Heart Failure With Reduced Ejection FractionPREVALENTNCT03644446
Bisoprolol Plasma Residual Concentrations in Chronic Heart Failure
An observational study of Heart Failure With Reduced Ejection Fraction, run by University Hospital, Caen at 1 site in France.
Trial summary
This study evaluate the dosage of bisoprolol plasma residual concentrations in chronic heart failure with mild to reduced ejection fraction adult patients by dose and renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Bisoprolol plasma residual concentration dosage
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2017to 2 Nov 2020
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive ambulatory chronic HFrEF patients followed at the CHU de Caen, treated with maximum tolerated dose of bisoprolol. Patients can benefit of other HFrEF recommended treatment at the exception of ivabradine that would confound the bisoprolol effect on heart rate. Patients will be subsequently studied by renal function (altered if creatinine clearance < 30mL/min, mild altered between 30-60mL/min, normal > 60mL/min as estimated by the CKD-EPI formula) and bisoprolol dose (5, 7.5 or 10mg).
Who may be able to join
- Consecutive ambulatory patients with chronic heart failure with mild to reduced ejection fraction (LVEF < 50%) at the CHU de Caen
- Aged 18 y.o. or older
- With a stable heart failure (see exclusion criteria)
- At the maximum tolerated dose of bisoprolol for at least one week (maximum dose reached without adverse tolerance event: orthostatic hypotension, symptomatic bradycardia, fatigue related to the treatment)
Who cannot join
- Unstable HF, that are patients who presented in the last 3 months before inclusion an hospitalization for any cardiovascular event including HF, new onset or worsening of HF or coronary artery disease symptoms
- Patient refusing to participate
- Patients with a non maximum tolerated dose of bisoprolol
- Patients with ivabradine intakes
- Body weight < 60kg or > 100kg
- Severe liver insufficiency
- Pregnancy
- Liberty deprived patients
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Alexandre Joachim
Caen, Basse Normandie, 14000
Joachim Alexandre, MD, +33231064670, alexandre-j@chu-caen.fr
About this study
Official title: Bisoprolol Plasma Residual Concentrations for the Optimization of Drug Management in Heart Failure With Mild to Reduced Ejection Fraction
This study evaluate the dosage of bisoprolol plasma residual concentrations in chronic heart failure with mild to reduced ejection fraction adult patients by dose and renal function.
Read the detailed description
The clinical relevance of bisoprolol plasma residual concentration in the management of HF medical therapy and the impact of renal function on reaching the maximum tolerated dose has never been studied. The investigators will perform an observational study to answer this issue.
In this study, there will be no changes of the doses of bisoprolol, whatever the bisoprolol plasma concentration, with the exception of vital threatening concentrations. This study is a pilot study.
Participants will be consecutive ambulatory chronic heart failure patients followed at the CHU de Caen, treated with maximum tolerated dose of bisoprolol with mild to reduced ejection fraction. Participants can benefit of the other heart failure recommended treatment at the exception of ivabradine that would confound the bisoprolol effect on heart rate. Participants will be subsequently studied by renal function.
Patients will be followed at one year with the electronic health record of the CHU de Caen for clinical events.
- Being tested
- Bisoprolol plasma residual concentration dosage
- Keywords
- Bisoprolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisoprolol plasma residual concentration dosageBiological
Bisoprolol plasma residual concentration dosage will be subsequently studied by renal function (altered if creatinine clearance < 30mL/min, mild altered between 30-60mL/min, normal > 60mL/min as estimated by the CKD-EPI formula)
| Study group | Role | What they receive |
|---|---|---|
| Bisoprolol 5mg | Chronic heart failure with mild to reduced ejection fraction adult patients with bisoprolol intakes at 5mg (patient's maximum tolerated dose), stable, with a left ventricular ejection fraction < 50%. Consecutive patients at the CHU de Caen. Receives: Biological: Bisoprolol plasma residual concentration dosage | |
| Bisoprolol 7.5mg | Chronic heart failure with mild to reduced ejection fraction adult patients with bisoprolol intakes at 7.5mg (patient's maximum tolerated dose), stable, with a left ventricular ejection fraction < 50%. Consecutive patients at the CHU de Caen. Receives: Biological: Bisoprolol plasma residual concentration dosage | |
| Bisoprolol 10mg | Chronic heart failure with mild to reduced ejection fraction adult patients with bisoprolol intakes at 10mg (patient's maximum tolerated dose), stable, with a left ventricular ejection fraction < 50%. Consecutive patients at the CHU de Caen. Receives: Biological: Bisoprolol plasma residual concentration dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bisoprolol residual plasma concentration by dose and renal function
Bisoprolol plasma residual concentrations will be performed by liquid chromatography with tandem mass spectrometry (LC-MS/MS) with simple precipitation of proteins with acetonitrile, as described by Liu et al. The quantification will be in positive mode by multiple reaction monitoring with the following transitions: 326 to 116 for bisoprolol and 256 to 167 for diphenhydramine (control). Bisoprolol concentrations will be expressed in µg/L.
