A multicenter, randomized, controlled trial comparing the occurrence of major adverse cardiovascular events (MACEs) in patients (pts) with prostate cancer (pc) and cardiovascular disease (CVD) receiving degarelix (GnRH receptor antagonist) or leuprolide (GnRH receptor agonist).

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. TPS5101-TPS5101 ◽  
Author(s):  
Susan F. Slovin ◽  
Chiara Melloni ◽  
Samreen Mansor-Lefebvre ◽  
Anders Neijber ◽  
Matthew Roe
Keyword(s):  
Prostate Cancer ◽  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Cardiovascular Events ◽  
Receptor Agonist ◽  
Controlled Trial ◽  
Gnrh Receptor ◽  
Major Adverse Cardiovascular Events ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

A multicenter, randomized, controlled trial comparing the occurrence of major adverse cardiovascular events (MACEs) in patients (pts) with prostate cancer (pc) and cardiovascular disease (CVD) receiving degarelix (GnRH receptor antagonist) or leuprolide (GnRH receptor agonist).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS395-TPS395 ◽  
Author(s):  
Susan F. Slovin ◽  
Chiara Melloni ◽  
Samreen Mansor-Lefebvre ◽  
Anders Neijber ◽  
Matthew Roe
Keyword(s):  
Randomized Controlled Trial ◽  
Gnrh Agonist ◽  
Receptor Agonist ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Gnrh Receptor ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Multicenter Randomized Controlled Trial ◽  
The Impact

TPS395 Background: Epidemiological studies showed an association between GnRH agonists and a long-term increased risk of CVD, early after treatment initiation and with a higher risk seen in pts with pre-existing CVD. Retrospective pooled safety analyses of 6 randomized trials showed that significantly fewer pts treated with the GnRH receptor antagonists, degarelix, had a CV event or death compared with pts receiving a GnRH receptor agonist. In those studies showing an increased CV risk, Androgen-Deprivation Therapy (ADT) was primarily with GnRH receptor agonists. The mechanistic differences between GnRH antagonists and agonists, including testosterone surge and time to suppression at initiation, effect on follicle-stimulating hormone and on GnRH receptors e.g. T-lymphocytes in atherosclerotic plaque, raises the possibility of different CV risk profiles. The PRONOUNCE trial is the first to prospectively assess whether a GnRH agonist/antagonist can worsen pre-existing CVD; assess the impact of GnRH agonist/antagonist on CV risk biomarkers; and effects of hormonal therapy on immune system. Methods: PRONOUNCE is a multi-center, randomized, controlled trial of 900 men with pc and concomitant CVD, assessing adjudicated MACEs, i.e. myocardial infarction (fatal, non-fatal), stroke (fatal, non-fatal), or death in pts randomized 1:1 to either degarelix or leuprolide according to label recommendations for up to one year. Eligibility include pre-defined CVD, metastatic or locally advanced pc; high-risk disease with plan for definitive radiation therapy (RT); recurrence after local therapy with PSA doubling time <12 months; or salvage RT with neoadjuvant/adjuvant ADT for at least 12 months. Serum samples are collected for the analysis of various CV, inflammatory, and immune biomarkers. The primary endpoint will be based on Kaplan-Meier estimator of survival function and stratified for age group and region. Interim analysis is scheduled when 50% of MACE events have occurred allowing the DSMB to recommend for sample size correction. Clinical trial information: NCT02663908.

scholarly journals Postnatal Enalapril to Improve Cardiovascular Function Following Preterm Preeclampsia (PICk-UP):

Hypertension ◽  
2020 ◽  
Vol 76 (6) ◽  
pp. 1828-1837 ◽  
Author(s):  
Laura Ormesher ◽  
Suzanne Higson ◽  
Matthew Luckie ◽  
Stephen A Roberts ◽  
Heather Glossop ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Global Longitudinal Strain ◽  
Cardiovascular Function ◽  
Left Ventricular ◽  
Targeted Interventions ◽  
Risk Of Death ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Hypertensive disease in pregnancy is associated with future cardiovascular disease and, therefore, provides an opportunity to identify women who could benefit from targeted interventions aimed at reducing cardiovascular morbidity. This study focused on the highest-risk group, women with preterm preeclampsia, who have an 8-fold risk of death from future cardiovascular disease. We performed a single-center feasibility randomized controlled trial of 6 months’ treatment with enalapril to improve postnatal cardiovascular function. Echocardiography and hemodynamic measurements were performed at baseline (<3 days), 6 weeks, and 6 months postdelivery on 60 women. At randomization, 88% of women had diastolic dysfunction, and 68% had concentric remodeling/hypertrophy. No difference was seen in total vascular resistance ( P =0.59) or systolic function (global longitudinal strain: P =0.14) between groups at 6 months. However, women treated with enalapril had echocardiographic measurements consistent with improved diastolic function (E/E′[the ratio of early mitral inflow velocity and early mitral annular diastolic velocity]: P =0.04) and left ventricular remodeling (relative wall thickness: P =0.01; left ventricular mass index: P =0.03) at 6 months, compared with placebo. Urinary enalapril was detectable in 85% and 63% of women in the enalapril arm at 6 weeks and 6 months, respectively. All women responded positively to taking enalapril in the future. Our study confirmed acceptability and feasibility of the study protocol with a recruitment to completion rate of 2.2 women per month. Importantly, postnatal enalapril treatment was associated with improved echocardiographic measurements; these early improvements have the potential to reduce long-term cardiovascular disease risk. A definitive, multicenter randomized controlled trial is now required to confirm these findings. Registration— URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03466333.

