Dilated CardiomyopathyWrecEFNCT02770443
Withdrawal of Medication in Recovered DCM
A study testing withdrawal in people with Dilated Cardiomyopathy, run by McGill University at 1 site in Canada.
Trial summary
Randomized study of medication withdrawal in patients who have recovered LV function in Dilated Cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- withdrawal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 19 Feb 2016to Nov 2019
- Phase
- Interventional
- 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
Who may be able to join
- Patient diagnosed with dilated cardiomyopathy (DCM) with an initial HFrEF < 40 % at presentation.
- DCM with recovered LV function to > or = to 50% documented on 2 ECHO examinations, with the most recent ECHO examination within 1 year of enrolment.
- Time from initial diagnosis of DCM more or equal to 24 month.
- Last hospitalization for decompensated HF > 1year.
Who cannot join
- Ischemic cardiomyopathy
- Other structural pathology such as: Hypertrophic cardiomyopathy, Valvular cardiomyopathy or congenital heart disease.
- Last hospitalization for decompensated HF < 1year ago.
- Previous sustained ventricle tachycardia or ventricle fibrillation (VF) arrest.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Withdrawal of Beta- Blockers and ACE Inhibitors After Left Ventricular Systolic Function Recovery in Patient With Dilated Cardiomyopathy: A Randomized Control Trial.
Randomized study of medication withdrawal in patients who have recovered LV function in Dilated Cardiomyopathy.
Read the detailed description
Importance of the study:
There is a growing population of patients with dilated cardiomyopathy (DCM) who had recovered left ventricular (LV) systolic function on medical therapy. Recent studies have shown a favorable clinical course in patients with DCM1-4. The heart failure (HF) guidelines states that discontinuation of medical therapy in this group of patients may be considered based on expert opinion. The safety of withdrawal of medical therapy needs further studies.
Hypothesis:
In Patients with dilated cardiomyopathy (DCM) who had recovery of the LV systolic function to a normal EF >50%, medical therapy withdrawal is attainable without Clinical deterioration or recurrence of LV systolic dysfunction.
Objective
- To study the withdrawal of guideline directed medical therapy, specifically beta-blockers and ACE/ARB, in patients with DCM after recovery of LV EF.
- Correlate the sustained recovery in LVEF after medication discontinuation with specific genetic markers of recovery.
Method:
Study design:
It is a multi-center, non-blinded, randomized Control trial (pilot) comparing withdrawal of medical therapy in patients with recovered LVEF (recEF) compared to patients continuing medical therapy. Therapeutic changes will occur in a 2:1 randomization at the Royal Victoria Hospital, the Montreal General Hospital and the Jewish General Hospital. Patient would be recruited from a Heart Function Clinic or the echocardiography lab.
Procedures:
Patient Selection:
Patient selection will be conducted through chart review, ECHO lab, as well as the clinical visits. The DPS authorization will be requested.
Informed consent:
At time of enrolment the study's objective, procedures as well as the risks and benefits will be explained to the patient. A consent form will be provided to the patient. In addition, a wallet card and a medication discontinuations chart.
Randomization:
Randomization will be conducted in 2:1 fashion, non-blinded, through a sealed envelop randomization system.
Medical therapy withdrawal:
Medical therapy withdrawal will be conducted in 2 phases.
Phase 1:
This phase involves the withdrawal of the beta-blocker. The patient will be followed for signs of deterioration for a period of 6 months following the withdrawal.
Phase 2:
If there are no signs of deterioration the ACE/ARB inhibitor will be withdrawn as well. The patient will be followed up in 6 month for signs of deterioration. All other medical therapies other than beta-blocker and ACE inhibitors will continue until successful withdrawal of beta-blockers and ACE inhibitor is achieved.
Beta-blocker discontinuation:
The initial tapering off will occur over a 2week period. The beta -blocker will be discontinued by the end of the 2nd week.
For example: Metoprolol 100mg bid to Metoprolol 75mg bid for 5days. Followed by Metoprolol 50mg bid for 4 days, then Metoprolol 25 mg for 3 days and then completely discontinued.
ACE/ARB discontinuation:
The discontinuation of ACE/ARB will be similar to the beta-blockers. The doses will be tapered over a two-week period.
