in our analysis as compared
with other studies are explained by a weaker
statistical power of our study group, which was
originally designed only to determine the
prevalence of HF in a cohort of patients with
diabetes.
LIMITATIONS OF THE STUDY
The main limitation of the study was the use
of ECG as the only objective sign of cardiac
engagement and not chest X-ray, echocar-diogram or natriuretic peptides, with the risk offalse-positive diagnosis. Therefore, the resultsshould be interpreted as a screening outcome thatneeds further confirmation of HF diagnosis.
‰

Mædica A Journal of Clinical Medicine, Volume 2 No.3 2007 187SSSSSCREENING FOR H H H H HEART F F F F FAILURE IN IIIIINDIVIDUALS WITH D D D D DIABETES : A CA CA CA CA C ROSS-SSSSSECTIONAL S S S S STUDY
Conclusion
Presence of HF in our group of patients with diabetes is
under-estimated when based on patients’ history. The activescreening for HF , using a simple and accessible protocol for adiabetes out-patient clinic, more than doubles the numberof HF cases. This would allow to a larger number of patientsto benefit from preventive strategies that might reduce HF-related deaths and hospitalization for exacerbation of HFepisodes.
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