NL-OMON49053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. - STADIA-HFpEF study
OLVG0 个研究点目标入组 26 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 18 years at time of screening
- •2. Symptomatic chronic heart failure patients with diagnosis of heart failure
- •NYHA class II-IV
- •Preserved systolic LV function, defined by: 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:
- •1) H2FPEF score >= 6;
- •2) HFA-PEFF score >= 5;
- •3) Paulus criteria 2007 met;
- •4) Pulmonary capillary wedge pressure > 15 mmHg at rest or > 25 mmHg with
- •exercise assessed with right heart catheterization;
- •5) ASE/EACVI 2009 recommendations for diastolic dysfunction met.
- •3. Cardiac MRI T1 derived extracellular volume <29% at screening
- •4. Oral diuretics, if prescribed to the patient according to local guidelines
- •discretion of the investigator, should be stable for at least 1 week prior to
- •baseline visit
- •5. Signed and dated written informed consent in accordance with GCP and local
- •legislation prior to admission to the trial
排除标准
- •1. Reduced systolic LV function, defined by: LVEF <50% measured at any time
- •point in the history of the patient
- •2. Obstructive coronary artery disease with evidence of ischemia
- •3. Myocardial infarction (i.e., increase in cardiac enzymes in combination with
- •symptoms of ischemia or newly developed ischemic ECG changes), coronary artery
- •bypass graft surgery or other major cardiovascular surgery, stroke or TIA in
- •past 90 days prior to screening visit
- •4. More than mild valve stenosis
- •5. More than moderate aortic and/or mitral valve regurgitation
- •6. 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
- •7. History of mitral valve plasty or replacement
- •8. Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm
- •documented by ECG at screening
- •9. Acute decompensation with necessity to treat with intravenous loop diuretics
- •10. Systolic blood pressure >=180 mmHg (confirmed with second measurement after
- •5 minutes). If SBP >150 mmHg and <180 mmHg, the patient should be receiving at
- •least 3 antihypertensive drugs at screening or baseline visit
- •11. Symptomatic hypotension and/or a SBP <100 mmHg at screening or baseline
- •12. Impaired renal function, defined as eGFR < 30 ml/min/1.73 m2
- •13. Indication of liver disease, defined by serum levels of either ALT (SGPT),
- •AST (SGOT), or alkaline phosphatase above 3x upper limit of normal as
- •determined at screening or history of cirrhosis with evidence of portal
- •hypertension such as varices
- •14. Hemoglobin <9 g/dl at screening
- •15. Chronic obstructive pulmonary disease, more than GOLD class 2
- •16. Pulmonary function test with FEV1/FVC <80%
- •17. Primary pulmonary arterial hypertension
- •18. Type 1 Diabetes Mellitus
- •19. History of ketoacidosis
- •20. Gastrointestinal surgery or GI disorder that could interfere with trial
- •medication absorption in the investigator*s opinion
- •21. 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)
- •22. Presence of any disease other than heart failure that imposes a life
- •expectancy of less than 1 year
- •23. 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
- •24. Currently enrolled in another investigational device or drug trial
- •25. Pregnancy or lactation
- •26. Chronic alcohol or drug abuse or any condition that, in the investigator*s
- •opinion, makes them unreliable trial patients or unlikely to complete the trial
- •27. Known allergy or hypersensitivity to dapagliflozin or other SGLT-2
- •28. Any other clinical condition that would jeopardize patients safety while
- 另有 2 项未显示
研究者
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