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| [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN94726526 |
| DOI | 10.1186/ISRCTN94726526 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | 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 |
| Scientific title | |
| Acronym | Aldo-DHF |
| Serial number at source | N/A |
| Study hypothesis | 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 heart function. 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. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Local ethics committee in Göttingen and the BfAM. |
| Study design | Multicenter, prospective, randomised, double-blinded, placebo-controlled, parallel group, phase IIb trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Diastolic heart failure |
| Participants - inclusion criteria |
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 |
| Participants - exclusion criteria |
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 |
| Anticipated start date | 01/11/2006 |
| Anticipated end date | 31/10/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 420 |
| Interventions | Once randomised, all patients will take study medication (25 mg spironolactone or placebo) once daily in the morning for 12 months. Patients recruited in the first six months will be followed up to 18 months. Spironolactone will be applied in one fixed dose, i.e., 25 mg, but may be down titrated if indicated. |
| Primary outcome measure(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 Left Ventricular End Diastolic Pressure (LVEDP) at 12 months |
| Secondary outcome measure(s) |
1. Change in primary endpoints at 18 months
2. Change in the echocardiographic Grade of diastolic dysfunction 3. Change in neuroendocrine activation (natriuretic peptides) 4. Change in six minutes walking distance 5. Change in quality of life (Minnesota living with heart failure questionnaire; Short Form Health Survey [SF-36]) 6. Combined and separately morbidity and mortality (all-cause; cardiovascular) |
| Sources of funding | Federal Ministry for Education and Research (BMBF), Health Research (Germany) |
| Trial website | |
| Publications |
1. 2010 prototcol in http://www.ncbi.nlm.nih.gov/pubmed/20538867
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23443441 |
| Contact name | Prof Burkert Pieske |
| Address |
Department of Cardiology and Pneumology
Georg-August-Universität Göttingen Robert-Koch-Str. 40 |
| City/town | Göttingen |
| Zip/Postcode | 37075 |
| Country | Germany |
| Tel | +49 (0)551-398925 |
| Fax | +49 (0)551-3919127 |
| Sponsor | Georg-August University of Göttingen (Georg-August-Universität Göttingen) (Germany) |
| Address |
c/o Prof. Dr. Burkert Pieske
Robert-Koch-Str. 40 |
| City/town | Göttingen |
| Zip/Postcode | 37075 |
| Country | Germany |
| Tel | +49 (0)551 398925 |
| Fax | +49 (0)551-3919127 |
| pieske@med.uni-goettingen.de | |
| Sponsor website: | http://www.uni-goettingen.de/ |
| Date applied | 10/10/2006 |
| Last edited | 28/02/2013 |
| Date ISRCTN assigned | 07/11/2006 |
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| © 2013 ISRCTN unless otherwise stated. | |
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