Cardiovascular assessment of asymptomatic patients with juvenile-onset localized and systemic scleroderma: 10 years prospective observation.

OBJECTIVES: The aim of the present study was non-invasive evaluation of the cardiovascular system in asymptomatic young adult patients with juvenile localized scleroderma (JLS) and juvenile systemic sclerosis (JSS). METHODS: A group of 34 consecutive children with scleroderma were prospectively observed in the study. The control group (CG) consisted of 20 healthy subjects. In each subject 12-lead electrocardiographic, echocardiographic, ECG Holter, and ambulatory blood pressure monitoring examinations were performed at the baseline visit and after 10 years. Additionally, B-type natriuretic peptide (BNP) concentrations were measured after 10 years. RESULTS: Examinations were performed in 13 patients with JLS and 15 with JSS at the final visit. Two children had died (one from each group). Four patients were alive but refused the final visit. After 10 years, a higher prevalence of ventricular extrasystoles (p = 0.01) and an elevated pulmonary arterial pressure (JLS: p = 0.04, JSS: p = 0.03) were observed in both groups, but in comparison with the controls there was no significant difference at the final visit. In JLS patients more cases of left ventricle diastolic dysfunction, hypertension, and sinus tachycardia were diagnosed at the final visit (p ≤ 0.05). More atrioventricular block episodes in both groups of scleroderma patients were observed. Over the 10 years, arterial hypertension was diagnosed in three patients from the JLS group and in two with JSS. There were no significant differences in BNP concentrations at the final visit. CONCLUSIONS: The results of the present study show that juvenile scleroderma seems to be more benign than adult-onset disease. This observational study shows subclinical, not severe, cardiac abnormalities in adult patients with juvenile-onset disease.

Computed tomography with positron emission tomography is more useful in local than systemic infectious process related to cardiac implanted electrotherapy device: a prospective controlled multicenter diagnostic intervention PET-Guidance Trial.

Assess the diagnostic value of 18-F FDG PET/CT in cardiac implantable electronic devices (CIED) infections in facilitating diagnostic process and optimizing decision-making process.Study group (n = 21) patients with initial suspected diagnosis of CIED-related infection or fever of unknown origin and patients referred for device removal due to infection. Control group (n = 13) patients with implanted CIED, who underwent PET/CT due to other non-infectious indications and had no data for infectious process in follow-up.PET/CT scan showed pocket infection in 12 patients (including 1 in whom infection was not finally diagnosed-the examination was performed early after the implantation procedure-1.5 months), increased tracer uptake in intravascular lead part in 3 patients, and increased uptake in intracardiac part in 5 patients.We found that sensitivity, specificity, positive predictive value, and negative predictive value of the diagnosis made by PET/CT in generator pocket infection was 91.7%, 70%, 78.6%, 87.5% and in lead-dependent intracardiac infection 100%, 47.1%, 35.7%, 100% respectively. PET/CT scan enabled reclassification of diagnosis from possible to definite CIED-related infection in 6 out of 9 patients, and to excluded in 3 out of 9.Establishing diagnosis of device related infections may be challenging due to non-specific symptoms. Incorporation of PET/CT scan in the diagnostic schema can improve accuracy and timing of the diagnosis and help to assess the extent of infection. PET/CT is more useful in local than systemic infectious process related to cardiac implanted electrotherapy device.Trial registration Consent of the bioethics committee nr IK-NP.-0021-85/1465/14. Registration in the www.clinicaltrials.gov database: NCT02196753.

Pericardial effusion after intravenous recombinant tissue-type plasminogen activator for acute myocardial infarction.