Measured: At the time of inclusion
Secondary outcomes (11)
Clinical parameters at the time of inclusion
Heart rate in beats per minute (bpm). Heart rate will be studied as a continous outcome and as a dichotomous outcome for efficacy. The efficacy parameter cutoff is a heart rate < 70bpm.
Measured: At the time of inclusion
Clinical parameters at the time of inclusion
Systolic and diastolic blood pressure (in mmHg)
Measured: At the time of inclusion
Clinical parameters at the time of inclusion
Tolerance : presence of any new symptom that requires a dose lowering or discontinuation of bisoprolol (dichotomous outcome) or symptomatic orthostatic hypotension
Measured: At the time of inclusion
Clinical parameters at the time of inclusion
Tolerance : presence of a symptomatic orthostatic hypotension (dichotomous outcome) that is defined as a decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within three minutes of standing when compared with blood pressure from the sitting or supine position.
Measured: At the time of inclusion
Biological assessment
Routine biological evaluation : creatinine (in µmol/L)
Measured: At the time of inclusion
Biological assessment
Routine biological evaluation : Brain Natriuretic Peptide (in pg/mL)
Measured: At the time of inclusion
Biological assessment
Galectin-3 (in ng/mL)
Measured: At the time of inclusion
Clinical outcomes at one year
Heart failure symptoms worsening (dichotomous variable)
Measured: At one year follow-up
Clinical outcomes at one year
Hospitalization for heart failure (dichotomous variable)
Measured: At one year follow-up
Clinical outcomes at one year
Death from any cause (dichotomous variable)
Measured: At one year follow-up
Clinical outcomes at one year
Bisoprolol dose modification (categorical variable : dose increased, dose decreased, dose unchanged and quantitative analysis of mean change between bisoprolol inclusion dose and bisoprolol dose at one year).
Measured: At one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start2 Nov 2017
- Primary completion2 Nov 2019 (estimated)
- Study completion2 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644446
- Sponsor's protocol ID
- DC-2016-2725
- Acronym
- PREVALENT
- Status last verified
- Jul 2018
- First submitted
- 13 Aug 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McMurray JJ, Stewart S. Epidemiology, aetiology, and prognosis of heart failure. Heart. 2000 May;83(5):596-602. doi: 10.1136/heart.83.5.596. No abstract available.
PubMed 10768918Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart. 2007 Sep;93(9):1137-46. doi: 10.1136/hrt.2003.025270.
PubMed 17699180Stewart S, MacIntyre K, Hole DJ, Capewell S, McMurray JJ. More 'malignant' than cancer? Five-year survival following a first admission for heart failure. Eur J Heart Fail. 2001 Jun;3(3):315-22. doi: 10.1016/s1388-9842(00)00141-0.
PubMed 11378002Stewart S, Ekman I, Ekman T, Oden A, Rosengren A. Population impact of heart failure and the most common forms of cancer: a study of 1 162 309 hospital cases in Sweden (1988 to 2004). Circ Cardiovasc Qual Outcomes. 2010 Nov;3(6):573-80. doi: 10.1161/CIRCOUTCOMES.110.957571. Epub 2010 Oct 5.
PubMed 20923990Jhund PS, Macintyre K, Simpson CR, Lewsey JD, Stewart S, Redpath A, Chalmers JW, Capewell S, McMurray JJ. Long-term trends in first hospitalization for heart failure and subsequent survival between 1986 and 2003: a population study of 5.1 million people. Circulation. 2009 Feb 3;119(4):515-23. doi: 10.1161/CIRCULATIONAHA.108.812172. Epub 2009 Jan 19.
