Chronic Heart FailureESTIANCT06117722
TorasEmide Induced Effect on QoL and Clinical parameterS in paTients With chronIc heArt Failure Receiving Eplerenone.
An observational study of Chronic Heart Failure, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial summary
Heart failure (HF) is a multisystemic disorder characterized by marked disturbances in the physiology of the circulatory system and a multitude of structural and functional changes in the myocardium that adversely affect the systolic function and diastolic filling of the heart. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Eplerenone torasemide in chronic heart failure
- How many people
- 210 participants
- Where
- 1 siteGreece
- Study dates
- 6 Mar 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a diagnosis of Chronic Heart Failure (CHF) who are on treatment with torasemide added on to eplerenone treatment, from 1 to 7 days before study initiation.
Who may be able to join
- Adult patients (≥ 18 years) with a diagnosis of Chronic Heart Failure (CHF)
- Patients who are on treatment with torasemide added on to eplerenone treatment, from 1 to 7 days before study initiation.
- Patients who are able to provide informed consent and follow study procedures and requirements.
Who cannot join
- Patients with hypersensitivity to the active substance of torasemide, sulfonylureas or to any of the excipients mentioned in torasemide SmPC.
- Patients with renal failure with anuria.
- Patients in hepatic coma, or pro-coma.
- Patients with intolerance to galactose, complete lactase deficiency or glucose-galactose malabsorption.
- Patients with hypotension.
- Patients with cardiac arrhythmias.
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- Patients with parallel treatment with aminoglycosides or cephalosporins.
- Patients with kidney dysfunction due to drugs that cause kidney damage.
- The addition during the study of other drugs with a direct effect on diuresis (such as other diuretics or SGLT2 inhibitors).
- Patients who are unable to comply with the study protocol procedures and requirements.
Trial locations and contacts
1 site in 1 country.
Alexandros Ginis contact
Greece1 site, 1 recruiting
- Recruiting
ATTIKON University Hospital
Athens, Attica, 12462
John Parissis, MD, +302105831700, jparissis@yahoo.com
About this study
Official title: ESTIA: TorasEmide Induced Effect on Quality of Life and Clinical parameterS in paTients With chronIc heArt Failure Receiving Eplerenone. Multicenter, Non-interventional, Prospective, Observational Clinical Study.
Heart failure (HF) is a multisystemic disorder characterized by marked disturbances in the physiology of the circulatory system and a multitude of structural and functional changes in the myocardium that adversely affect the systolic function and diastolic filling of the heart. Heart failure is not a single pathologic diagnosis, but a clinical syndrome consisting of cardiac symptoms (eg, dyspnea, edema of the lower extremities, and fatigue) that may be accompanied by signs (eg, increased jugular venous pressure and peripheral edema).The diagnosis of CKD becomes more likely in patients with a history of myocardial infarction (MI), arterial hypertension, coronary artery disease (CHD), diabetes mellitus, alcohol abuse, chronic kidney disease (CKD), cardiotoxic chemotherapy, and in patients with a family history of cardiomyopathy or of sudden death. The diagnosis of HF requires the presence of HF symptoms and/or signs and objective evidence of cardiac dysfunction.
The main symptoms of HF are symptoms such as shortness of breath at rest or during exercise, difficulty breathing (dyspnea), rapid breathing (tachypnea), difficulty breathing when bending over (bendopnea), orthopnea, paroxysmal nocturnal dyspnea, fatigue , weight gain or weight loss, swelling (of the extremities, scrotum or elsewhere), wheezing, palpitations, syncope, history of Cheyne Stokes breathing during sleep (often reported by the family rather than the patient), cough, drowsiness.
Read more
The simplest terminology used to describe HF severity is the New York Heart Association (NYHA) functional classification based on symptom severity and physical activity.
In Greece, it is estimated that the number of patients suffering from HF is 200,000.
In the vast majority of cases, transthoracic echocardiography is the initial cardiac imaging test used to evaluate patients with newly diagnosed or suspected heart failure. Echocardiography is particularly suitable for the evaluation of myocardial structure and function, valvular function and hemodynamic parameters .
