NCT01961453撤回2 期
Targeting Wave Reflections to Improve Left Ventricular Hypertrophy, Fibrosis and Myocardial Function in Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in left ventricular mass
研究概览
简要总结
The purpose of this research study is to test whether treatment with isosorbide mononitrate will improve left ventricular hypertrophy ("thickening") which puts people at risk for developing heart failure. Once it develops, heart failure is a very serious condition and thus it is important to find ways to prevent it from happening. The investigators have reasons to believe that dilating the blood vessels with this specific medication will improve the thickening of the heart, which increases the risk of heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg.
- •An elevated left ventricular mass index (defined as >60 g/m1.7 in women and 80 g/m1.7 in men) OR LV posterior wall thickness >1.4 cm documented in a clinically indicated echocardiographic examination or magnetic resonance imaging scan within the previous 12 months.
- •Stable medical therapy as defined by: (1)No addition or removal of ACE inhibitors, angiotensin receptor blockers, beta-blockers, or calcium channel blockers for 30 days. (2)No change in dosage of ACE, angiotensin-receptor blocker, beta-blockers or calcium-channel blockers s of more than 100% for 30 days.
- •Current therapy with an ACE inhibitor, hydralazine or a statin, all of which have been shown to reduce nitrate tolerance.
排除标准
- •Rhythm other than sinus rhythm (i.e., atrial fibrillation).
- •Non-cardiac condition limiting life expectancy to less than one year, per physician judgment.
- •Current or anticipated future need for nitrate therapy.
- •Valve disease (> mild aortic or mitral stenosis; > moderate aortic or mitral regurgitation).
- •Hypertrophic cardiomyopathy.
- •Known infiltrative or inflammatory myocardial disease (amyloid, sarcoid).
- •Pericardial disease.
- •Primary pulmonary arteriopathy.
- •Have experienced a myocardial infarction or unstable angina, or have undergone percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) within 60 days prior to consent, or requires either PTCA or CABG at the time of consent.
- •Resting heart rate (HR) > 100 bpm.
- •A reduced LV ejection fraction (EF<50%).
- •Known severe liver disease (AST > 3x normal, alkaline phosphatase or bilirubin > 2x normal).
- •Patients with a clinically indicated stress test demonstrating significant ischemia within a year of enrollment which was not followed by percutaneous or surgical revascularization.
- •Allergy to isosorbide mononitrate.
- •Current therapy with phosphodiesterase inhibitors, such as sildenafil, vardenafil or tadalafil, since the combination of nitrates and phosphodiesterase inhibitors can result in severe hypotension.
- •Therapy with rosiglitazone, since this combination is not recommended based on epidemiologic data suggesting that it may increase the risk of myocardial ischemia.
- •Current pregnancy or a positive urine pregnancy test. Women who become pregnant during the study will be discontinued from the trial.
- •Contraindications to a cardiac MRI: (i) Central nervous system aneurysm clips; (ii) Implanted neural stimulators; (iii) Implanted cardiac pacemaker or defibrillator; (iv) Cochlear implant; (v) Ocular foreign body (e.g. metal shavings); (vi) Other implanted medical devices: (e.g. drug infusion ports); (vii) Insulin pump; (viii) Metal shrapnel or bullet; (ix) Claustrophobia; (x) Extreme obesity rendering the patient unable to fit into narrow-bore scanners; (xi) Unwillingness of the patient to undergo a cardiac MRI. All patients with metallic implants will be individually evaluated prior to MRI.
研究组 & 干预措施
Isosorbide Mononitrate, sustained release
Active Comparator
One tablet containing 60 mg (Titration Stage 1) OR 120 mg (Titration Stage 2) of sustained-release ISMN administered at 8 AM.
干预措施: Isosorbide Mononitrate, sustained release (Drug)
Placebo capsule
Placebo Comparator
One capsule of placebo administered once daily at 8 AM
干预措施: Placebo capsule (Drug)
结局指标
主要结局
Change in left ventricular mass
时间窗: 24 weeks
次要结局
- Change in extracellular volume fraction(24 weeks)
- Change in peak early diastolic intraventricular pressure gradient measured by MRI(24 weeks)
- Change in late systolic hypertension derived from pulse wave analysis(24 weeks)
- Change in peak myocardial systolic longitudinal strain measured by MRI(24 weeks)
研究者
研究点 (1)
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