PubMed 19153268Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. No abstract available.
PubMed 18799522Bristow MR. Treatment of chronic heart failure with beta-adrenergic receptor antagonists: a convergence of receptor pharmacology and clinical cardiology. Circ Res. 2011 Oct 28;109(10):1176-94. doi: 10.1161/CIRCRESAHA.111.245092.
PubMed 22034480The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet. 1999 Jan 2;353(9146):9-13.
PubMed 10023943Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999 Jun 12;353(9169):2001-7.
PubMed 10376614Hjalmarson A, Goldstein S, Fagerberg B, Wedel H, Waagstein F, Kjekshus J, Wikstrand J, El Allaf D, Vitovec J, Aldershvile J, Halinen M, Dietz R, Neuhaus KL, Janosi A, Thorgeirsson G, Dunselman PH, Gullestad L, Kuch J, Herlitz J, Rickenbacher P, Ball S, Gottlieb S, Deedwania P. Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: the Metoprolol CR/XL Randomized Intervention Trial in congestive heart failure (MERIT-HF). MERIT-HF Study Group. JAMA. 2000 Mar 8;283(10):1295-302. doi: 10.1001/jama.283.10.1295.
PubMed 10714728Packer M, Fowler MB, Roecker EB, Coats AJ, Katus HA, Krum H, Mohacsi P, Rouleau JL, Tendera M, Staiger C, Holcslaw TL, Amann-Zalan I, DeMets DL; Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) Study Group. Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the carvedilol prospective randomized cumulative survival (COPERNICUS) study. Circulation. 2002 Oct 22;106(17):2194-9. doi: 10.1161/01.cir.0000035653.72855.bf.
PubMed 12390947Pasternak B, Mattsson A, Svanstrom H, Hviid A. Comparative effectiveness of bisoprolol and metoprolol succinate in patients with heart failure. Int J Cardiol. 2015;190:4-6. doi: 10.1016/j.ijcard.2015.03.441. Epub 2015 Apr 18. No abstract available.
PubMed 25912106Fiuzat M, Wojdyla D, Kitzman D, Fleg J, Keteyian SJ, Kraus WE, Pina IL, Whellan D, O'Connor CM. Relationship of beta-blocker dose with outcomes in ambulatory heart failure patients with systolic dysfunction: results from the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial. J Am Coll Cardiol. 2012 Jul 17;60(3):208-15. doi: 10.1016/j.jacc.2012.03.023. Epub 2012 May 2.
PubMed 22560018Fiuzat M, Wojdyla D, Pina I, Adams K, Whellan D, O'Connor CM. Heart Rate or Beta-Blocker Dose? Association With Outcomes in Ambulatory Heart Failure Patients With Systolic Dysfunction: Results From the HF-ACTION Trial. JACC Heart Fail. 2016 Feb;4(2):109-115. doi: 10.1016/j.jchf.2015.09.002. Epub 2015 Oct 28.
PubMed 26519996Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB. Dosing of beta-blocker therapy before, during, and after hospitalization for heart failure (from Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure). Am J Cardiol. 2008 Dec 1;102(11):1524-9. doi: 10.1016/j.amjcard.2008.07.045. Epub 2008 Sep 6.
PubMed 19026308
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bisoprolol Plasma Residual Concentrations for the Optimization of Drug Management in Heart Failure With Mild to Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT03644446
- Acronym / sponsor ID
- PREVALENT / DC-2016-2725
- Keywords
- Bisoprolol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 2 Nov 2019 (estimated)
- Study completion
- 2 Nov 2020 (estimated)
- First posted
- 23 Aug 2018 (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.
This study evaluate the dosage of bisoprolol plasma residual concentrations in chronic heart failure with mild to reduced ejection fraction adult patients by dose and renal function.
Detailed description
The clinical relevance of bisoprolol plasma residual concentration in the management of HF medical therapy and the impact of renal function on reaching the maximum tolerated dose has never been studied. The investigators will perform an observational study to answer this issue.
