Timely Recovery After Subclinical Heart Failure (TREASURE Trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- No left Ventricular Hypertrophy
研究概览
简要总结
The goal of this randomized controlled trial is to assess the effectiveness of ACE inhibitors versus standard care) in reversing asymptomatic heart failure (HF stage-B) and/or diastolic dysfunction during a two-year open-label treatment period for formerly preeclamptic women on:
- Reversibility of structural and functional myocardial impairment in asymptomatic HF towards healthy values;
- The progression from asymptomatic to symptomatic HF (symptoms scored based on the NYHA criteria);
- Cardiovascular performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires);
- Novel biomarkers and relevant microRNA's indicative for hypertrophy, fibrosis inflammation and ischemia.
Eligible subjects will be counselled and upon informed consent randomized for either medication group (n=65) or care as usual group (n=65). After a complete cardiovascular assessment, medication will be initiated open-labeled (Perindopril 2 mg or no medication). Thereafter, standard medical check-ups (blood pressure, ECG, kidney function, transthoracic cardiac ultrasound, endothelial function, quality of life questionnaires, medical history taking, blood and urine banking) will be performed every six months for two years.
Researchers will compare ACE inhibitor (Perindopril 2 mg) and care as usual (i.e. no medication) to investigate whether ACE inhibitor allows timely recovery after subclinical 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women who visit Maastricht Univeristy Medical Center+ for Cardiovascular screening with subclinical/asymptomatic heart failure (HF stage-B) and/or diastolic dysfunction;
- •Aged 18 years and older;
- •Premenopausal women with a history of preeclamptic pregnancy and premenopausal women with a history of normal pregnancy;
- •Between 0.5 and 30 years postpartum;
排除标准
- •Intention to pursue pregnancy within 2 years;
- •Already using antihypertensive medication;
- •Suffering diabetes mellitus, kidney failure (GFR<60 ml/min/1.73m2), pre-existent auto-immune disease and/or liver insufficiency;
- •Breastfeeding during participation;
- •Previous angio-edema
研究组 & 干预措施
Intervention group (Perindopril 2 mg)
Eligible subjects will be counselled and upon informed consent randomized for either medication or care as usual (i.e. no medication). After a complete cardiovascular assessment, medication will be initiated open-labeled (Perindopril 2 mg or no medication). In case of side effects Perindopril will be replaced by Valsartan 40 mg twice daily. A blood pressure below 120/80 mmHg is targeted. Blood pressure will be measured once per two weeks until the targeted blood pressure is achieved or until medication dosage has increased 4 times, corresponding Perindopril 10mg as maximum dosage or corresponding Valsartan 320mg (160 mg twice daily) as maximum dosage.
干预措施: Perindopril (Drug)
结局指标
主要结局
No left Ventricular Hypertrophy
时间窗: From enrollment to the end of treatment after 2 years
Left ventricular mass index \<95 g/m2
No impaired systolic function
时间窗: From enrollment to the end of treatment after 2 years
Left ventricular ejection fraction ≥55%
Normal diastolic function
时间窗: From enrollment to the end of treatment after 2 years
Septal e'≥8 and Lateral e'≥10 and Average e'≥9 and LA \<34 cc/m2
No concentric remodeling
时间窗: From enrollment to the end of treatment after 2 years
Relative Wall Thickness ≤0.43
次要结局
未报告次要终点
研究者
Zenab Mohseni
PI
Academisch Ziekenhuis Maastricht