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    Summary
    EudraCT Number:2018-003662-14
    Sponsor's Protocol Code Number:GN17CA082
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-19
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2018-003662-14
    A.3Full title of the trial
    Patiromer-facilitated, dose-escalation of mineralocorticoid antagonists for the management of worsening congestion in people with heart failure and hyperkalaemia.

    A Phase IV, registry-based, randomised, controlled, open-label trial investigating the potential for patiromer-facilitated use of higher doses of mineralocorticoid antagonists in addition to standard care (compared to standard care alone) to improve congestion, well-being, morbidity and mortality.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can patiromer (a substance that binds potassium in the gut) enable use of higher doses of medicines to improve outcomes for people with worsening heart failure?
    A.3.2Name or abbreviated title of the trial where available
    RELIEHF (RELieving Increasing oEdema due to Heart Failure), v1.0
    A.4.1Sponsor's protocol code numberGN17CA082
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04142788
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNHS Greater Glasgow and Clyde
    B.1.3.4CountryUnited Kingdom
    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
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Glasgow
    B.1.3.4CountryUnited Kingdom
    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 supportVIFOR Pharma
    B.4.2CountrySwitzerland
    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 Veltassa
    D.2.1.1.2Name of the Marketing Authorisation holderVifor Fresenius Medical Care Renal Pharma France
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameVeltassa
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    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 INNPatiromer sorbitex calcium
    D.3.9.1CAS number 1415477-49-4
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive namePatiromer
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPatiromer sorbitex calcium
    D.3.9.1CAS number 1415477-49-4
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive namePatiromer
    D.3.9.4EV Substance CodeAS8
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16.8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPatiromer sorbitex calcium
    D.3.9.1CAS number 1415477-49-4
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive namePatiromer
    D.3.9.4EV Substance CodeAS9
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25.2
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Spironolactone
    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 nameSpironolactone
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 3
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Eplerenone
    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 nameEplerenone
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNEplerenone
    D.3.9.1CAS number 107724-20-9
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEplerenone
    D.3.9.1CAS number 107724-20-9
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeAS6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    People with heart failure, worsening symptoms and signs of congestion and serum potassium >5mmol/L
    E.1.1.1Medical condition in easily understood language
    People with heart failure, worsening symptoms and signs of congestion and serum potassium >5mmol/L
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10010684
    E.1.2Term Congestive heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    A. Primary Objective

    To find out whether giving Patiromer (an agent that binds potassium in the gut) to patients with worsening fluid overload (also known as congestion) due to heart failure who have a high blood potassium concentration will enable the use of higher doses of medicines called mineralo-corticoid antagonists (namely spironolactone or eplerenone) and whether this will reduce the rate of worsening heart failure [defined as a composite of need for diuretic injections for heart failure after discharge from the initial episode of care], re-hospitalisation for worsening heart failure or deaths for reasons other than cancer (treatment is not expected to influence cancer rates or cancer deaths).

    Patients will be randomly assigned to receive Patiromer (+ high-dose MRA) or not (+ standard-dose MRA) and outcomes compared. Both patients and investigators will be aware of which group they are assigned to. There is no placebo.

    B. Other Primary Objectives

    For The Registry:
    To assess
    E.2.2Secondary objectives of the trial
    For The Registry:
    To describe the characteristics and outcome of participants with worsening heart failure who require higher doses of diuretics to control worsening symptoms and signs of fluid overload (congestion).

    For The Randomised Trial until Day 60:
    To find out whether people with worsening congestion due to heart failure and a high blood potassium who are randomised to patiromer receive higher doses of MRA and have less severe symptoms and signs of congestion, quality of life and hospital length of stay compared to patients assigned to those who are randomised to standard care.

