Gender Specific Effectiveness Of SGLT2 Inhibitors In Heart Failure With Reduced Ejection Fraction- A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- To compare changes in patient-reported outcomes using Kansas City Cardiomyopathy
研究概览
简要总结
Heart failure with reduced ejection fraction (HFrEF) is a major global health concern, and its prevalence in India is high. SGLT-2 inhibitors, originally for type 2 diabetes, have become a cornerstone of guideline-directed medical therapy (GDMT) for HFrEF. While large-scale clinical trials (e.g., DAPA-HF, EMPEROR-Reduced) have demonstrated the significant benefits of SGLT2i in reducing heart failure hospitalizations and cardiovascular mortality, some meta-analyses suggest these benefits might be less pronounced in women. This potential disparity could be due to the underrepresentation of women in clinical trials, coupled with biological and lifestyle differences. This study aims to address this research gap by evaluating the real-world effectiveness of SGLT2i in HFrEF patients, with a specific focus on gender based differences. Patients started on SGLT-2 inhibitors as per eligibility criteria will be enrolled from Cardiology OPD of PGIMER, Chandigarh. At baseline and at 3- and 6-month follow-ups, a range of parameters will be assessed, which includes KCCQ-12 questionnaire (primary outcome), clinical and functional measures like the 6-minute walk test and NYHA class, and key biomarkers such as NT-proBNP and beta-hydroxybutyrate. The study will also track the incidence of HF hospitalizations and 3-point MACE, as well as the occurrence of adverse events. By collecting this comprehensive data, the research seeks to determine if a significant gender-based difference exists in the clinical benefits, quality of life improvements, and safety profile of SGLT2 inhibitors in routine clinical practice. This study could significantly influence heart failure guidelines by providing evidence for gender-specific treatment considerations with SGLT2 inhibitors. Findings may highlight disparities in patient-reported outcomes between men and women, prompting tailored patient counselling and a more personalized approach to care. Ultimately, the results will inform future research and clinical trial designs, ensuring equitable representation and a better understanding of these therapies for all patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosis of HFrEF as per ACC/ AHA 2022 with NYHA class II-III heart failure symptoms.
- •HFrEF patients newly initiated on SGLT-2 inhibitor.
- •Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines with both drugs and devices, as appropriate.
- •Patient willing to provide written informed consent to participate in the study.
排除标准
- •Any kind of severe comorbities, which delimits the patient from giving consent and participation in the study.
- •Any previous history of allergy with SGLT2 inhibitor.
- •Type 1 diabetes mellitus (T1DM).
- •Symptomatic hypotension or systolic BP less than 95 mmHg on 2 consecutive measurements.
- •Severe (eGFR less than 30mL/min/1.73 m2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of screening.
- •Pregnant, Lactating mother and women of child-bearing potential (who are not willing to use a medically accepted method of contraception).
结局指标
主要结局
To compare changes in patient-reported outcomes using Kansas City Cardiomyopathy
时间窗: 0,3,6 month
Questionnaire (KCCQ) between genders.
时间窗: 0,3,6 month
次要结局
- 1. To assess the efficacy SGLT2 inhibitors in reducing HF-related hospitalizations and 3 point(MACE (Cardiovascular death, Non-fatal MI, and Non-fatal stroke) between male and)
研究者
Dr. Aarthikaa R
PGIMER