A supplementary chart of dose reduction is provided. The doses included are the standard medication doses.
Digoxin, diuretic, spironolactone will be discontinued if both the beta-blocker and ACE-ARB discontinuation has been well tolerated or if a clinical indication warrants the discontinuation. Up titration of therapies will not be permitted.
Additional therapy for SBP > 130 or DBP >80mmHg with non-ACE or beta blocker therapy will be considered.
Genotyping: Genetic analysis for DCM causing gene will be sent for the study patients. The genotyping is selective, patient will have the option to opt out the genetic analysis if they do not prefer having a genotyping done. All samples will be stored in a bio bank to maximum of 25 years. Two comparisons will be conducted on the genotyping:
- The genetic typing for Patients with improved EF will be compared to the control group from the ongoing DCM cohort at the McGill University Health Center.
- A second comparison between the patients within the withdrawal cohort. A comparison will be made between patients with rebound HF and the patient who did not HF with discontinuation of medical therapy.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- withdrawal, standard of CARE
- Keywords
- Recovered LVEF, DCM
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
withdrawalDrug
Also called withdrawal ACE and beta blockers, discontinuation of ACE and beta blockers
withdrawal of beta blocker and ACE inhibitors
standard of CAREDrug
STANDARD OF CARE, NO WITHDRAWAL OF MEDICAL THERAPY
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Withdrawal of beta blockers and ACE inhibitors Receives: Drug: withdrawal |
| control | Placebo comparator | no withdrawal, standard of care Receives: Drug: standard of CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that become symptomatic
Measured: 1 year
Secondary outcomes (1)
Number of patients that drop EF to <45%
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start19 Feb 2016
- Primary completion24 Aug 2017
- Study completionNov 2019
Why it stopped: Study closed to recruitment early as endpoints were reached on several participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Jewish General Hospital
- Responsible party
- Principal investigator, Nadia Giannetti, McGill University
- Investigators
- Nadia Giannetti, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770443
- Sponsor's protocol ID
- 15-284-MUHC
- Acronym
- WrecEF
- Status last verified
- Jan 2020
- First submitted
- 29 Apr 2016
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gupta A, Goyal P, Bahl A. Frequency of recovery and relapse in patients with nonischemic dilated cardiomyopathy on guideline-directed medical therapy. Am J Cardiol. 2014 Sep 15;114(6):883-9. doi: 10.1016/j.amjcard.2014.06.021. Epub 2014 Jul 2.
PubMed 25084692Moon J, Ko YG, Chung N, Ha JW, Kang SM, Choi EY, Rim SJ. Recovery and recurrence of left ventricular systolic dysfunction in patients with idiopathic dilated cardiomyopathy. Can J Cardiol. 2009 May;25(5):e147-50. doi: 10.1016/s0828-282x(09)70497-0.
PubMed 19417864Zhang Y, Guallar E, Blasco-Colmenares E, Butcher B, Norgard S, Nauffal V, Marine JE, Eldadah Z, Dickfeld T, Ellenbogen KA, Tomaselli GF, Cheng A. Changes in Follow-Up Left Ventricular Ejection Fraction Associated With Outcomes in Primary Prevention Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Recipients. J Am Coll Cardiol. 2015 Aug 4;66(5):524-31. doi: 10.1016/j.jacc.2015.05.057.
PubMed 26227190Blechman I, Arad M, Nussbaum T, Goldenberg I, Freimark D. Predictors and outcome of sustained improvement in left ventricular function in dilated cardiomyopathy. Clin Cardiol. 2014 Nov;37(11):687-92. doi: 10.1002/clc.22331. Epub 2014 Sep 18.
PubMed 25236761Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.
PubMed 23747642Basuray A, French B, Ky B, Vorovich E, Olt C, Sweitzer NK, Cappola TP, Fang JC. Heart failure with recovered ejection fraction: clinical description, biomarkers, and outcomes. Circulation. 2014 Jun 10;129(23):2380-7. doi: 10.1161/CIRCULATIONAHA.113.006855. Epub 2014 May 5.
