Diastolic Heart Failure MedDRA version: 8.1 Level: LLT Classification code 10008908 Term: Chronic heart failure
Conditions
Sponsors
Georg-August-Universität Göttingen
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Patients will be excluded for ANY ONE of the following reasons: · definite or probable pulmonary disease (VC50%; 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine in subjects with diastolic heart failure whether spironolactone is superior to placebo in improving maximal exercise capacity and diastolic function.;Secondary Objective: Secondary objectives of this study are to determine in subjects with diastolic heart failure whether spironolactone is superior to placebo in improving several other measures of exercise capacity and diastolic function, as well as quality of life, neuroendocrine activation, morbidity and mortality. The study will also investigate clinical safety aspects.;Primary end point(s): 1. Change in maximum exercise capacity (peak VO2 on spiroergometry) at 12 months compared to baseline 2. Change in E/E´ (relation peak early transmitral ventricular filling velocity/ early diastolic tissue Doppler velocity) as indicator of LVEDP at 12 months | — |
Countries
Austria, Germany
Outcome results
None listed