Effects of Testosterone on Myocardial Repolarization in Patients With Hypogonadism With/Without Chronic Heat Failure (NYHA Class I-II)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 主要终点
- QT duration reduction
研究概览
简要总结
The main of the study is to evaluate the effect of testosterone on ventricular repolarization in patients with mild heart failure, at risk for sudden cardiac death. The electrocardiographic markers studied are QT variability index, the short term variability index.
详细描述
Background:
It has been widely demonstrated in experimental cardiology that estrogen may play a protective role on cardiovascular system, reducing myocardial damage in ischemia-reperfusion injury. Poor are the contributions of the effects of estrogen in the presence of testosterone which also showed potentially cardioprotective effects. Recently it has emerged strong evidence showing that the increase in the repolarization phase of myocardial duration and its temporal dispersion are predictive markers of cardiac death in post-ischemic dilated cardiomyopathy. In addition, the temporal dispersion of the final part of the repolarization phase (Tpeak-Tend) is specifically predictive for sudden cardiac death. In fact, the investigators propose the following plan of experimental study. It will be measured by the duration of the repolarization phase and its basal temporal dispersion and the peak of the heart rate obtained during stress test, in male subjects before and during testosterone replacement therapy.
Patients evaluation baseline, after 1 month and after 6 months of follow up:
Endocrinological evaluation with measurement of body weight, height, BMI calculation and (digital rectal examination) DRE, blood sample.
Laboratory:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 70 aa with blood testosterone values <11.4 nmol / L;
- •Sinus rhythm at 12-lead ECG;
- •Hypogonadism: Total Testosterone <3.5 ng / ml or Free testosterone <250 pmol / L (10 pg / mL) detected (8: 00-11: 00 am) in two successive measurements taken baseline and confirmed at 7 days apart, reduced libido and / or at least two symptoms of hypogonadism evaluated AMS questionnaire
- •previous myocardial infarction and relief echocardiographic fraction of left ventricular ejection greater than or equal to 40% (in chronic heart failure patients);
- •stable clinical and hemodynamic conditions for more than three months;
- •No therapeutic changes in the last 3 months;
- •signing the informed consent.
排除标准
- •therapy with testosterone undertaken within 6 months of enrollment or other therapy with steroids undertaken within 3 months thereafter
- •Clinical history of prostate cancer
- •elevated PSA values (adjusted for age)
- •digital rectal exploration (DRE) suggestive of prostate cancer
- •Symptoms of benign prostatic hypertrophy (BPH) with severe obstructive symptoms
- •Hematocrit> 52% at baseline
- •History of clinically significant hepatic, hematological, renal pathology
- •Clinical history of breast cancer
- •Hyperprolactinemia or other endocrine diseases (empty sella syndrome and pituitary expansive diseases measured by MRI)
- •Age less than 40 or older than 70 years;
- •Severe left ventricular systolic dysfunction (left ventricular ejection fraction <40%) and / or echocardiographic evidence of severe valvular disease;
- •chronic atrial fibrillation or frequent extrasystoles (> 1 extrasystole / min);
- •Presence of complete branch block;
- •Unstable clinical and hemodynamic conditions and / or changes in therapy over the last three months;
- •Presence of prostatic hyperplasia decisive severe obstruction to uroflow study;
- •neoplasms diagnosed and treated less than five years later;
- •Any other condition that medical judgment precludes patient safety
研究组 & 干预措施
Hypogonadic with chronic heart failure
patients suffering from mild to moderate heart failure (LVEF ≥ 40%, NYHA I-II), and hypogonadism (plasma testosterone levels <11.4 nmol / L);
干预措施: Testosterone Undecanoate (Drug)
Hypogonadic
patients just with hypogonadism (testosterone <11.4 nmol / L) in the absence of documented cardiovascular disease
干预措施: Testosterone Undecanoate (Drug)
结局指标
主要结局
QT duration reduction
时间窗: baseline (before testosterone administration), after 1 month and after 6 months of follow up
Reduction of the absolute QT interval value and its space and time dispersion
次要结局
- hypogonadism treatment(baseline (before testosterone administration), after 1 month and after 6 months of follow up)
研究者
Gianfranco Piccirillo
Director Syncope Unit I Clinica Medica, Policlinico Umberto I, Rome, Italy, Clinical Professor
University of Roma La Sapienza