PubMed 24799515Amos AM, Jaber WA, Russell SD. Improved outcomes in peripartum cardiomyopathy with contemporary. Am Heart J. 2006 Sep;152(3):509-13. doi: 10.1016/j.ahj.2006.02.008.
PubMed 16923422Waagstein F, Caidahl K, Wallentin I, Bergh CH, Hjalmarson A. Long-term beta-blockade in dilated cardiomyopathy. Effects of short- and long-term metoprolol treatment followed by withdrawal and readministration of metoprolol. Circulation. 1989 Sep;80(3):551-63. doi: 10.1161/01.cir.80.3.551.
PubMed 2548768Morimoto S, Shimizu K, Yamada K, Hiramitsu S, Hishida H. Can beta-blocker therapy be withdrawn from patients with dilated cardiomyopathy? Am Heart J. 1999 Sep;138(3 Pt 1):456-9. doi: 10.1016/s0002-8703(99)70147-x.
PubMed 10467195Hopper I, Samuel R, Hayward C, Tonkin A, Krum H. Can medications be safely withdrawn in patients with stable chronic heart failure? systematic review and meta-analysis. J Card Fail. 2014 Jul;20(7):522-32. doi: 10.1016/j.cardfail.2014.04.013. Epub 2014 Apr 18.
PubMed 24747201Pflugfelder PW, Baird MG, Tonkon MJ, DiBianco R, Pitt B. Clinical consequences of angiotensin-converting enzyme inhibitor withdrawal in chronic heart failure: a double-blind, placebo-controlled study of quinapril. The Quinapril Heart Failure Trial Investigators. J Am Coll Cardiol. 1993 Nov 15;22(6):1557-63. doi: 10.1016/0735-1097(93)90578-o.
PubMed 8227822Nicholls MG, Ikram H, Espiner EA, Maslowski AH, Scandrett MS, Penman T. Hemodynamic and hormonal responses during captopril therapy for heart failure: acute, chronic and withdrawal studies. Am J Cardiol. 1982 Apr 21;49(6):1497-501. doi: 10.1016/0002-9149(82)90367-8.
PubMed 6803564Konstam MA, Rousseau MF, Kronenberg MW, Udelson JE, Melin J, Stewart D, Dolan N, Edens TR, Ahn S, Kinan D, et al. Effects of the angiotensin converting enzyme inhibitor enalapril on the long-term progression of left ventricular dysfunction in patients with heart failure. SOLVD Investigators. Circulation. 1992 Aug;86(2):431-8. doi: 10.1161/01.cir.86.2.431.
PubMed 1638712Shammas NW, Harris ML, McKinney D, Hauber WJ. Digoxin withdrawal in patients with dilated cardiomyopathy following normalization of ejection fraction with beta blockers. Clin Cardiol. 2001 Dec;24(12):786-7. doi: 10.1002/clc.4960241207.
PubMed 11768743Khand AU, Rankin AC, Martin W, Taylor J, Gemmell I, Cleland JG. Carvedilol alone or in combination with digoxin for the management of atrial fibrillation in patients with heart failure? J Am Coll Cardiol. 2003 Dec 3;42(11):1944-51. doi: 10.1016/j.jacc.2003.07.020.
PubMed 14662257
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Withdrawal of Beta- Blockers and ACE Inhibitors After Left Ventricular Systolic Function Recovery in Patient With Dilated Cardiomyopathy: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT02770443
- Acronym / sponsor ID
- WrecEF / 15-284-MUHC
- Conditions
- Dilated Cardiomyopathy
- Keywords
- Recovered LVEF, DCM
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed to recruitment early as endpoints were reached on several participants
- Enrolment
- 22 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Jewish General Hospital
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 12 May 2016 (estimated)
- 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.
Randomized study of medication withdrawal in patients who have recovered LV function in Dilated Cardiomyopathy.
Detailed description
Importance of the study:
There is a growing population of patients with dilated cardiomyopathy (DCM) who had recovered left ventricular (LV) systolic function on medical therapy. Recent studies have shown a favorable clinical course in patients with DCM1-4. The heart failure (HF) guidelines states that discontinuation of medical therapy in this group of patients may be considered based on expert opinion. The safety of withdrawal of medical therapy needs further studies.