The effect of thrombolytic therapy on the frequency, time course and sequelae of pericardial effusion after myocardial infarction are unknown. A prospective, serial, 2-dimensional echocardiographic study of patients with myocardial infarction who received recombinant tissue-type plasminogen activator (rt-PA) was undertaken to address this issue. The study population comprised 52 of the 112 patients enrolled in the first Thrombolysis and Angioplasty in Myocardial Infarction trial at Duke University Medical Center. Enrollment in the serial echocardiography protocol was determined by equipment and support staff availability. Complete echocardiographic studies were performed within 90 minutes after initiation of thrombolytic therapy (day 0), and on days 1, 3 and 6. Patients undergoing serial echocardiography did not differ in demographic or clinical characteristics from those who did not. Pericardial effusion was present in 3 of 38 patients (8%) at day 0, in 2 of 44 (5%) at day 1, in 8 of 43 (19%) at day 3, and in 10 of 42 (24%) at day 6. By day 6, 3 of 10 pericardial effusions were moderate in size, 1 of 10 was large and the remainder were small. No patients developed echocardiographic or hemodynamic signs of cardiac tamponade. The prevalence and time course of pericardial effusion among patients with acute myocardial infarction who received rt-PA in this study are similar to observations reported in earlier studies in which patients did not receive thrombolytic therapy. Adverse sequelae of pericardial effusion after thrombolytic therapy are rare.

Efficacy of trimetazidine in patients with recurrent angina: a subgroup analysis of the TRIMPOL II study.

OBJECTIVES: The revascularization procedures become more and more popular to treat coronary artery disease, in many countries. Some patients are free of angina after revascularization, without any documented re-stenosis present with recurrent angina symptoms after a period of time. The aim of this work was to assess the efficacy of trimetazidine in the subpopulation of patients with a history of PTCA or CABG, who were included in the TRIMPOL II study. METHODOLOGY: A subgroup of 94 patients was retrospectively analysed from the TRIMPOL II study, a multicentre, double-blind randomised placebo-controlled trial in 426 patients with stable effort angina. These patients have a history of revascularization for coronary artery disease, and they are still symptomatic after 6 months despite a treatment with metoprolol (50 mg twice daily). They were randomly allocated to receive either trimetazidine (20 mg 3 times daily) or placebo for 12 weeks, on top of the beta-blocker. Exercise test parameters, clinical efficacy and safety were assessed. Results were analysed using the Student test, the Mann-Whitney test or the Shapiro-Wilk test. RESULTS: Compared to placebo, the 12-week treatment with trimetazidine significantly improved: time to 1 mm ST segment depression (385.1 s +/- 144.6 s versus 465.0 s +/- 143.8 s [p < 0.01]); exercise test duration (466.9 s +/- 144.8 s versus 524.4 s +/- 131.5 s [p = 0.048]), total workload (9.0 m.e. +/- 2.4 m.e versus 10.1 m.e. +/- 2.4 m.e [p = 0.035]) as well as time to onset of angina (433.6 s +/- 164 s versus 508.1 s +/- 132.4 s [p = 0.031]). Weekly number of angina attacks and nitrate consumption were significantly reduced in the trimetazidine group when compared to placebo. Three mild gastro-intestinal side-effects were reported in the trimetazidine group. CONCLUSION: These results show that trimetazidine provides anti-anginal efficacy in post-revascularized patients with recurrent angina despite a monotherapy with metoprolol. The treatment was well accepted.

Advantages of exercise echocardiography in comparison to dobutamine echocardiography in the diagnosis of coronary artery disease in hypertensive subjects.

OBJECTIVE: The aim of the study was to compare the efficacy and safety of two stress echocardiography methods, exercise and dobutamine, in the diagnosis of coronary artery disease in hypertensive patients with angina. PATIENTS AND METHODS: A total of 197 treated hypertensive patients, age 53 +/- 9 years (65 women) with no history of myocardial infarction referred for coronary angiography were prospectively investigated with exercise electrocardiography (ECG), exercise and dobutamine echocardiography. RESULTS: Sensitivity of the exercise ECG, exercise echocardiography and dobutamine echocardiography did not differ (77%, 82% and 75%). Negative predictive value of exercise ECG was significantly lower than exercise echocardiography (64% vs 79%, P < 0.01). Specificity and positive predictive value of exercise ECG were markedly lower than exercise and dobutamine echocardiography (57%, 96%, 98% and 72%, 97%, 98%, P < 0.0001 for both stress echocardiography vs ECG). Specificity and sensitivity of diagnostic methods were not influenced by the presence of echocardiographic left ventricular hypertrophy. Dobutamine infusion in comparison to exercise was more often associated with substantial arterial blood pressure rise or fall (7% vs 2%, P < 0.05) and with simple ventricular ectopy (15,7% vs 6,1%, P < 0.05). CONCLUSIONS: In hypertensive patients with the symptoms of angina, both stress echo methods are significantly more specific than the exercise ECG test. Maximal exercise is associated with less frequent side effects than infusion of dobutamine, so exercise echocardiography may be preferred in the diagnosis of angina in hypertensive patients.