Read the detailed description
Eplerenone is more specific in blocking aldosterone and therefore causes less gynecomastia. Eplerenone is indicated in addition to standard therapy including β-blockers to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤40%) and clinical evidence of heart failure after recent myocardial infarction. In addition, eplerenone is indicated in standard optimal therapy to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) HF and with left ventricular systolic dysfunction (LVEF ≤ 30%).
Caution should be exercised when MRAs are used in patients with renal impairment and those with serum potassium concentrations >5.0 mmol/L.
Diuretics are drugs that are recommended or should be considered in selected HF patients with reduced ejection fraction. The goal of diuretic therapy is to achieve and maintain euvolemia with the lowest dose of diuretics.
Loop diuretics are recommended to reduce signs and/or symptoms of congestion in patients with HFrEF.
Transition to oral therapy should begin when the patient's clinical condition is stable .
Torasemide, one of the loop diuretics, is indicated in the treatment of edema due to congestive heart failure. The usual starting dose is 10 or 20 mg once a day. If the diuretic response is inadequate, the dose should be approximately doubled until an adequate response is achieved .
Among the potential advantages of torasemide in the treatment of HF are its beneficial pharmacological properties, which make it more suitable for the management of congestion ).
Torasemide may be less susceptible to diuretic resistance, has a prolonged half-life (3.5 hours), prolonged duration of effect (6-16 hours), and is less prone to hypokalemia .
- Conditions
- Chronic Heart Failure
- Being tested
- Eplerenone torasemide in chronic heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eplerenone torasemide in chronic heart failureOther
Heart Failure patients treated with eplerenone and torasemide
What is being measured
The primary outcome is the main question the study is designed to answer.
Minnesota Living with Heart Failure (MLHF)
The change in the disease specific questionnaire - Minnesota Living with Heart Failure (MLHF) - score from baseline to 6 months of treatment and between the visits.
Measured: 6 months
Secondary outcomes (6)
CHQ-SAS (Chronic Heart failure Questionnaire - Self Administered format, Standardized questions)
Changes from baseline in the CHQ-SAS (Chronic Heart failure Questionnaire - Self Administered format, Standardized questions) to assess the degree of dyspnoea, between the visits and at 6 months from treatment initiation.
Changes from baseline in patients' New York Heart Association (NYHA) classification between the visits and at 6 months.
Measured: 6 months
New York Heart Association (NYHA) classification
Changes from baseline in patients' New York Heart Association (NYHA) classification between the visits and at 6 months.
Measured: 6 months
Morisky Medication Adherence Scale (MMAS-8)
The score of the 8-item Morisky Medication Adherence Scale (MMAS-8) at 3 and 6 months from treatment initiation and its change between visits.
Measured: 6 months
Body weight
The change in patients' body weight from baseline, between the visits and at 6-months from treatment initiation.
Measured: 6 months
Dosage scheme
The record of torasemide titration.
Measured: 6 months
Number of Adverse Events
The record of Adverse Events during the study conduct.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start6 Mar 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandros Ginis, MD, Study director, Elpen Pharmaceutical Industry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117722
- Sponsor's protocol ID
- 2023-TOREPL-EL-184
- Acronym
- ESTIA
- Status last verified
- Feb 2024
- First submitted
- 31 Oct 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diwan, A. &. (2019). SECTION I Basic Mechanisms of Heart Failure. Heart Failure: A Companion to Braunwald's Heart Disease, 1.
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
PubMed 34447992Lam CSP, Voors AA, Piotr P, McMurray JJV, Solomon SD. Time to rename the middle child of heart failure: heart failure with mildly reduced ejection fraction. Eur Heart J. 2020 Jul 1;41(25):2353-2355. doi: 10.1093/eurheartj/ehaa158. No abstract available.
PubMed 32227233Mant J, Doust J, Roalfe A, Barton P, Cowie MR, Glasziou P, Mant D, McManus RJ, Holder R, Deeks J, Fletcher K, Qume M, Sohanpal S, Sanders S, Hobbs FD. Systematic review and individual patient data meta-analysis of diagnosis of heart failure, with modelling of implications of different diagnostic strategies in primary care. Health Technol Assess. 2009 Jul;13(32):1-207, iii. doi: 10.3310/hta13320.
