2025-520969-51-00招募中4 期
Effects of sodium-glucose cotransporter 2 inhibition on the mechanisms of heart failure with preserved ejection fraction
Fundación para la Innovación en Biomedicina, Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月31日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Systolic properties derived from PV curve analysis: Maximum elastance
研究概览
简要总结
To identify the underlying the biological and biomechanical mechanisms responsible for the cardiovascular benefit demonstrated by iSGLT2 in patients with ICFEP.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adults of both genders ≥ 18 years
- •Diagnosis of HFpEF according to clinical criteria, with a history of hospitalization or the need for intravenous diuretic treatment in the previous 6 months, along with evidence of diastolic dysfunction based on echocardiographic criteria
- •Patients with or without Type II Diabetes Mellitus
- •Clinically stable condition (> 1 month after hospitalization for HF decompensation or since the last dose of intravenous diuretic treatment)
- •Clinical indication for cardiac catheterization
- •Clinical indication to receive de novo treatment with SGLT2 inhibitors
- •Signed informed consent
排除标准
- •Participation in another clinical trial within 30 days prior to the start of the current study
- •Pregnant or breastfeeding women
- •Prior or current treatment with SGLT2 inhibitors
- •Significant coronary artery disease
- •Aortic or mitral valvular disease ≥ moderate
- •Contraindications for dapagliflozin treatment according to the product label (hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption; moderate-to-severe renal insufficiency - CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m² -; severe hepatic insufficiency).
- •Stroke within 12 months prior to inclusion
- •Respiratory impairment or the need for home oxygen therapy
- •Life expectancy of less than 2 years due to any cause
结局指标
主要结局
Systolic properties derived from PV curve analysis: Maximum elastance
Systolic properties derived from PV curve analysis: Maximum elastance
Diastolic properties derived from PV curve analysis: Relaxation, stiffness, equilibrium volume, elastic recoil
Diastolic properties derived from PV curve analysis: Relaxation, stiffness, equilibrium volume, elastic recoil
次要结局
- Reverse geometric remodeling variables of the LV: Ventricular volumes and mass measured by cardiac magnetic resonance imaging (MRI)
- Intraventricular flow patterns based on Doppler echocardiography and phase-contrast MRI: Vorticity parameters and blood transport into the LV; energy exchange between the myocardium and blood
- Cardiomyocyte alterations: grade of hypertrophy assessed by morphometry and expression of pro-hypertrophic genes (atrial natriuretic peptide, sarcomeric proteins using real-time RT-PCR and western blot)
- Interstitial and perivascular fibrosis
- Degree of collagen crosslinking
- Microvascular alterations
- Cardiomyocyte stiffness: Titin
- Extracellular matrix: Lysyl-oxidases and hydroxylases, miR-19b, WISPER, and AGEs
- Cardiomyocytes: NT-proBNP, high-sensitivity troponin T (TnT)
研究者
Dr. Javier Bermejo
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
研究点 (1)
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