Anti-ischaemic efficacy and tolerability of trimetazidine administered to patients with angina pectoris: results of three studies.

Several clinical studies have compared the anti-ischaemic properties of trimetazidine used as monotherapy with those of standard anti-anginal therapy. In the treatment of uncontrolled angina pectoris, the addition of a metabolic agent such as trimetazidine to existing therapy with a haemodynamic agent would appear to confer advantages over the addition of a second haemodynamic agent. Here we report the results of three studies conducted in Poland, the Czech Republic and Hungary that provide additional evidence for the beneficial effects of combining trimetazidine with a conventional haemodynamic agent such as beta-blockers, long-acting nitrate or calcium channel blockers. This combination provided significant benefits in terms of improved exercise capacity and decreased number of angina attacks along with a good tolerability profile.

Resolution of an aortic mobile mass with anticoagulation without evidence of arterial embolism.

The prognostic significance of aortic mobile debris detected by transesophageal echocardiography (TEE) in patients without history of embolism has not been established. A mobile aortic arch mass was found by TEE in a 59-year-old man with coronary artery disease, and with rheumatic mitral valve disease, and with no embolic symptoms. The patient was anticoagulated for 6 weeks and the mass was no longer seen on repeated TEE. He had no embolic symptoms during 9 months of follow-up. Different therapeutic approaches to mobile aortic debris are discussed and anticoagulant treatment of asymptomatic cases is advocated.

Working women are better responders to beta-blocker monotherapy of mild hypertension than men.

The aim of this single-blind study was to compare the efficacy of betaxolol treatment (20 mg/day) on 24-h blood pressure profiles in working men and women with mild hypertension (grade 1 acc. ESH/ESC/JNC 2003), A group of 11 men and 11 women with a mean age 47+/-5 years underwent 24-h blood pressure monitoring after 8 days of placebo and after 20 days of treatment. A significant reduction (p < 0.05) in blood pressure was found for 11 h in men and 15 h in women (systolic) and 9 h in men and 13 h in women (diastolic). There was a tendency for a greater mean reduction in women (9.6/8.0 mmHg in men versus 12.9/7.4 mmHg in women). Diastolic blood pressure variability was significantly reduced in women (9.9 versus 13.1, respectively, p < 0.002) with a tendency for systolic blood pressure variability reduction (13.0 versus 15.1). The smoothness index for systolic blood pressure was higher in women (1.0/0.74 versus 0.64/0.61). A better response for betaxolol treatment 20 mg/day was observed in women in terms of target organ damage: a longer period of significant blood pressure reduction, lower variability and a tendency toward a greater reduction.

[Echocardiographic image of cardial amyloidosis]. / Obraz echokardiograficzny amyloidozy serca.

Heart is involved nearly in 90% of acquired, systemic amyloidosis in a course of plasmocytoma, monoclonal gammapathy, Waldenstrom's disease and others immunological disorders. In classical acquired systemic amyloidosis due to chronic bacterial infection and other inflammatory states heart involvement is observed in 54% of patients. Authors presented a case of cardiac amyloidosis coexisting with hepatomegaly and nephropathy due to plasmocytoma. Diagnosis was based on the echocardiographic examination to which the patient was sent as the unstable postinfarction angina. Echocardiographic image typical of amyloidosis revealed such changes as: concentric both ventricular hypertrophy, generalized contractility impairment, thickness of intraatrial septum and pericardium with minimal effusion. Echocardiographic diagnosis was proved by the anatomopathologic examination.