In this study, there will be no changes of the doses of bisoprolol, whatever the bisoprolol plasma concentration, with the exception of vital threatening concentrations. This study is a pilot study.
Participants will be consecutive ambulatory chronic heart failure patients followed at the CHU de Caen, treated with maximum tolerated dose of bisoprolol with mild to reduced ejection fraction. Participants can benefit of the other heart failure recommended treatment at the exception of ivabradine that would confound the bisoprolol effect on heart rate. Participants will be subsequently studied by renal function.
Patients will be followed at one year with the electronic health record of the CHU de Caen for clinical events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bisoprolol 5mg | – | Biological: Bisoprolol plasma residual concentration dosageChronic heart failure with mild to reduced ejection fraction adult patients with bisoprolol intakes at 5mg (patient's maximum tolerated dose), stable, with a left ventricular ejection fraction < 50%. Consecutive patients at the CHU de Caen. |
| Bisoprolol 7.5mg | – | Biological: Bisoprolol plasma residual concentration dosageChronic heart failure with mild to reduced ejection fraction adult patients with bisoprolol intakes at 7.5mg (patient's maximum tolerated dose), stable, with a left ventricular ejection fraction < 50%. Consecutive patients at the CHU de Caen. |
| Bisoprolol 10mg | – | Biological: Bisoprolol plasma residual concentration dosageChronic heart failure with mild to reduced ejection fraction adult patients with bisoprolol intakes at 10mg (patient's maximum tolerated dose), stable, with a left ventricular ejection fraction < 50%. Consecutive patients at the CHU de Caen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive ambulatory chronic HFrEF patients followed at the CHU de Caen, treated with maximum tolerated dose of bisoprolol. Patients can benefit of other HFrEF recommended treatment at the exception of ivabradine that would confound the bisoprolol effect on heart rate. Patients will be subsequently studied by renal function (altered if creatinine clearance < 30mL/min, mild altered between 30-60mL/min, normal > 60mL/min as estimated by the CKD-EPI formula) and bisoprolol dose (5, 7.5 or 10mg).
Key inclusion criteria (4 listed)
- Consecutive ambulatory patients with chronic heart failure with mild to reduced ejection fraction (LVEF < 50%) at the CHU de Caen
- Aged 18 y.o. or older
- With a stable heart failure (see exclusion criteria)
- At the maximum tolerated dose of bisoprolol for at least one week (maximum dose reached without adverse tolerance event: orthostatic hypotension, symptomatic bradycardia, fatigue related to the treatment)
Key exclusion criteria (8 listed)
- Unstable HF, that are patients who presented in the last 3 months before inclusion an hospitalization for any cardiovascular event including HF, new onset or worsening of HF or coronary artery disease symptoms
- Patient refusing to participate
- Patients with a non maximum tolerated dose of bisoprolol
- Patients with ivabradine intakes
- Body weight < 60kg or > 100kg
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 |
|---|---|---|
| Bisoprolol plasma residual concentration dosageBisoprolol plasma residual concentration dosage will be subsequently studied by renal function (altered if creatinine clearance < 30mL/min, mild altered between 30-60mL/min, normal > 60mL/min as estimated by the CKD-EPI formula) | Biological | Bisoprolol 10mg, Bisoprolol 5mg, Bisoprolol 7.5mg |
Primary outcome
Bisoprolol residual plasma concentration by dose and renal function
Time frame: At the time of inclusion
Bisoprolol plasma residual concentrations will be performed by liquid chromatography with tandem mass spectrometry (LC-MS/MS) with simple precipitation of proteins with acetonitrile, as described by Liu et al. The quantification will be in positive mode by multiple reaction monitoring with the following transitions: 326 to 116 for bisoprolol and 256 to 167 for diphenhydramine (control). Bisoprolol concentrations will be expressed in µg/L.
