Effect of Combination Therapy With Dapagliflozin Plus Low Dose Pioglitazone on Hospitalization Rate in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction
试验速览
- 阶段
- 3 期
- 入组人数
- 648
- 试验地点
- 1
- 主要终点
- Time to first hospitalization for heart failure after starting intervention
研究概览
简要总结
The prevalence of type 2 diabetes mellitus (T2DM) in Qatar and nations worldwide has increased in recent decades into epidemic proportions. Cardiovascular (CVD) disease is the leading cause of death in T2DM patients. Approximately 80% of T2DM patients will die because of CV cause. Congestive heart failure (CHF) is a major cause of CV death in T2DM, and it also is responsible for significant morbidity and health care expenditure due to high rate of hospitalization for heart failure.
详细描述
Community based studies have demonstrated similar prevalence of HF with reduced ejection fraction (HFpEF) and HF with reduced LV function (HFrEF) in patients hospitalized for CHF. Moreover, the prevalence of HFrEF is declining over the past two decades, whereas that of HFpEF is progressively increasing. Progressive increase in obesity and T2DM prevalence is likely among the principal factors responsible for the steady increase in HFpEF prevalence.
The aims of the present study are to examine whether therapies that correct the myocardial metabolic abnormalities present in subjects with T2DM and diastolic dysfunction improve myocardial diastolic dysfunction and reduce the rate of hospitalizations in patients with HFpEF
The primary objective of the study is to examine the effect of combination therapy with pioglitazone (15 mg) plus dapagliflozin (10 mg) versus placebo on hospitalization for heart failure in patients with HFpEF.
Eligible subjects, who consent for participating in the study, will be seen by the study coordinator. Medical history and physical examination will be performed. Each subject will receive the following measurements:
Medical history and physical examination including weight, height, waist, blood pressure and pulse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Random process
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes according to the ADA criteria.
- •Drug naïve or on stable dose of antidiabetic therapy (oral agents and/or insulin) for 3 months preceding recruitment.
- •Hospitalized for HFpEF (defined as hospitalization require intravenous diuresis) in the 6 months preceding recruitment.
- •eGFR >60 ml/min
- •Presence of LV diastolic dysfunction in echocardiography
- •We have limited the inclusion criteria in the present study to T2DM patients with HFpEF and evidence of diastolic dysfunction by echocardiography in order to select a homogenous group of HFpEF patients with similar etiology, likely "metabolic HFpEF". We believe that this subgroup of HFpEF will benefit most from treatment with low dose pioglitazone (15 mg) plus dapagliflozin (10 mg).
排除标准
- •Treatment with pioglitazone or SGLT2 inhibitor in the 3 months prior to recruitment.
- •eGFR < 60 ml/min
- •LVEF <50%;
- •Valvular heart disease, ASD, VSD
- •Chronic lung disease
- •diabetes mellitus type 1
- •patients with acute coronary syndrome, stroke or transient ischemic attack in the preceding 6 months
- •pregnancy or lactation period
研究组 & 干预措施
Pioglitazone Plus dapaglifliozin
Pioglitazone 15mg and dapaglifliozin 10mg together in T2DM patients having HF and HFpEF conditions
干预措施: Pioglitazone Plus dapaglifliozin (Drug)
Placebo
Beta blockers, ACEI, ARB, and aldosterone
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first hospitalization for heart failure after starting intervention
时间窗: 3 years
Hospitalization for heart failure will be defined as a hospitalization \>24 hours requiring intravenous diuretic infusion.
次要结局
- Number of all cause mortality(3 years)