ObjectiveWe tested the hypothesis that direct intramyocardial injection of bone marrow
mononuclear cells in patients with non-ischemic dilated cardiomyopathy can improve
left ventricular function and physical capacity.MethodsThirty non-ischemic dilated cardiomyopathy patients with left ventricular ejection
fraction <35% were randomized at a 1:2 ratio into two groups, control and
treated. The bone marrow mononuclear cells group received 1.06±108 bone marrow
mononuclear cells through mini-thoracotomy. There was no intervention in the
control group. Assessment was carried out through clinical evaluations as well as
a 6-min walk test, nuclear magnectic resonance imaging and echocardiogram.ResultsThe bone marrow mononuclear cells group showed a trend toward left ventricular
ejection fraction improvement, with magnectic resonance imaging - at 3 months,
showing an increase from 27.80±6.86% to 30.13±9.06% (P=0.08) and
returning to baseline at 9 months (28.78%, P=0.77). Magnectic
resonance imaging showed no changes in left ventricular ejection fraction during
follow-up of the control group (28.00±4.32%, 27.42±7.41%, and 29.57±4.50%).
Echocardiogram showed left ventricular ejection fraction improved in the bone
marrow mononuclear cells group at 3 months, 25.09±3.98 to 30.94±9.16
(P=0.01), and one year, 30.07±7.25%
(P=0.001). The control group showed no change (26.1±4.4 vs
26.5±4.7 and 30.2±7.39%, P=0.25 and 0.10, respectively). Bone
marrow mononuclear cells group showed improvement in New York Heart Association
functional class, from 3.40±0.50 to 2.41±0.79 (P=0.002); patients
in the control group showed no change (3.37±0.51 to 2.71±0.95;
P=0.17). Six-minute walk test improved in the bone marrow
mononuclear cells group (348.00±93.51m at baseline to 370.41±91.56m at 12 months,
P=0.66) and there was a non-significant decline in the control
group (361.25±90.78m to 330.00±123.42m after 12 months, P=0.66).
Group comparisons were non-significant.ConclusionThe trend of intragroup functional and subjective improvement was not confirmed
when compared to the control group. Direct intramyocardial application of bone
marrow mononuclear cells in non-ischemic dilated cardiomyopathy was not associated
with significant changes in left ventricular function. Differences observed within
the bone marrow mononuclear cells group could be due to placebo effect or low
statistical power.
Note: This guideline is for information purposes and should not replace the clinical judgment of a physician, who must ultimately determine the appropriate treatment for each patient.
BackgroundPrehypertension is associated with higher cardiovascular risk, target organ damage, and incidence of hypertension. The Prevention of Hypertension in Patients with PreHypertension (PREVER‐Prevention) trial aimed to evaluate the efficacy and safety of a low‐dose diuretic for the prevention of hypertension and end‐organ damage.Methods and ResultsThis randomized, parallel, double‐blind, placebo‐controlled trial was conducted in 21 Brazilian academic medical centers. Participants with prehypertension who were aged 30 to 70 years and who did not reach optimal blood pressure after 3 months of lifestyle intervention were randomized to a chlorthalidone/amiloride combination pill or placebo and were evaluated every 3 months during 18 months of treatment. The primary outcome was incidence of hypertension. Development or worsening of microalbuminuria, new‐onset diabetes mellitus, and reduction of left ventricular mass were secondary outcomes. Participant characteristics were evenly distributed by trial arms. The incidence of hypertension was significantly lower in 372 study participants allocated to diuretics compared with 358 allocated to placebo (hazard ratio 0.56, 95% CI 0.38–0.82), resulting in a cumulative incidence of 11.7% in the diuretic arm versus 19.5% in the placebo arm (P=0.004). Adverse events; levels of blood glucose, glycosylated hemoglobin, creatinine, and microalbuminuria; and incidence of diabetes mellitus were no different between the 2 arms. Left ventricular mass assessed through Sokolow‐Lyon voltage and voltage‐duration product decreased to a greater extent in participants allocated to diuretic therapy compared with placebo (P=0.02).ConclusionsA combination of low‐dose chlorthalidone and amiloride effectively reduces the risk of incident hypertension and beneficially affects left ventricular mass in patients with prehypertension.Clinical Trial Registration
URL: http://www.ClinicalTrials.gov, www.ensaiosclinicos.gov. Unique identifiers: NCT00970931, RBR‐74rr6s.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.