Dataset Information

Rationale and design of a randomized, controlled multicentre clinical trial to evaluate the effect of bromocriptine on left ventricular function in women with peripartum cardiomyopathy.

ABSTRACT: Peripartum cardiomyopathy (PPCM) is an idiopathic heart disease that develops in the last month of pregnancy and/or the first months following delivery in previously healthy women and may lead to acute heart failure. A cleaved fragment of the nursing hormone prolactin is considered essential in the pathophysiology of PPCM. To date, no specific therapy has been tested for PPCM in a randomized controlled trial of adequate size.The purpose of this trial is to investigate the safety of the dopamin-D2-receptor agonist bromocriptine and its effects on left ventricular (LV) function in women with PPCM.This is an 11 center German trial with a prospective randomized controlled open-label design. The trial enrolls females with newly diagnosed PPCM according to European Society of Cardiology criteria with a LV ejection fraction (LVEF) <35 %. Patients are randomized 1:1 to either best supportive care (BSC) including standard heart failure therapy plus 8 weeks of bromocriptine therapy (2.5 mg b.i.d. for 14 days and 2.5 mg q.d. from day 15 to 56) or to BSC plus 1 week of low-dose bromocriptine (2.5 mg q.d.) with anticoagulant therapy at a prophylactic dose administered during the period of bromocriptine treatment in both groups. The primary endpoint is change in LVEF from baseline to 6 months follow-up as assessed by cardiac magnetic resonance imaging (or echocardiography if CMR is not tolerated). The secondary endpoints are hospitalization for worsening heart failure, heart transplantation, and all-cause mortality during follow-up or a combination of these endpoints. A total of 60 patients will be recruited (including 6 potential dropouts) giving a power of 0.9 for an expected LVEF change of 10.8 % between treatment groups at 6 months.This trial will provide important knowledge on potential benefits and safety of prolonged inhibition of prolactin release with bromocriptine in addition to standard heart failure therapy in newly diagnosed PPCM.ClinicalTrials.gov Identifier: NCT00998556.

SUBMITTER: Haghikia A

PROVIDER: S-EPMC4623094 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Rationale and design of a randomized, controlled multicentre clinical trial to evaluate the effect of bromocriptine on left ventricular function in women with peripartum cardiomyopathy.

Haghikia Arash A Podewski Edith E Berliner Dominik D Sonnenschein Kristina K Fischer Dieter D Angermann Christiane E CE Böhm Michael M Röntgen Philipp P Bauersachs Johann J Hilfiker-Kleiner Denise D

Clinical research in cardiology : official journal of the German Cardiac Society 20150531 11

<h4>Background</h4>Peripartum cardiomyopathy (PPCM) is an idiopathic heart disease that develops in the last month of pregnancy and/or the first months following delivery in previously healthy women and may lead to acute heart failure. A cleaved fragment of the nursing hormone prolactin is considered essential in the pathophysiology of PPCM. To date, no specific therapy has been tested for PPCM in a randomized controlled trial of adequate size.<h4>Aims</h4>The purpose of this trial is to investi ...[more]

