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    Summary
    EudraCT Number:2006-002605-31
    Sponsor's Protocol Code Number:Aldo-DHF
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-11-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2006-002605-31
    A.3Full title of the trial
    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
    A.3.2Name or abbreviated title of the trial where available
    Aldo-DHF
    A.4.1Sponsor's protocol code numberAldo-DHF
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGeorg-August-Universität Göttingen
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Verospiron T 25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderHormosan Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVerospiron T 25 mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNspironolactone
    D.3.9.1CAS number 52-01-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diastolic Heart Failure
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Aldo-FIBRO (Effect of aldosterone receptor blockade on diastolic function and fibrosis)
    Aldo-FIBRO will assess the effects of spironolactone on invasive parameters of diastolic function and on myocardial fibrosis. A detailed investigational plan, including patient informed consent forms, will be provided by the coordinating investigator. The study will be performed at the centres Berlin Campus Benjamin-Franklin and Göttingen.

    2. Aldo-SYST (Effects of aldosterone receptor blockade on systolic function in patients with diastolic heart failure)
    Aldo-SYST will test the effects of spironolactone on subtle alterations of systolic function in patients with diastolic heart failure. Subtle alterations in systolic heart failure will be assessed by modern echocardiographic parameters (e.g., strain, strain rate). The study will be performed at centres willing to participate and able to perform these analyses. Data will be obtained during echocardiographic procedures scheduled in Aldo-DHF.

    3. Aldo-INFLAM (Effects of aldosterone receptor blockade on inflammatory markers in patients with diastolic heart failure)
    Aldo-INFLAM will assess markers of inflammation (TNF, IL-6, sTNFR-1) and their influence on primary endpoints of the study. Those markers are highly predictive of adverse outcomes in patients with systolic heart failure, but have so far not been assessed in diastolic dysfunction. This study is open for all centres willing to participate. Data will be obtained from blood samples scheduled in Aldo-DHF; no additional sampling will be necessary.

    4. Aldo-ECG (Effects of aldosterone receptor blockade on myocardial repolarisation, conduction and heart rate variability in patients with diastolic heart failure)
    Aldo-ECG will test the effects of spironolactone on markers for altered myocardial repolarisation, conduction and heart rate variability. Altered myocardial repolarisation and conduction have prognostic value by increasing the incidence of sudden cardiac death. Reduced heart rate variability is associated with increased morbidity and mortality in patients with chronic heart failure. The study will be performed at centres willing to participate. Data will be obtained with 12-lead Holter ECG which will be provided from Charité Berlin. Analyses will be done blinded at Charité.

    5. Aldo-CYP (Effects of aldosterone receptor blockade on aldosterone synthesis and influence of CYP11B2-polymorphism in patients with diastolic heart failure)
    Aldo-CYP will investigate the effects of spironolactone on plasma levels of aldosterone and factors of aldosterone synthesis, e.g. expression of aldosterone synthase (CYP11B2). Also the relevance of CYP11B2- polymorphism in patients with symptomatic diastolic heart failure will be assessed. Furthermore the impact of aldosterone baseline levels on treatment effects will be investigated. The study will be performed at centres willing to participate. Analyses will be done blinded at the reference lab in Göttingen.
    E.3Principal 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
    E.4Principal 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)
    E.5 End points
    E.5.1Primary 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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Patients will be followed on study medication for 12 months. Additionally, patients recruited in the first 6 months will be followed up to 18 months.

    In case of the following situations, a premature termination of the trial has to be considered:
    - Serious adverse drug reactions / not justifiable toxicity
    - Substantial changes in risk-benefit considerations
    - New insights from other trials
    - Insufficient efficacy
    - Insufficient recruitment rate
    - Unsustainable trial organisation
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-11-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state420
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After completion of the individual last follow up visit including documentation, study medication (blinded or unblinded) should be stopped in every patient. An additional post follow up visit (i.e. 1 week after stopping of trail medication) should be performed to avoid withdrawal related adverse events and is up to the local investigators opinion. Concomitant medication should be continued as usual.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-22
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