[Prognostic value of QT-QS2 index in the assessment of sudden coronary death]. / Wartosc prognostyczna wskaznika QT-QS2 w ocenie wystepowania naglych zgonów w chorobie wiencowej.

200 patients aged 49 +/- 8 with coronary artery disease underwent selective coronarography, left ventriculography as well as performed every year laboratory, polycardiography, ECG exercise test, 24-hour ECG Holter monitoring and X-ray chest examinations. Mean follow-up period was 34 +/- 10 months. For QT-QS2 index monitoring patients were divided into two groups: I--with abnormal index QT greater than QS2 (61-30%) and II--with the normal one QT less than QS2 (139-70%). Lown's classification was applied for ventricular premature beats assessment. Left ventricular contractility was estimated in hemodynamic examination. 28 patients died due to cardiac reasons during follow-up (14%). Among 19 suddenly died patients (9.5%) 7 had a normal and 12 an abnormal QT-QS2 index. Sudden mortality rate was 5% in the normal QT less than or equal to QS2 subgroup, and 20% in the abnormal QT greater than QS2 one. These differences are statistically significant.

[Value of two-dimensional and Doppler echocardiography in the diagnosis of rupture of the interventricular septum in myocardial infarction]. / Wartosc echokardiograffii dwuwymiarowej i dopplerowskiej w diagnostyce chorych z peknieciem przegrody komorowej w przebiegu zawalu serca.

Usefulness of two-dimensional and Doppler echocardiography in diagnosis of the ruptured interventricular septum in a course of myocardial infarction was evaluated basing on own material consisted of 6 cases. Ventricular septal defect was visualized in 5 patients. The blood flow through the ventricular septum was detected in all of 6 patients. Obtained results were concordant with intraoperative and anatomicopathologic findings as for as the localization of the rupture is concerned.

[Sensitivity of exercise echocardiography, electrocardiographic exercise test and 24-hour ekg monitoring in diagnosing and evaluating the efficacy of coronary disease treatment]. / Znaczenie wysilkowej echokardiografii, elektrokardiograficznej proby wysilkowej i 24-godzinnego monitorowania EKG w rozpoznaniu i ocenie skutecznosci leczenia choroby wiencowej.

To test the sensitivity and specificity of noninvasive tests for detecting myocardial ischemia, 78 patients undergoing cardiac catheterisation for suspected coronary artery disease (CAD) were studied in prospective blinded manner with exercise echocardiography (EE), ecg stress test (ET) and 24-hour Holter monitoring for analysis of ST-segment changes (HM). All noninvasive tests were repeated after one year follow-up period. Exercise was performed in a supine position using a bicycle ergometer. Real time 2-DE examinations were performed in the left lateral position: at rest, at the peak of exercise and immediately after exercise testing. The sensitivity and specificity of EE, ET and HM for detection of CAD were: 76%, 92%; 90%, 48%; and 80%, 71% respectively. In a group of 48 pts with the narrowing of coronary artery (CA) < 50%, the follow-up EE was negative in 45. In a group of 30 pts with significant narrowing of CA, 10 were asymptomatic within one year after PTCA or CABG; in 9 of them the follow-up EE as well as ET were negative. HM less correlated with clinical course in asymptomatic subjects: in 4 patients it was negative and in 6 - positive. The reminding 20 patients with CAD treated medically, with PTCA or CABG were symptomatic after one year. The follow-up EE, ET and HM studies were positive in 17, 19 and 17 cases respectively. We conclude that sensitivity of EE in diagnosis of CAD is comparable to ET and HM, but its specificity is higher.(ABSTRACT TRUNCATED AT 250 WORDS)

[Cor triatriatum with mitral incompetence--contribution to diagnosis and therapy]. / Serce trójprzedsionkowe z niedomykalnoscia zastawki dwudzielnej--przyczynek do diagnostyki i terapii.

Authors presented difficulties in diagnosis of the cor triatriatum with the mitral incompetence in 34 years old female patient. Diagnosis was based on two-dimensional and doppler echocardiographic examinations and then angiocardiographically proved. Therapy consisted in resection of the fibromuscular intraatrial septum and implantation of the St. Jude mitral prosthetic valve.

[Localization of myocardial infarction with the help of EKG and two-dimensional echocardiography. Controversies]. / Lokalizacja zawalu serca za pomoca ekg i echokardiografii dwuwymiarowej. Kontrowersje.

A multicentre study of the localization of myocardial infarction (MI) using ECG and 2-dimensional echocardiography (Echo-2D) was performed on the 21st day of the onset of MI. The study population consisted of 650 pts (mean age 55.0 years), 553 males and 97 females. The purpose of the study was: 1) to compare the site of MI as diagnosed by ECG and Echo-2D, 2) to determine the controversies in the diagnosis between these two methods. Consistent results of both methods were obtained in 408 pts (62.8%) of the group. In 61 pts (9.4%) the diagnosis of MI by ECG and Echo-2D was undefined. In 181 pts (27.8%) the inconsistencies of ECG and Echo-2D evaluations were demonstrated; in 106 pts ECG changes were undefined, but evident Echo-2D changes were found; on the contrary, in 51 pts MI diagnosed by ECG was not confirmed by Echo-2D. In 24 pts entirely inconsistent results were shown. 209 pts (32%) with myocardial contractility disorders in the apical region of the heart diagnosed by Echo-2D showed different MI localisation as determined by ECG: 147 pts had anterior or antero-lateral MI, 28 pts--postero-inferior MI, 12 pts--apical MI and 22 pts--another one. By these findings it has been shown that ECG and Echo-2D are compatible methods but not replaceable ones.

[Efficacy and tolerance of trimetazidine, a metabolic antianginal, in combination with a hemodynamic antianginal in stable exertion angina. TRIMPOL I, a multicenter study]. / Efficacité et tolérance de la trimétazidine, antiangoreux métabolique, en association avec un antiangoreux hémodynamique dans l'angor d'effort stable. TRIMPOL I une étude multicentrique.

OBJECTIVE: Assess the antianginal and anti-ischemic effect of trimetazidine in patients with stable exercise-induced angina insufficiently controlled with conventional antianginal drugs. PATIENTS AND METHODS: The study population included patients with coronarographically documented stable exercise-induced angina and no other serious concomitant condition. For inclusion, patients had to have two comparably positive treadmill exercise tests. Conventional antiangina drugs (long-acting nitrate derivatives, beta-blockers or calcium antagonists) were continued as was any other therapy having no effect on the ECG ST segment. The patients were given a 4-week regimen of trimetazidine (20 mg t.i.d.) after the second positive treadmill test and final inclusion. At the end of this period, a final exercise test was performed. The study population included 700 patients (mean age 54 +/- 8.4 years, range 32-71 years, 615 men, 85 women) who completed the entire treatment protocol. RESULTS: The main findings observed after 4 weeks of treatment with trimetazidine were: significant lengthening of the total duration of exercise (486.6 s versus 443.7 s, p < 0.01)), increase in total work (10.6 METS versus 9.4 METS, p < 0.01), significant lengthening of delay to 1 mm ST depression (389.9 s versus 337.8 s, p < 0.01) and of the delay to onset of angina (450.3 s versus 251.7 s, p < 0.01). The other results were a significant reduction in the number of daily episodes of angina (2.47 versus 3.66, p < 0.01) and a reduction in mean use of complementary trinitrine (1.8 versus 2.94, p < 0.01). CONCLUSIONS: Four weeks of treatment with trimetazidine in combination with conventional antiangina drugs leads to a longer delay to development of 1 mm ST depression (ischemia threshold), significant lengthening of total duration of treadmill exercise, increased total work, and longer delay to angina theshold. Clinically, there was a reduction in the mean number of episodes of angina and a reduction in the use of trinitrine.