11 secondary outcomes
Clinical parameters at the time of inclusion
Time frame: At the time of inclusion
Clinical parameters at the time of inclusion
Time frame: At the time of inclusion
Clinical parameters at the time of inclusion
Time frame: At the time of inclusion
Clinical parameters at the time of inclusion
Time frame: At the time of inclusion
Biological assessment
Time frame: At the time of inclusion
Biological assessment
Time frame: At the time of inclusion
Biological assessment
Time frame: At the time of inclusion
Clinical outcomes at one year
Time frame: At one year follow-up
Clinical outcomes at one year
Time frame: At one year follow-up
Clinical outcomes at one year
Time frame: At one year follow-up
Clinical outcomes at one year
Time frame: At one year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Background: PubMed 10768918McMurray JJ, Stewart S. Epidemiology, aetiology, and prognosis of heart failure. Heart. 2000 May;83(5):596-602. doi: 10.1136/heart.83.5.596. No abstract available.
- Background: PubMed 17699180Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart. 2007 Sep;93(9):1137-46. doi: 10.1136/hrt.2003.025270.
- Background: PubMed 11378002Stewart S, MacIntyre K, Hole DJ, Capewell S, McMurray JJ. More 'malignant' than cancer? Five-year survival following a first admission for heart failure. Eur J Heart Fail. 2001 Jun;3(3):315-22. doi: 10.1016/s1388-9842(00)00141-0.
- Background: PubMed 20923990Stewart S, Ekman I, Ekman T, Oden A, Rosengren A. Population impact of heart failure and the most common forms of cancer: a study of 1 162 309 hospital cases in Sweden (1988 to 2004). Circ Cardiovasc Qual Outcomes. 2010 Nov;3(6):573-80. doi: 10.1161/CIRCOUTCOMES.110.957571. Epub 2010 Oct 5.
- Background: PubMed 19153268Jhund PS, Macintyre K, Simpson CR, Lewsey JD, Stewart S, Redpath A, Chalmers JW, Capewell S, McMurray JJ. Long-term trends in first hospitalization for heart failure and subsequent survival between 1986 and 2003: a population study of 5.1 million people. Circulation. 2009 Feb 3;119(4):515-23. doi: 10.1161/CIRCULATIONAHA.108.812172. Epub 2009 Jan 19.
- Background: PubMed 18799522Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. No abstract available.
- Background: PubMed 22034480Bristow MR. Treatment of chronic heart failure with beta-adrenergic receptor antagonists: a convergence of receptor pharmacology and clinical cardiology. Circ Res. 2011 Oct 28;109(10):1176-94. doi: 10.1161/CIRCRESAHA.111.245092.
- Background: PubMed 10023943The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet. 1999 Jan 2;353(9146):9-13.
- Background: PubMed 10376614Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999 Jun 12;353(9169):2001-7.
- Background: PubMed 10714728Hjalmarson A, Goldstein S, Fagerberg B, Wedel H, Waagstein F, Kjekshus J, Wikstrand J, El Allaf D, Vitovec J, Aldershvile J, Halinen M, Dietz R, Neuhaus KL, Janosi A, Thorgeirsson G, Dunselman PH, Gullestad L, Kuch J, Herlitz J, Rickenbacher P, Ball S, Gottlieb S, Deedwania P. Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: the Metoprolol CR/XL Randomized Intervention Trial in congestive heart failure (MERIT-HF). MERIT-HF Study Group. JAMA. 2000 Mar 8;283(10):1295-302. doi: 10.1001/jama.283.10.1295.
- Background: PubMed 12390947Packer M, Fowler MB, Roecker EB, Coats AJ, Katus HA, Krum H, Mohacsi P, Rouleau JL, Tendera M, Staiger C, Holcslaw TL, Amann-Zalan I, DeMets DL; Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) Study Group. Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the carvedilol prospective randomized cumulative survival (COPERNICUS) study. Circulation. 2002 Oct 22;106(17):2194-9. doi: 10.1161/01.cir.0000035653.72855.bf.
- Background: PubMed 25912106Pasternak B, Mattsson A, Svanstrom H, Hviid A. Comparative effectiveness of bisoprolol and metoprolol succinate in patients with heart failure. Int J Cardiol. 2015;190:4-6. doi: 10.1016/j.ijcard.2015.03.441. Epub 2015 Apr 18. No abstract available.
- 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.
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 Heart Failure With Reduced Ejection Fraction, run by University Hospital, Caen at 1 site in France.
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 4 inclusion and 8 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 23 Aug 2018. 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bisoprolol residual plasma concentration by dose and renal function (time frame: At the time of inclusion). 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 NCT03644446, which also lists 28 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 23 Aug 2018.