    Randomised Trial including All Follow-up:
    To find out whether people with worsening congestion due to heart failure and a high blood potassium who are randomised to patiromer receive higher doses of MRA, have improved long-term quality of life, spend less time in hospital and have lower all-cause mortality compared to patients assigned to those who are randomised to standard care.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For the Screening Log (no linkage to electronic medical records or follow-up)
    1. ≥18 years
    2. Heart failure in the investigators opinion (new onset or decompensated chronic heart failure)
    3. Planned to receive >=80mg/day of furosemide or equivalent (IV or oral) in the next 24 hours.
    4. Worsening symptoms & signs of congestion in the prior 10 days requiring at least one of the following:
    a) hospitalisation
    b) administration of intravenous diuretics
    c) doubling of the dose of loop diuretic (e.g.:- from 40mg to 80mg/day or 80mg to 160mg/day)
    d) addition of a thiazide diuretic to treatment with a loop diuretic

    For the Consented Registry (with linkage to electronic medical records)
    1. Fulfils the criteria for the screening log
    2. Able and willing to provide written informed consent for registry participation

    For Randomised Trial Run-in
    1. Fulfils criteria for the consented registry
    2. Clinical diagnosis of heart failure for at least 4 weeks
    3. Congestion as shown by at least one of the following:
    a) Peripheral oedema
    b) Raised venous pressure
    c) Inferior vena cava diameter >20mm
    4. Cardiac dysfunction documented by at least one of the following in the previous three years:
    a) Left ventricular ejection fraction <50% or a report of moderate or severe left ventricular dysfunction
    b) Left atrial diameter >3.0cm/m2 (body surface area)
    c) Elevated BNP or NT-proBNP
    (i) BNP >150ng/L if in sinus rhythm or >450ng/L if not in sinus rhythm
    (ii) NT-proBNP >500ng/L if in sinus rhythm and >1500ng/L if not in sinus rhythm
    5. Able and willing to provide written informed consent for the randomised trial

    For Randomisation
    1. Serum potassium >5.0mmol/L
    • Patients with a serum potassium >5.0mmol/L may be randomised immediately unless they have severe hyperkalaemia requiring, in the investigators opinion, intravenous treatment or a potassium binding agent.
    • Severe hyperkalaemia should be managed according to the UK Renal Association guidelines of 2014 (https://renal.org/wp-content/uploads/2017/06/hyperkalaemia-guideline-1.pdf). Participants may be reconsidered for the trial once such interventions are no longer considered necessary.
    • Patients with a serum potassium ≤5.0mmol/L should be initiated on spironolactone or have the dose increased up to 100mg/day and randomised only if serum potassium exceeds 5.0mmol/L. Those intolerant of or unwilling to take spironolactone should be offered eplerenone titrated to a maximum dose of 50mg/day.
    • A run-in period of up to 35 days is permitted (the run-in period will usually occur during hospitalisation or a course of day-care or intense management).
    2. After ingestion of a test-dose of patiromer,
    • the patient is willing to continue in the trial
    • the investigator considers the patient can follow instructions on preparing patiromer.
    E.4Principal exclusion criteria
    For the Screening Log and Consented Registry
    - None

    For the Randomised Trial
    1. eGFR <30ml/minute/1.73m2 (if clinically appropriate, the dose of other agents such as loop diuretics, ACE inhibitors, angiotensin receptor blockers, beta-blockers and sacubitril-valsartan may be adjusted to allow eGFR to increase)
    2. Systolic BP <90mmHg
    3. Uncorrected valve disease as the main cause of heart failure in the investigators opinion
    4. Hepatic encephalopathy or known severe liver disease
    5. Infection currently requiring intravenous antibiotics or temperature >38oC
    6. Myocardial ischaemia currently requiring intravenous therapy or coronary intervention or coronary intervention in the previous 7 days
    7. Arrhythmia requiring urgent cardioversion or intravenous therapy
    8. Severe hyperkalaemia requiring, in the investigator’s opinion, intravenous treatment or a potassium-binding agent
    9. The patient is already receiving a potassium-binding agent (this includes patiromer) or the treating physician has already decided to use one.
    10. Known hypersensitivity to patiromer or any of the excipients.
    11. Known intolerance to spironolactone or eplerenone (not including hyperkalaemia)
    12. Known hypersensitivity to the active substance or excipients of spironolactone and eplerenone as per the current Summary of Product Characteristics (Note: actual medicine supplied to participants will vary depending on local arrangements)
    13. Women of child bearing potential. For the purposes of this trial this means any woman aged <60 years unless they have had a hysterectomy or bilateral tubal ligation or are aged >50 years and have undergone the menopause and had amenorrhea for at least 3 years
    14. Patients taking the following systemic medicines:
    • strong inhibitors of CYP 3A4 (e.g. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone)
    • Lithium
    • Tacrolimus or Cyclosporin
    15. The combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB)
    16. Rare hereditary problems of galactose or fructose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
    17. Known amyloid heart disease
    18. Cancer likely to cause death or major disability within the next three years
    19. Patients requiring mechanical circulatory support
    20. Patients who do not develop a serum potassium >5.0mmol/L despite receiving up to 100mg/day of spironolactone or 50mg/day of eplerenone during the run in phase.
    E.5 End points
    E.5.1Primary end point(s)
    Composite of time to need for IV diuretics for worsening or recalcitrant heart failure (subsequent to discharge from index episode of care), (re-)hospitalisation for worsening heart failure or non-cancer deaths. The study is powered on time-to-first event but analysis will include first and recurrent events for the primary endpoint.