[ECHO image quality of the left ventricle during dobutamine stress echocardiography]. / Jakosc obrazu echokardiograficznego w czasie testu obciazeniowego z dobutamina.

This study aimed at assessing ECHO image quality of the left ventricle during dobutamine stress echocardiography (ED). The study involved 582 patients without previous myocardial infarction. Their age ranged from 27 to 74 years, mean age 52 +/- 9. Dobutamine was given in stepwise increasing doses from 5 to 40 mcg/kg per minute. Atropine was added in 253 (43%) cases. The wall motion asynergy was evaluated by left ventricular echo image divided into 16 segments. At least one segment has not been visualised in 5.5% of patients. At the peak dose of administrated dobutamine (> 20 mcg/kg per minute) it increased to 6.1%. Unvisualized segments did not impair the test and did not affect negative or non diagnostic results, as was verified statistically. Patients' age, body weight and BMI did not exert a significant effect on the quality of echo image. Segments 5 and 11 were seen constantly during the whole test. Segment 13 was poorly visualised during the tests. Only in 1.5% of patients peak dose of dobutamine deteriorated the image, especially in segments 1, 3, 6, and 12. During the dobutamine echocardiography test the quality of ECHO image of left ventricular wall was worsening only in a few patients. It was not considered the reason of test interruption and did not impared the results of ED.

[Evaluation of antiarrhythmic efficacy of sotalol in various doses in patients with ventricular tachyarrhythmias]. / Ocena skutecznosci przeciwarytmicznej sotalolu w róznych dawkach u chorych z komorowymi zaburzeniami rytmu.

UNLABELLED: Antiarrhythmic efficacy of sotalol--noncardioselective beta-adrenergic blocking agent with class III antiarrhythmic action was evaluated in 34 patients [pts] (mean age 55 +/- 11) with chronic ventricular arrhythmias and coronary artery disease, 38% with previous myocardial infarction. Two schedules of dosing were tested: 3 x 80 mg and 2 x 160 mg during 28 days of therapy. Pts with Lown class II and IV arrhythmia derived from 24-hours Holter recording were assigned. Ventricular premature complexes [VPCs] and couplets reduction by 80% and total elimination of runs defined antiarrhythmic efficacy. Proarrhythmia was defined by four times increase in VPCs, ten times increase in couplets and runs or sustained VT episodes. RESULTS: Antiarrhythmic efficacy of two doses of sotalol according to study criterion was: 31% for lower dose (3 x 80 mg) and 24% for higher dose (2 x 160 mg). Overall efficacy for both doses was 55%. According to Morganroth criterion, lower dose was effective in 29% pts and both doses, lower and higher, in 41% pts. According to other commonly used criterion: 70% VPCs reduction, 90% couplets reduction and total elimination of runs, lower dose of sotalol was effective in 32% pts and both doses in 47% pts. Significant reduction of heart rate and prolongation of QT and QTc were observed. In 3 pts QT was prolonged over 500 ms. Proarrhythmia according to Velebit criterion was suspected in one patient after one week of 3 x 80 mg teratment which caused premature cessation of therapy. No significant abnormalities in laboratory values were observed. CONCLUSIONS: Antiarrhythmic efficacy of sotalol was comparable to other studies. Its value in pts with malignant ventricular tachyarrhythmias: sustained ventricular tachycardia and ventricular fibrillation requires further studies with higher number of patients.

[Side effects during dobutamine stress echocardiography: analysis of 582 studies]. / Objawy niepozadane echokardiograficznej próby dobutaminowej--analiza 582 badan.

