ALDOSTERONE RECEPTOR BLOCKADE IN DIASTOLIC HEART FAILUREA 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 - Aldo-DHF

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

· Current heart failure symptoms consistent with NYHA II or beyond
· Left ventricular ejection fraction (LVEF) = 50% at rest
· Sinus rhythm or artrial fibrillation
· Echocardiographic parameters of diastolic dysfunction (Grade = I, see Appendix)
· Peak VO2 = 25 ml/kg/min
· Males and females of age = 50 years
· Written informed consent of the patient

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded for ANY ONE of the following reasons:
· definite or probable pulmonary disease (VC<80% or FEV1<80% of reference values on spirometry)
· severe obesity (BMI = 36 kg/m2)
· psychological disorders with suspected interaction to study outcome
· Prior documented intolerance to an aldosterone receptor antagonist
· Prior documented systolic heart failure (LVEF = 40%)
· Changes in concomitant medication within the last two weeks prior screening visit
· Significant coronary artery disease (current angina pectoris or ischemia on stress tests; untreated coronary stenosis >50%; Myocardial infarction or CABAG within the last 3 months)
· Known contraindications for spironolactone
· Significant laboratory abnormalities (potassium = 5.1 mmol/L; hemoglobin = 11g/dL, hematocrit = 33%)
· Significant renal dysfunction (creatinine > 1.8 mg/dL or eGFR < 30 mL/min/1,73m²)
· Concomitant therapy with a potassium-sparing diuretic (e.g., triamterene, amiloride), potassium substitution, or high-dose acetylsalicylic acid (>500 mg/d) or permanent intake of non-steroidal antiphlogistic agents
· Insulin-dependent diabetes mellitus with a history of ketoacidosis
· Significant hypotension (blood pressure < 90 mmHg systolic and/or 50 mmHg diastolic)
· Pregnant or nursing women
· Women with child bearing potency without effective contraception (i.e. implants, injectables, combined oral contraceptives, some IUDs or vasectomised partner)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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