PMID: 26026286

Similar Datasets

Project description:BACKGROUND:Right ventricular (RV) dysfunction predicts adverse outcome in peripartum cardiomyopathy (PPCM). We recently demonstrated beneficial effects associated with the prolactin release inhibitor bromocriptine at different doses when added to standard heart failure therapy in PPCM. Here, we evaluated for the first time the therapeutic potential of bromocriptine particularly in PPCM patients with RV involvement. METHODS:In this study, 40 patients with PPCM were included, of whom 24 patients had reduced RV ejection fraction (RVEF?<?45%). We examined the effect of short-term (1W: bromocriptine, 2.5 mg, 7 days, n?=?10) compared with long-term bromocriptine treatment (8W: 5 mg for 2 weeks followed by 2.5 mg for another 6 weeks, n?=?14) in addition to guideline-based heart failure therapy in patients with an initial RVEF?<?45% on the following outcomes: (1) change from baseline (? delta) in RVEF, (2) change from baseline in left ventricular EF (LVEF), and (3) rate of patients with full LV recovery (LVEF???50%) and (4) rate of patients with full RV recovery (RVEF???55%) at 6-month follow-up as assessed by cardiac magnetic resonance imaging. RESULTS:Reduced RVEF at initial presentation was associated with a lower rate of full cardiac recovery at 6-month follow-up (patients with RV dysfunction: 58% vs. patients with normal RV function: 81%; p?=?0.027). RVEF increased from 38?±?7 to 53?±?11% with a delta-RVEF of +?15?±?12% in the 1W group, and from 35?±?9 to 58?±?7% with a ? RVEF of +?23?±?10% in the 8W group (? RVEF 1W vs 8W: p?=?0.118). LVEF increased from 25?±?8 to 46?±?12% with a ? LVEF of +?21?±?11% in the 1W group, and from 22?±?6 to 49?±?10% with a ? LVEF of +?27?±?9% in the 8W group (? LVEF 1W vs 8W: p?=?0.211). Full LV recovery was present in 50% of the 1W group and in 64% of the 8W group (p?=?0.678). Full RV recovery was observed in 40% of the 1W group and in 79% of the 8W group (p?=?0.092). CONCLUSIONS:Despite overall worse outcome in patients with RV dysfunction at baseline, bromocriptine treatment in PPCM patients with RV involvement was associated with a high rate of full RV and LV recovery, although no significant differences were observed between the short-term and long-term bromocriptine treatment regime. These findings suggest that bromocriptine in addition to standard heart failure therapy may be also effective in PPCM patients with biventricular impairment.

Project description:Background: We sought to assess the prevalence and impact of left ventricular thrombus (LVT) in patients with peripartum cardiomyopathy (PPCM).Methods: We performed a retrospective cohort study of all admissions with PPCM as the primary diagnosis from the Nationwide Inpatient Sample database over a 11-year period. Univariate analysis of all risk factors and outcomes and multivariable logistic regression analysis of certain variables were performed and represented as odds ratio (OR) with 95% confidence interval (CI). A p value of < 0.05 was considered statistically significant. Statistical analysis was performed using epiDisplay in 'R' studio.Results: In the time frame spanning 2005 -2014, 43,986 admissions with PPCM were found which included 43,534 without LVT and 452 patients with LVT. Black race was associated with a higher incidence of LV thrombus, (p value <0.001). Comorbidities more prevalent in the LVT group were smoking, drug abuse, pregnancy induced hypertension, diabetes with complications, valvular heart disease, connective tissue disorders, coagulopathy, anemia and depression. Adverse outcomes such as congestive heart failure, arrhythmias and stroke were higher in LVT group. Conversely, Caucasian race, obesity, preeclampsia (p <0.005) were higher in those without LVT. Mean length of stay (9 vs 5 days, p <0.001), in hospital mortality (3.32% vs 1.41%, p = 0.001) and mean hospitalization charges ($85,390 vs $48,033) were higher in those with LVT. However, on multivariate logistic regression, although stroke was higher in the LVT group (adjusted OR 5.51, 95% CI, 2.2, 13.81, 5.05, p 0.002), in-hospital mortality was not significantly different between the two groups (adjusted OR 1.17, 95% CI,0.32, 4.23, p = 0.817).Conclusion: Our study showed that PPCM patients with LV thrombus had worse outcomes with respect to stroke, length of stay and in hospital mortality. Higher prevalence in patients with black race, complicated diabetes, peripheral vascular disease, valvular disease, coagulopathy, smoking, drug abuse, depression and psychoses calls for special attention to such high-risk groups for aggressive risk factor modification.

Dataset Information

Rationale and design of a randomized, controlled multicentre clinical trial to evaluate the effect of bromocriptine on left ventricular function in women with peripartum cardiomyopathy.

Publications

Rationale and design of a randomized, controlled multicentre clinical trial to evaluate the effect of bromocriptine on left ventricular function in women with peripartum cardiomyopathy.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets