NCT04475042Unknown2 期
Stratified Treatment to Ameliorate Diastolic Left Ventricular Stiffness in Heart Failure With Preserved Ejection Fraction. A 35-week, Single-center, Prospective, Double-blind, Controlled, Randomized, 2x2 Crossover, Interventional Phase II Study, Investigating the Effect of Treatment With Dapagliflozin 10mg od on Left Ventricular Distensibility in Patients With Early HFpEF.
Mariëlle Scheffer1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Left Ventricular (LV) e'
研究概览
简要总结
A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in patients with early HFpEF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at time of screening
- •Symptomatic chronic heart failure patients with diagnosis of heart failure and:
- •NYHA class II-IV
- •Preserved systolic Left Ventricular (LV) function, defined by: LV Ejection Fraction (LVEF) ≥ 50% and LV end-diastolic volume index <97 ml/m2
- •Evidence of diastolic LV dysfunction and at least 1 out of the 5 following additional criteria:
- •H2FPEF score ≥ 6;
- •HFA-PEFF score ≥ 5;
- •Pulmonary capillary wedge pressure > 15 mmHg at rest or > 25 mmHg with exercise assessed with right heart catheterization;
- •Cardiac MRI T1 derived extracellular volume <29% at screening
- •Oral diuretics, if prescribed to the patient according to local guidelines and at the discretion of the investigator, should be stable for at least 1 week prior to baseline visit
- •Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial
排除标准
- •Reduced systolic LV function (LVEF < 50%), measured at any time point in the history of the patient
- •Obstructive coronary artery disease with evidence of ischemia
- •Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 90 days prior to screening visit
- •More than mild valve stenosis
- •More than moderate aortic and/or mitral valve regurgitation
- •Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. hemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (stress cardiomyopathy), hypertrophic (obstructive) cardiomyopathy or known pericardial constriction
- •History of mitral valve repair or replacement
- •Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm at screening
- •Acute decompensation that requires intravenous loop diuretics
- •Systolic blood pressure ≥ 180 mmHg. If SBP > 150 mmHg and < 180 mmHg, the patient should be receiving at least 3 antihypertensive drugs at screening or baseline visit
- •Symptomatic hypotension and/or a SBP < 100 mmHg at screening or baseline visit
- •Impaired renal function, defined as eGFR < 30 ml/min/1.73 m2
- •Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3x upper limit of normal or history of cirrhosis with evidence of portal hypertension
- •Hemoglobin < 9 g/dl at screening
- •Chronic obstructive pulmonary disease, more than GOLD class 2
- •Pulmonary function test with FEV1/FVC < 80%
- •Primary pulmonary arterial hypertension
- •Type 1 Diabetes Mellitus
- •History of ketoacidosis
- •Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix or low risk prostate cancer (biopsy Gleason score of ≤ 6 and clinical stage T1c or T2a)
- •Current use or prior use of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor within 3 months prior to screening visit. Discontinuation of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor for the purposes of study enrolment is not permitted
- •Pregnancy or lactation
- •Any (clinical) condition that, in the investigator's opinion, would jeopardize patients safety while participating in this trial, or may prevent the patient from adhering to the trial protocol
研究组 & 干预措施
Group B
Active Comparator
Placebo - washout period - Dapagliflozin
干预措施: Dapagliflozin (Drug)
Group A
Active Comparator
Dapagliflozin - washout period - placebo
干预措施: Dapagliflozin (Drug)
Group A
Active Comparator
Dapagliflozin - washout period - placebo
干预措施: Placebo (Drug)
Group B
Active Comparator
Placebo - washout period - Dapagliflozin
干预措施: Placebo (Drug)
结局指标
主要结局
Left Ventricular (LV) e'
时间窗: 13 weeks
echocardiographically measured
E/e'/LV end-diastolic volume index
时间窗: 13 weeks
echocardiographically measured
次要结局
- Kansas City Cardiomyopathy Questionnaire(13 weeks)
- 6-minute walk test(13 weeks)
- Left atrial volume(13 weeks)
- Diastolic parameters(13 weeks)
- Left atrial function(13 weeks)
研究者
Mariëlle Scheffer
Principal Investigator
Onze Lieve Vrouwe Gasthuis
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Stratified Treatment to Ameliorate Diastolic left ventricular stIffness in eArly Heart Failure with preserved Ejection Fraction (STADIA-HFpEF) A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in patients with early HFpEF.10019280diastolic heart failureHFpEFNL-OMON49053OLVG26
已完成
3 期
Obese Hypertension Study (0954-315)HypertensionNCT00289887Organon and Co261
已完成
不适用
ew treatment for cardiac abnormalities in cirrhosisCTRI/2018/03/012325Institute of liver and Biliary Sciences189
已完成
4 期
A Trial of Fimasartan for Early Diastolic Heart FailureHypertensionNCT01691118Asan Medical Center60
已完成
4 期
Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With HypertensionHypertensionNCT00280540Novartis648