    There is also a primary endpoint for the registry:
    # Time to first (re)-hospitalisation or death

    And an ancillary primary endpoint at Day 60:
    # Congestion Index

    E.5.1.1Timepoint(s) of evaluation of this end point
    The trial is event driven and will continue until 719 primary outcome events have occurred overall in the two randomised groups.

    The registry outcome will be evaluated periodically up to 10 years.

    Congestion Index will be evaluated at Day 60.
    E.5.2Secondary end point(s)
    RANDOMISED TRIAL (LONG-TERM FOLLOW-UP):
    # Mortality (all-cause; non-cancer; cardiovascular)
    # Days lost to hospitalisation for heart failure or non-cancer mortality
    # Days lost to any hospitalisation or death
    # Proportion alive & well (defined by KCCQ)
    # Quality adjusted life-years using EQ5D
    # Dose of MRA
    # Dose of oral diuretics other than MRA
    # NYHA
    # Patient Global Assessment (PGA)

    UNTIL DAY 60:
    # Dose of MRA
    # Congestion Index
    # Individual Components of Congestion Index
    # Days dead or hospitalised
    # Quality of Life (EQ5D & KCCQ)
    # NYHA
    # Patient Global Assessment (PGA)

    REGISTRY:
    # Composite of time to cardiovascular (re)-hospitalisation or non-cancer death
    # Composite of time to heart failure (re)-hospitalisation or non-cancer death
    # Incidence rate for hospitalisation (all-causes, cardiovascular causes, heart failure causes, cancer causes – separately)
    # Time to death (all-causes, cardiovascular causes, heart failure causes, cancer causes, and other)
    E.5.2.1Timepoint(s) of evaluation of this end point
    RANDOMISED TRIAL (LONG-TERM FOLLOW-UP):
    # Mortality (all-cause; non-cancer; cardiovascular) - END TRIAL
    # Days lost to hospitalisation for heart failure/non-cancer mortality - 12 MONTH
    # Days lost to any hospitalisation/death - 12 MONTH
    # Proportion alive & well (defined by KCCQ)- 12 MONTH
    # QUALY using EQ5D - END OF TRIAL
    # Dose MRA - 6&12 MONTH
    # Dose oral diuretics other than MRA - 6&12 MONTH
    # NYHA - 6&12 MONTH
    # Patient Global Assessment (PGA)- 6&12 MONTH

    UNTIL DAY 60:
    # Dose MRA - DAYS 7&60
    # Congestion Index (CI) - DAYS 7&60
    # Individual components of CI - DAYS 7&60
    # Days dead/hospitalised - DAY 60
    # Quality of Life (EQ5D & KCCQ)- DAYS 7&60
    # NYHA - DAYS 7&60
    # PGA - DAYS 7&60

    REGISTRY: PERIODICALLY UP TO 10 YEARS
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Test: Combination of Partiromer and Spironolactone or Eplerenone
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparator: Spironolactone or Eplerenone
    E.8.2.4Number of treatment arms in the trial2
    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 concerned100
    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 No
    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
    End of trial is final database lock. After last patient last visit record linkages will have to be carried out, all study outcomes identified and adjudicated.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1300
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state2000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 2000
    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)
    At the end of the trial, participants will be returned to usual care as defined by local and national guidelines at that time. The results of the trial may of course have an impact on these guidelines and the future care of patients with heart failure.

    Spironolactone and eplerenone are generic medicines that are already widely prescribed.

    Patiromer is licensed for use in the UK but is not currently recommended in guidelines.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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