The purpose of the study was to assess the safety, adverse effects and complications of the dobutamine stress echocardiography (ED). 582 patients without previous infarction were prospectively studied with ED. There were 196 female and 368 male, age varied from 27 to 74 years, mean 52. Dobutamine was given in stepwise increasing doses from 5 to 40 mcg/kg/min. Mean maximal dose achieved was 33 mcg/kg/min. Atropine was added in 253 (43%) cases. Significant coronary artery disease was present in 323 patients (53%). There were no death, no myocardial infarction or episodes of sustained ventricular tachycardia as a result of ED. The test was terminated when following conditions were revealed: target heart rate (28.9%), maximal established dose achieved (25.3%), left ventricular asynergy (19.6%), angina pectoris (10.8%), increase of systolic blood pressure above 220 mm Hg (2.6%), hypotension (7.6%), nonsustained ventricular tachycardia (1.7%). The most common non-cardiac side effects were skin tingling (19.8%), atypical chest pain(16.3%), palpitations (13.9%) and headache (7.9%). The most side effects were usually well tolerated, without the need for test cessation. The ED was terminated only in 4 (0.6%) patients because of non-cardiac side effects including nausea (0.3%) and headache (0.3%). We conclude that ED may be safely performed in routine clinical practice. Side effects were rare and usually minor. Most severe ischemic pain was relieved by test interruption and sublingual nitro-glycerine or short acting beta-blocker administration.

Regression of left ventricular hypertrophy in hypertensive patients after 1 year of treatment with rilmenidine: a double-blind, randomized, controlled (versus nifedipine) study.

OBJECTIVE: To assess the effect of 1-year treatment with rilmenidine, an oxazoline compound that exerts its antihypertensive effects through binding to imidazoline receptors in the brainstem, on left ventricular hypertrophy (LVH) secondary to essential, mild-to-moderate hypertension [supine diastolic blood pressure (DBP)95-115 mmHg]. METHODS: We performed a double-blind, randomized, controlled (versus slow-release nifedipine) trial. Adjustment of treatment took place every month (M) between inclusion (MO) and an evaluation after 6 months (M6), then during M9 and after 1 year (M12) to achieve supine DBP values < or = 90 mmHg. Patients were dropped from our study if they had DBP> 95mmHg during two consecutive visits or DBP>115 mmHg on one occasion. The daily dosage of rilmenidine was 1 mg, and could be increased to 2 mg/day. The daily dosage of slow-release nifedipine was started from the beginning at the maximum dosage of 40 mg/day, so that there was no true adjustment of treatment despite the allocation of patients to a different unit in the case of DBP> 95 mmHg. The primary criterion was the change in left ventricular mass index (LVMI, g/m2), assessed by echocardiography, between MO and M12 for patients who completed the trial. RESULTS: After a 1-month placebo run-in period, 76 patients were selected and 73 were included (35 treated with rilmenidine and 38 treated with nifedipine). Fifteen patients withdrew from the study and two completed the study with a major deviation from protocol, leaving 56 patients (24 treated with rilmenidine and 32 treated with nifedipine) for a per-protocol analysis. Baseline demographic characteristics and history of arterial hypertension for the rilmenidine and nifedipine groups were similar, for included patients and for those taken into account for the per-protocol analysis. Between MO and M12, DBP in members of the per-protocol population was adequately controlled for those in the rilmenidine group (102.7+/-4.6 versus 88.5+/-7.1 mmHg, respectively) and for those in the nifedipine group (102.7+/-5.1 versus 85.6+/-79 mmHg, respectively). During MO, LVMI of patients in the rilmenidine group (176.9+/-41.3 g/m2) was slightly higher than that of patients in the nifedipine group (172.6+/-35.1 g/m2). During M12, LVMI was observed to have decreased both for patients in the rilmenidine group (to 154.8+/-40.2 g/m2, a decrease of 22.1+/-23.3 g/m2, P< 0.001) and for those in the nifedipine group (to 145.6+/-36.4 g/m2, a decrease of 26.9+/-29.5 g/m2, P< 0.001) but the difference between these two groups was not significant (P= 0.5). CONCLUSION: One-year treatment with a daily dosage of 1 or 2 mg rilmenidine achieves a significant reduction of left ventricular mass, which is not statistically different than that occurring with a daily dosage of 40 mg of slow-release nifedipine.