scholarly journals A digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial

2020 ◽  
Vol 3 (1) ◽  
Author(s):  
Julie Redfern ◽  
Genevieve Coorey ◽  
John Mulley ◽  
Anish Scaria ◽  
Lis Neubeck ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Primary Care ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Risk Factor ◽  
Digital Health ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Abstract Digital health applications (apps) have the potential to improve health behaviors and outcomes. We aimed to examine the effectiveness of a consumer web-based app linked to primary care electronic health records (EHRs). CONNECT was a multicenter randomized controlled trial involving patients with or at risk of cardiovascular disease (CVD) recruited from primary care (Clinical Trial registration ACTRN12613000715774). Intervention participants received an interactive app which was pre-populated and refreshed with EHR risk factor data, diagnoses and, medications. Interactive risk calculators, motivational messages and lifestyle goal tracking were also included. Control group received usual health care. Primary outcome was adherence to guideline-recommended medications (≥80% of days covered for blood pressure (BP) and statin medications). Secondary outcomes included attainment of risk factor targets and eHealth literacy. In total, 934 patients were recruited; mean age 67.6 (±8.1) years. At 12 months, the proportion with >80% days covered with recommended medicines was low overall and there was no difference between the groups (32.8% vs. 29.9%; relative risk [RR] 1.07 [95% CI, 0.88–1.20] p = 0.49). There was borderline improvement in the proportion meeting BP and LDL targets in intervention vs. control (17.1% vs. 12.1% RR 1.40 [95% CI, 0.97–2.03] p = 0.07). The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control, p = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control, p = 0.02). In conclusion, a consumer app integrated with primary health care EHRs was not effective in increasing medication adherence. Borderline improvements in risk factors and modest behavior changes were observed.

P3350Design of a multicenter, open-label, randomized controlled trial: effects of intensive systolic blood pressure lowering treatment in reducing risk of vascular events (ESPRIT)

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Liu ◽  
J Li ◽  
X H Huang
Keyword(s):  
Myocardial Infarction ◽  
Blood Pressure ◽  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Elevated Blood ◽  
Open Label ◽  
Randomized Controlled ◽  
Major Cardiovascular Events

Abstract Background Patients with cardiovascular diseases (CVD) are at high risk for recurrent major cardiovascular events. Effective public health strategies to lower blood pressure (BP) are necessary to reduce risk of cardiovascular disease. However, substantial uncertainty remains about the optimal target level to lower BP in patients with cardiovascular disease. Purpose To assess the effects on the incidence of major cardiovascular events in patients with CVD during the scheduled treatment period of greater reduction in blood pressure with a systolic BP (SBP) target <120 mmHg versus <140 mmHg. Methods This study is a multicenter, open-label, randomized controlled trial comparing two strategies for lowering SBP: lowering SBP to the standard target of <140 mmHg; and lowering BP to a more intensive target of <120 mmHg. This study will enroll 12,000 Chinese participants from 100–200 hospitals, follow-up for about 3 years. We will include participants aged ≥50 years old with SBP ≥130 mmHg, having a history of vascular disease (including myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, carotid endarterectomy or carotid stenting, peripheral artery disease with revascularization, abdominal aortic aneurysm ≥5 cm with repair) or stroke. The primary outcome is the first occurrence of major cardiovascular events defined as a composite of myocardial infarction, stroke, coronary or non-coronary revascularization events, and cardiovascular death. Secondary outcomes include the components of the primary composite outcome, hospitalized heart failure and all cause of death and non-cardiovascular outcomes (kidney disease and cognitive outcomes). Results Regarding the results, we hypothesize that comparing with SBP target of <140 mmHg, more intensive SBP target of <120 mmHg can further reduce the occurrence of cardiovascular events in CVD patients with elevated blood pressure. Conclusion This study can provide reliable evaluation on whether more intensive SBP target of <120 mmHg is more desirable than SBP target of <140 mmHg in CVD patients with elevated blood pressure.

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