HF: Alcohol Intake (2007)
Gavazzi A, De Maria R, Parolini M, Porcu M. Alcohol Abuse and Dilated Cardiomyopathy in Men, Am J Cardiol. 2000; 85: 1,114-1,118.
To compare clinical characteristics and long-term outcome between patients with systolic dysfunction, due to alcohol abuse or to an unknown cause in a large series of men prospectively enrolled in a multi-center registry and treated with ACE inhibitors.
Idiopathic dilated cardiomyopathy (IDC).
- Systemic hypertension
- Cor pulmonale
- Left ventricular heart disease
- Sytemic diseases
- Patients with end-stage disease, who were on the heart transplant waiting list.
- Recruitment: Enrollees of a multi-center registry (Italian Multi-Center Cardiomyopathy Study Group-SPIC)
- Design: Prospective cohort.
- Continuous data are expressed as mean±SD
- Student's T-test for unpaired data or the chi-square test was used to assess significant differences between groups
- Paired Student's T-test was used to compare changes at follow-up vs. baseline with groups
- One-way analysis of variance with post-hoc Scheffe's test was used to detect differences among the three groups, according to categorization of alcohol abuse
- Product limit survival was calculated with Kaplan-Meier curves and differences were assessed by the Cox-Mantel test
- SPSS software was used with a P-value below 0.05 being used for significance.
- Timing of measurements: Baseline and the last follow-up available or at the patient's death or transplantation.
- Variable One: IDC was confirmed in every patient at baseline by demonstrating
- Absence of significant coronary artery disease (over 50% luminal diameter reduction of a major coronary artery branch) at coronary angiography
- Absence of specific heart muscle disease or active myocarditis at endomyocardial biopsy
- Reduced left ventricular ejection fraction (under 50%) at contrast left ventricular angiography, radionuclide angiography or echocardiography.
- Variable Two: Death was classified as
- Due to progressive heart failure
- Sudden and unexpected
- Occurring within one hour of new symptoms or during sleep in patients in NYHA Class I to III.
- For follow-up evaluation, left ventricular ejection fraction was serially analyzed by two-dimensional echocardiography from the apical four-chamber view, by the single-plane area-length method. Intra- and interobserver variability was 3±4% and 7±3%, respectively.
- Alcohol consumption was expressed in grams per day and the average total lifetime alcohol intake in kilograms per kg of body weight
- Alcohol abusers had a daily consumption of ethanol either over 80g in the five years before enrollment or over 100g in the two years before enrollment
- They were classified as having stopped (AAS) or continued (AAC) alcohol abuse after entry into the study.
- Initial N: 449 (338 males and 113 females)
- Attrition (final N): 338 (all males)
- Age: 44±12 for IDC and 45±10 for abusers
- Ethnicity: Not described.
- There were significantly fewer non-smokers among the alcohol abusers (P=0.00001)
- Heavy smoking was more frequent among the alcohol abusers (P=0.0001)
- Both groups were similar for NYHA class, presentation of HF, cardiac abnormalities (except ventricular tachycardia) and medications, except for ACE inhibitors (91% IDC vs. 81% abusers; P=0.03) and beta-blockers (34% IDC vs. 9% abusers; P=0.0001).
- During a mean follow-up of 59±35 months, 102 patients died and 45 underwent transplantation. Death was sudden in 50, due to progressive heart failure in 33, unspecific mechanism in nine and was non-cardiac in 10. Mechanisms of death were not different according to alcohol abuse.
- Seven-year transplant-free survival was significantly lower in alcohol abusers (41%) than in patents with IDC (53%, P=0.026) and in alcohol abuse-continued patients (27%) than in either IDC (53%) or alchol abuse-stopped patients (45%). When patients were stratified by baseline treatment, similar differences according to alcohol intake were observed.
- At the last available echocardiographic follow-up assessment (36±24 months), the patient with IDC had beneficial changes in left ventricular function vs. baseline (P<0.001). Among the alcohol abusers, only the alcohol abuse-stopped group subjects had significant improvement in LVEF vs. baseline (P=0.001). The difference remained when the patients were stratified by ACE inhibitor use or non-use of beta-blockers. When alcohol abuse continued, there was no difference in LVEF vs. baseline.
- No significant difference was evident at baseline between the two groups. However, seven-year transplant-free survival was better in patients who abstainded and similar in IDC patients.
- Moreover, in alcohol abuse-stopped, but not in alcohol abuse-continued subjects, LVEF at follow-up increased significantly (similar to patients with IDC), suggesting potential reversibility of ventricular dysfunction, even in established disease.
|Government:||IRCCS Policlinico San Matteo (Spain)|
|University/Hospital:||Istitutodi Fisiologia Clinica CNR, Ospedale San Michelle|
Quality Criteria Checklist: Primary Research
|1.||Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)||Yes|
|2.||Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?||Yes|
|3.||Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?||Yes|
|4.||Is the intervention or procedure feasible? (NA for some epidemiological studies)||Yes|
|1.||Was the research question clearly stated?||Yes|
|1.1.||Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?||Yes|
|1.2.||Was (were) the outcome(s) [dependent variable(s)] clearly indicated?||Yes|
|1.3.||Were the target population and setting specified?||Yes|
|2.||Was the selection of study subjects/patients free from bias?||Yes|
|2.1.||Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?||Yes|
|2.2.||Were criteria applied equally to all study groups?||Yes|
|2.3.||Were health, demographics, and other characteristics of subjects described?||Yes|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||Yes|
|3.||Were study groups comparable?||Yes|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||Yes|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||Yes|
|3.3.||Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)||Yes|
|3.4.||If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?||Yes|
|3.5.||If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)||N/A|
|3.6.||If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?||N/A|
|4.||Was method of handling withdrawals described?||Yes|
|4.1.||Were follow-up methods described and the same for all groups?||Yes|
|4.2.||Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)||Yes|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||No|
|4.4.||Were reasons for withdrawals similar across groups?||N/A|
|4.5.||If diagnostic test, was decision to perform reference test not dependent on results of test under study?||N/A|
|5.||Was blinding used to prevent introduction of bias?||No|
|5.1.||In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?||No|
|5.2.||Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)||No|
|5.3.||In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?||No|
|5.4.||In case control study, was case definition explicit and case ascertainment not influenced by exposure status?||N/A|
|5.5.||In diagnostic study, were test results blinded to patient history and other test results?||N/A|
|6.||Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?||Yes|
|6.1.||In RCT or other intervention trial, were protocols described for all regimens studied?||N/A|
|6.2.||In observational study, were interventions, study settings, and clinicians/provider described?||Yes|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||Yes|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||Yes|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||Yes|
|6.6.||Were extra or unplanned treatments described?||N/A|
|6.7.||Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?||N/A|
|6.8.||In diagnostic study, were details of test administration and replication sufficient?||N/A|
|7.||Were outcomes clearly defined and the measurements valid and reliable?||Yes|
|7.1.||Were primary and secondary endpoints described and relevant to the question?||Yes|
|7.2.||Were nutrition measures appropriate to question and outcomes of concern?||Yes|
|7.3.||Was the period of follow-up long enough for important outcome(s) to occur?||Yes|
|7.4.||Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?||???|
|7.5.||Was the measurement of effect at an appropriate level of precision?||Yes|
|7.6.||Were other factors accounted for (measured) that could affect outcomes?||Yes|
|7.7.||Were the measurements conducted consistently across groups?||Yes|
|8.||Was the statistical analysis appropriate for the study design and type of outcome indicators?||Yes|
|8.1.||Were statistical analyses adequately described and the results reported appropriately?||Yes|
|8.2.||Were correct statistical tests used and assumptions of test not violated?||Yes|
|8.3.||Were statistics reported with levels of significance and/or confidence intervals?||Yes|
|8.4.||Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?||N/A|
|8.5.||Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?||Yes|
|8.6.||Was clinical significance as well as statistical significance reported?||Yes|
|8.7.||If negative findings, was a power calculation reported to address type 2 error?||N/A|
|9.||Are conclusions supported by results with biases and limitations taken into consideration?||Yes|
|9.1.||Is there a discussion of findings?||Yes|
|9.2.||Are biases and study limitations identified and discussed?||Yes|
|10.||Is bias due to study's funding or sponsorship unlikely?||???|
|10.1.||Were sources of funding and investigators' affiliations described?||No|
|10.2.||Was the study free from apparent conflict of interest?||???|