PubMed 19586584Davie AP, Francis CM, Caruana L, Sutherland GR, McMurray JJ. Assessing diagnosis in heart failure: which features are any use? QJM. 1997 May;90(5):335-9. doi: 10.1093/qjmed/90.5.335.
PubMed 9205668Oudejans I, Mosterd A, Bloemen JA, Valk MJ, van Velzen E, Wielders JP, Zuithoff NP, Rutten FH, Hoes AW. Clinical evaluation of geriatric outpatients with suspected heart failure: value of symptoms, signs, and additional tests. Eur J Heart Fail. 2011 May;13(5):518-27. doi: 10.1093/eurjhf/hfr021. Epub 2011 Mar 19.
PubMed 21422000Kelder JC, Cramer MJ, van Wijngaarden J, van Tooren R, Mosterd A, Moons KG, Lammers JW, Cowie MR, Grobbee DE, Hoes AW. The diagnostic value of physical examination and additional testing in primary care patients with suspected heart failure. Circulation. 2011 Dec 20;124(25):2865-73. doi: 10.1161/CIRCULATIONAHA.111.019216. Epub 2011 Nov 21.
PubMed 22104551Caraballo C, Desai NR, Mulder H, Alhanti B, Wilson FP, Fiuzat M, Felker GM, Pina IL, O'Connor CM, Lindenfeld J, Januzzi JL, Cohen LS, Ahmad T. Clinical Implications of the New York Heart Association Classification. J Am Heart Assoc. 2019 Dec 3;8(23):e014240. doi: 10.1161/JAHA.119.014240. Epub 2019 Nov 27.
PubMed 31771438Conrad N, Judge A, Tran J, Mohseni H, Hedgecott D, Crespillo AP, Allison M, Hemingway H, Cleland JG, McMurray JJV, Rahimi K. Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals. Lancet. 2018 Feb 10;391(10120):572-580. doi: 10.1016/S0140-6736(17)32520-5. Epub 2017 Nov 21.
PubMed 29174292Dunlay SM, Roger VL. Understanding the epidemic of heart failure: past, present, and future. Curr Heart Fail Rep. 2014 Dec;11(4):404-15. doi: 10.1007/s11897-014-0220-x.
PubMed 25182014Roth GA, Forouzanfar MH, Moran AE, Barber R, Nguyen G, Feigin VL, Naghavi M, Mensah GA, Murray CJ. Demographic and epidemiologic drivers of global cardiovascular mortality. N Engl J Med. 2015 Apr 2;372(14):1333-41. doi: 10.1056/NEJMoa1406656.
PubMed 25830423Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.
PubMed 28785469Meyer S, Brouwers FP, Voors AA, Hillege HL, de Boer RA, Gansevoort RT, van der Harst P, Rienstra M, van Gelder IC, van Veldhuisen DJ, van Gilst WH, van der Meer P. Sex differences in new-onset heart failure. Clin Res Cardiol. 2015 Apr;104(4):342-50. doi: 10.1007/s00392-014-0788-x. Epub 2014 Nov 15.
PubMed 25398254Brouwers FP, de Boer RA, van der Harst P, Voors AA, Gansevoort RT, Bakker SJ, Hillege HL, van Veldhuisen DJ, van Gilst WH. Incidence and epidemiology of new onset heart failure with preserved vs. reduced ejection fraction in a community-based cohort: 11-year follow-up of PREVEND. Eur Heart J. 2013 May;34(19):1424-31. doi: 10.1093/eurheartj/eht066. Epub 2013 Mar 6.
PubMed 23470495GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
PubMed 30496104
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESTIA: TorasEmide Induced Effect on Quality of Life and Clinical parameterS in paTients With chronIc heArt Failure Receiving Eplerenone. Multicenter, Non-interventional, Prospective, Observational Clinical Study.
