2024-515044-23-01招募中2 期
Dapagliflozin in patients with Right Heart Failure (Dapa-RHF)
Universitaetsmedizin Goettingen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月30日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in serum NT-proBNP level from baseline to end of treatment (Delta-NTproBNP)
研究概览
简要总结
To demonstrate that dapagliflozin on top of standard of care is superior in reducing the primary outcome in patients with chronic right heart failure compared to standard of care plus placebo.
研究设计
- 研究类型
- Interventional
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
- •The Patient is willing and able to participate and provide written informed consent
- •Age ≥ 18 years and < 90 years
- •Presence of RHF defined as (criteria a-c must all be fulfilled): a) Reduced right ventricular systolic function or RV strain defined as at least one of the following tricuspid annular plane systolic excursion (TAPSE) <16 mm RV fractional area change (FAC) <35% Systolic pulmonary artery pressure (PAP sys) ≥35 mmHg combined with an extended inferior vena cava (>2,1 cm) with reduced collapsibility (<50%) during sniff inspiration assessed in echocardiography b) N-terminal pro-BNP (NT-proBNP) >125 pg/ml c) Clinical signs of right cardiac congestion (edema, and / or extended inferior vena cava (>2,1 cm) with reduced collapsibility (<50%) during sniff inspiration assessed in echocardiography and / or pleural effusion on sonography and / or chest radiograph) or need for diuretic therapy to prevent signs of congestion
- •For women of childbearing potential* (until 1 year after menopause): a) Negative pregnancy test AND b) Use of highly effective methods of contraception during treatment plus 5 days after the end of study drug administration
排除标准
- •Heart failure with reduced left ventricular (LV) ejection fraction (LVEF <40%)
- •Known contraindication for the treatment with dapagfliflozin
- •Type 1 diabetes mellitus
- •Incapacity to understand the nature, significance and implications of the clinical trial and / or to provide written informed consent
- •Known active alcohol and / or drug abuse
- •Current participation in another interventional trial
- •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or personnel at the study site)
- •Pregnancy or lactating women
- •Body mass index >50 kg/m2
- •Known acute or chronic liver disease with clinical signs of severe impairment of liver function (e.g., ascites, oesophageal varices, coagulopathy)
- •Hepatic impairment defined as aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment)
- •Pulmonary arterial hypertension (PAH, PH Group I)
- •Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after randomization
- •Active symptomatic infection (e. g. with body temperature ≥38°C) requiring anti-infective treatment (based on investigator's clinical judgement)
- •Acute (within 30 days) pulmonary embolism
- •Acute (within 30 days) right ventricular myocardial infarction
- •Current medication with any SGLT2 inhibitor
- •Chronic kidney disease (CKD) or acute kidney injury with eGFR < 25 ml/min/1,73 m², or end-stage renal failure with the need for chronic dialysis treatment
- •Systolic blood pressure (SBP) <90 mmHg at screening visit confirmed on 2 consecutive measurements
- •Any contraindication for cardiac magnetic resonance imaging (MRI)
- •Known intolerance or hypersensitivity to dapagliflozin
结局指标
主要结局
Change in serum NT-proBNP level from baseline to end of treatment (Delta-NTproBNP)
Change in serum NT-proBNP level from baseline to end of treatment (Delta-NTproBNP)
次要结局
- Change in quality of life assessed by overall summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) (a specific HF patient reported outcome questionnaire) from baseline to end of treatment
- Change in RV ejection fraction (RV EF) [%] assessed in cardiac MRI from baseline to end of treatment
- Change in exercise capacity assessed by the 6 min walking distance [meters] from baseline to end of treatment
- Change in NYHA (New York Heart Association) class from baseline to end of treatment
研究者
Annika Wille
Scientific
Universitaetsmedizin Goettingen
研究点 (1)
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