Prospective evaluation of eGFR changes during therapy optimization in heart failure patients with chronic kidney disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Mean change in eGFR levels from baseline to 16 weeks.
研究概览
简要总结
Background
Heart failure is a chronic disease where heart’s ability to pump the blood adequately to
periphery is reduced which usually results in symptoms like breathlessness, swelling in the
legs, ankles, and feet, fatigue and weakness, rapid or irregular heartbeat, light-headedness etc.
CKD is common in patients with HF and is associated with high morbidity and mortality. This study compares the effectiveness and safety
analysis of first line drug therapies used in HErEF and CKD patients.
Materials and Methods
The study is designed as single centre, Prospective observational study. Participants meeting
the eligibility criteria will be recruited from the Cardiology OPD of AIIMS Jodhpur. The study will involve recording of eGFR, NT-pro-BNP, GDF-15, KCCQ
OS, ECHO findings in these patients. Subsequently, the safety and effectiveness of all first line
drugs used in HErEF and CKD will be evaluated. The outcomes of the study will be determined
based on the assessment at the 16th week.
Implications
According to the guidelines set forth by AHA, the initial pharmacological approach for
managing HFrEF includes the utilization of beta blockers, Angiotensin converting enzyme (ACE) inhibitors, Angiotensin
receptor blockers (ARBs), Angiotensin receptor neprilysin inhibitors (ARNIs), Mineralocorticoid receptor antagonists (MRA), and SGLT2 inhibitors. However there are
challenges to the implementation of these medications in patients with concomitant CKD due
to increased vulnerability to common side effects (worsening renal function, hyperkalaemia,
hypotension). Therefore this study is planned for understanding the relative safer regime among the first line therapies for HErEF in
patients with concomitant CKD.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of age 18 year to 80 year and of either sex.
- •Patients of Heart failure with reduced ejection fraction.
- •Patients with eGFR less than 90 ml per min per 1.73 m2 at screening.
排除标准
- •Patients who are already on any of the first-line heart failure drugs for other indications.
- •Patients with preserved ejection fraction.
- •Patients with raised AST/ALT more than 3 times from baseline.
- •Pregnant and lactating women.
结局指标
主要结局
Mean change in eGFR levels from baseline to 16 weeks.
时间窗: baseline, 16 weeks.
次要结局
- 1. Mean change in eGFR levels from baseline to 16 weeks based on type of(therapeutic intervention.)
研究者
Dr Shoban Babu Varthya
All India Institute Of Medical Sciences, Jodhpur