- ClinicalTrials.gov ID
- NCT06117722
- Acronym / sponsor ID
- ESTIA / 2023-TOREPL-EL-184
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure (HF) is a multisystemic disorder characterized by marked disturbances in the physiology of the circulatory system and a multitude of structural and functional changes in the myocardium that adversely affect the systolic function and diastolic filling of the heart. Heart failure is not a single pathologic diagnosis, but a clinical syndrome consisting of cardiac symptoms (eg, dyspnea, edema of the lower extremities, and fatigue) that may be accompanied by signs (eg, increased jugular venous pressure and peripheral edema).The diagnosis of CKD becomes more likely in patients with a history of myocardial infarction (MI), arterial hypertension, coronary artery disease (CHD), diabetes mellitus, alcohol abuse, chronic kidney disease (CKD), cardiotoxic chemotherapy, and in patients with a family history of cardiomyopathy or of sudden death. The diagnosis of HF requires the presence of HF symptoms and/or signs and objective evidence of cardiac dysfunction.
The main symptoms of HF are symptoms such as shortness of breath at rest or during exercise, difficulty breathing (dyspnea), rapid breathing (tachypnea), difficulty breathing when bending over (bendopnea), orthopnea, paroxysmal nocturnal dyspnea, fatigue , weight gain or weight loss, swelling (of the extremities, scrotum or elsewhere), wheezing, palpitations, syncope, history of Cheyne Stokes breathing during sleep (often reported by the family rather than the patient), cough, drowsiness.
The simplest terminology used to describe HF severity is the New York Heart Association (NYHA) functional classification based on symptom severity and physical activity.
In Greece, it is estimated that the number of patients suffering from HF is 200,000.
In the vast majority of cases, transthoracic echocardiography is the initial cardiac imaging test used to evaluate patients with newly diagnosed or suspected heart failure. Echocardiography is particularly suitable for the evaluation of myocardial structure and function, valvular function and hemodynamic parameters .
Detailed description
Eplerenone is more specific in blocking aldosterone and therefore causes less gynecomastia. Eplerenone is indicated in addition to standard therapy including β-blockers to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤40%) and clinical evidence of heart failure after recent myocardial infarction. In addition, eplerenone is indicated in standard optimal therapy to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) HF and with left ventricular systolic dysfunction (LVEF ≤ 30%).
Caution should be exercised when MRAs are used in patients with renal impairment and those with serum potassium concentrations >5.0 mmol/L.
Diuretics are drugs that are recommended or should be considered in selected HF patients with reduced ejection fraction. The goal of diuretic therapy is to achieve and maintain euvolemia with the lowest dose of diuretics.
Loop diuretics are recommended to reduce signs and/or symptoms of congestion in patients with HFrEF.
Transition to oral therapy should begin when the patient's clinical condition is stable .
Torasemide, one of the loop diuretics, is indicated in the treatment of edema due to congestive heart failure. The usual starting dose is 10 or 20 mg once a day. If the diuretic response is inadequate, the dose should be approximately doubled until an adequate response is achieved .
Among the potential advantages of torasemide in the treatment of HF are its beneficial pharmacological properties, which make it more suitable for the management of congestion ).
Torasemide may be less susceptible to diuretic resistance, has a prolonged half-life (3.5 hours), prolonged duration of effect (6-16 hours), and is less prone to hypokalemia .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a diagnosis of Chronic Heart Failure (CHF) who are on treatment with torasemide added on to eplerenone treatment, from 1 to 7 days before study initiation.
Key inclusion criteria (3 listed)
- Adult patients (≥ 18 years) with a diagnosis of Chronic Heart Failure (CHF)
- Patients who are on treatment with torasemide added on to eplerenone treatment, from 1 to 7 days before study initiation.
- Patients who are able to provide informed consent and follow study procedures and requirements.
Key exclusion criteria (10 listed)
- Patients with hypersensitivity to the active substance of torasemide, sulfonylureas or to any of the excipients mentioned in torasemide SmPC.
- Patients with renal failure with anuria.
- Patients in hepatic coma, or pro-coma.
- Patients with intolerance to galactose, complete lactase deficiency or glucose-galactose malabsorption.
- Patients with hypotension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eplerenone torasemide in chronic heart failureHeart Failure patients treated with eplerenone and torasemide | Other | – |
Primary outcome
Minnesota Living with Heart Failure (MLHF)
Time frame: 6 months
The change in the disease specific questionnaire - Minnesota Living with Heart Failure (MLHF) - score from baseline to 6 months of treatment and between the visits.
