ISRCTN94726526已完成2 期
Aldosterone receptor blockade in Diastolic Heart Failure: a double-blind, randomised, placebo-controlled, parallel group study to determine the effects of spironolactone on exercise capacity and diastolic function in patients with symptomatic diastolic heart failure
Georg-August University of Göttingen (Georg-August-Universität Göttingen) (Germany)0 个研究点目标入组 422 人开始时间: 2006年11月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 422
研究概览
简要总结
2010 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/20538867 prototcol 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23443441 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24182675 results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34685778/ (added 15/12/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34480783/ Post hoc analysis (added 22/03/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37020188/ (added 06/04/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Current heart failure symptoms consistent with New York Heart Association (NYHA) grade II or beyond
- •2. Left Ventricular Ejection Fraction (LVEF) more than or equal to 50% at rest
- •3. Sinus rhythm
- •4. Echocardiographic parameters of diastolic dysfunction (more than or equal to Grade I)
- •5. Peak Oxygen uptake (VO2) less than or equal to 20 ml/kg/min
- •6. Males and females of age 50 years or over
- •7. Written informed consent of the patient
排除标准
- •1. Definite or probable pulmonary disease (Vital Capacity [VC] less than 80% or Forced Expiratory Volume in one second [FEV1] less than 80% of reference values on spirometry)
- •2. Severe obesity (Body Mass Index [BMI] more than or equal to 36 kg/m^2)
- •3. Psychological disorders with suspected interaction to study outcome
- •4. Prior documented intolerance to an aldosterone receptor antagonist
- •5. Prior documented systolic heart failure (LVEF less than or equal to 40%)
- •6. Changes in concomitant medication within the last two weeks prior screening visit
- •7. Significant coronary artery disease (current angina pectoris or ischemia on stress tests; untreated coronary stenosis more than 50%; Myocardial infarction or Coronary Artery Bypass Graft (CAGB) within the last three months)
- •8. Known contraindications for spironolactone
- •9. Significant laboratory abnormalities (potassium more than or equal to 5.1 mmol/L; haemoglobin less than or equal to 11g/dL, hematocrit less than or equal to 33%)
- •10. Significant renal dysfunction (creatinine more than 1.8 mg/dL)
- •11. Concomitant therapy with a potassium-sparing diuretic (e.g., triamterene, amiloride), potassium substitution, or high-dose acetylsalicylic acid (more than 500 mg/d) or permanent intake of non-steroidal antiphlogistic agents, digitalis
- •12. Insulin-dependent diabetes mellitus with a history of ketoacidosis
- •13. Suspected metabolic acidosis
- •14. Significant hypotension (blood pressure less than 90 mmHg systolic and/or less than 50 mmHg diastolic)
- •15. Any patient characteristic that may interfere with compliance with the study protocol, such as dementia, substance abuse, history of non-compliance with prescribed medications or medical appointments
- •16. Pregnant or nursing women
- •17. Women with child bearing potency without effective contraception (except for implants, injectables, combined oral contraceptives, some IntraUterine Devices [IUDs] or vasectomised partner)
- •18. Concomitant participation in other clinical trials
- •19. Therapy with an aldosterone receptor antagonist within the last three months
- •20. Participation in another clinical trial within the last 30 days
研究者
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