6 secondary outcomes
CHQ-SAS (Chronic Heart failure Questionnaire - Self Administered format, Standardized questions)
Time frame: 6 months
New York Heart Association (NYHA) classification
Time frame: 6 months
Morisky Medication Adherence Scale (MMAS-8)
Time frame: 6 months
Body weight
Time frame: 6 months
Dosage scheme
Time frame: 6 months
Number of Adverse Events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- BackgroundDiwan, A. &. (2019). SECTION I Basic Mechanisms of Heart Failure. Heart Failure: A Companion to Braunwald's Heart Disease, 1.
- Background: PubMed 34447992McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Background: PubMed 32227233Lam CSP, Voors AA, Piotr P, McMurray JJV, Solomon SD. Time to rename the middle child of heart failure: heart failure with mildly reduced ejection fraction. Eur Heart J. 2020 Jul 1;41(25):2353-2355. doi: 10.1093/eurheartj/ehaa158. No abstract available.
- Background: PubMed 19586584Mant J, Doust J, Roalfe A, Barton P, Cowie MR, Glasziou P, Mant D, McManus RJ, Holder R, Deeks J, Fletcher K, Qume M, Sohanpal S, Sanders S, Hobbs FD. Systematic review and individual patient data meta-analysis of diagnosis of heart failure, with modelling of implications of different diagnostic strategies in primary care. Health Technol Assess. 2009 Jul;13(32):1-207, iii. doi: 10.3310/hta13320.
- Background: PubMed 9205668Davie AP, Francis CM, Caruana L, Sutherland GR, McMurray JJ. Assessing diagnosis in heart failure: which features are any use? QJM. 1997 May;90(5):335-9. doi: 10.1093/qjmed/90.5.335.
- Background: PubMed 21422000Oudejans I, Mosterd A, Bloemen JA, Valk MJ, van Velzen E, Wielders JP, Zuithoff NP, Rutten FH, Hoes AW. Clinical evaluation of geriatric outpatients with suspected heart failure: value of symptoms, signs, and additional tests. Eur J Heart Fail. 2011 May;13(5):518-27. doi: 10.1093/eurjhf/hfr021. Epub 2011 Mar 19.
- Background: PubMed 22104551Kelder JC, Cramer MJ, van Wijngaarden J, van Tooren R, Mosterd A, Moons KG, Lammers JW, Cowie MR, Grobbee DE, Hoes AW. The diagnostic value of physical examination and additional testing in primary care patients with suspected heart failure. Circulation. 2011 Dec 20;124(25):2865-73. doi: 10.1161/CIRCULATIONAHA.111.019216. Epub 2011 Nov 21.
- Background: PubMed 31771438Caraballo C, Desai NR, Mulder H, Alhanti B, Wilson FP, Fiuzat M, Felker GM, Pina IL, O'Connor CM, Lindenfeld J, Januzzi JL, Cohen LS, Ahmad T. Clinical Implications of the New York Heart Association Classification. J Am Heart Assoc. 2019 Dec 3;8(23):e014240. doi: 10.1161/JAHA.119.014240. Epub 2019 Nov 27.
- Background: PubMed 29174292Conrad N, Judge A, Tran J, Mohseni H, Hedgecott D, Crespillo AP, Allison M, Hemingway H, Cleland JG, McMurray JJV, Rahimi K. Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals. Lancet. 2018 Feb 10;391(10120):572-580. doi: 10.1016/S0140-6736(17)32520-5. Epub 2017 Nov 21.
- Background: PubMed 25182014Dunlay SM, Roger VL. Understanding the epidemic of heart failure: past, present, and future. Curr Heart Fail Rep. 2014 Dec;11(4):404-15. doi: 10.1007/s11897-014-0220-x.
- Background: PubMed 25830423Roth GA, Forouzanfar MH, Moran AE, Barber R, Nguyen G, Feigin VL, Naghavi M, Mensah GA, Murray CJ. Demographic and epidemiologic drivers of global cardiovascular mortality. N Engl J Med. 2015 Apr 2;372(14):1333-41. doi: 10.1056/NEJMoa1406656.
- Background: PubMed 28785469Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandros Ginis contact
Alexandros Ginis, MD study director
Elpen Pharmaceutical Industry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Polyanthi Papanastasiou (+302111865777, p.papanastasiou@elpen.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minnesota Living with Heart Failure (MLHF) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06117722, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.