Hypothesis:
In Patients with dilated cardiomyopathy (DCM) who had recovery of the LV systolic function to a normal EF >50%, medical therapy withdrawal is attainable without Clinical deterioration or recurrence of LV systolic dysfunction.
Objective
- To study the withdrawal of guideline directed medical therapy, specifically beta-blockers and ACE/ARB, in patients with DCM after recovery of LV EF.
- Correlate the sustained recovery in LVEF after medication discontinuation with specific genetic markers of recovery.
Method:
Study design:
It is a multi-center, non-blinded, randomized Control trial (pilot) comparing withdrawal of medical therapy in patients with recovered LVEF (recEF) compared to patients continuing medical therapy. Therapeutic changes will occur in a 2:1 randomization at the Royal Victoria Hospital, the Montreal General Hospital and the Jewish General Hospital. Patient would be recruited from a Heart Function Clinic or the echocardiography lab.
Procedures:
Patient Selection:
Patient selection will be conducted through chart review, ECHO lab, as well as the clinical visits. The DPS authorization will be requested.
Informed consent:
At time of enrolment the study's objective, procedures as well as the risks and benefits will be explained to the patient. A consent form will be provided to the patient. In addition, a wallet card and a medication discontinuations chart.
Randomization:
Randomization will be conducted in 2:1 fashion, non-blinded, through a sealed envelop randomization system.
Medical therapy withdrawal:
Medical therapy withdrawal will be conducted in 2 phases.
Phase 1:
This phase involves the withdrawal of the beta-blocker. The patient will be followed for signs of deterioration for a period of 6 months following the withdrawal.
Phase 2:
If there are no signs of deterioration the ACE/ARB inhibitor will be withdrawn as well. The patient will be followed up in 6 month for signs of deterioration. All other medical therapies other than beta-blocker and ACE inhibitors will continue until successful withdrawal of beta-blockers and ACE inhibitor is achieved.
Beta-blocker discontinuation:
The initial tapering off will occur over a 2week period. The beta -blocker will be discontinued by the end of the 2nd week.
For example: Metoprolol 100mg bid to Metoprolol 75mg bid for 5days. Followed by Metoprolol 50mg bid for 4 days, then Metoprolol 25 mg for 3 days and then completely discontinued.
ACE/ARB discontinuation:
The discontinuation of ACE/ARB will be similar to the beta-blockers. The doses will be tapered over a two-week period.
A supplementary chart of dose reduction is provided. The doses included are the standard medication doses.
Digoxin, diuretic, spironolactone will be discontinued if both the beta-blocker and ACE-ARB discontinuation has been well tolerated or if a clinical indication warrants the discontinuation. Up titration of therapies will not be permitted.
Additional therapy for SBP > 130 or DBP >80mmHg with non-ACE or beta blocker therapy will be considered.
Genotyping: Genetic analysis for DCM causing gene will be sent for the study patients. The genotyping is selective, patient will have the option to opt out the genetic analysis if they do not prefer having a genotyping done. All samples will be stored in a bio bank to maximum of 25 years. Two comparisons will be conducted on the genotyping:
- The genetic typing for Patients with improved EF will be compared to the control group from the ongoing DCM cohort at the McGill University Health Center.
- A second comparison between the patients within the withdrawal cohort. A comparison will be made between patients with rebound HF and the patient who did not HF with discontinuation of medical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: withdrawalWithdrawal of beta blockers and ACE inhibitors |
| control | Placebo comparator | Drug: standard of CAREno withdrawal, standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient diagnosed with dilated cardiomyopathy (DCM) with an initial HFrEF < 40 % at presentation.
- DCM with recovered LV function to > or = to 50% documented on 2 ECHO examinations, with the most recent ECHO examination within 1 year of enrolment.
- Time from initial diagnosis of DCM more or equal to 24 month.
- Last hospitalization for decompensated HF > 1year.
Key exclusion criteria (4 listed)
- Ischemic cardiomyopathy
- Other structural pathology such as: Hypertrophic cardiomyopathy, Valvular cardiomyopathy or congenital heart disease.
- Last hospitalization for decompensated HF < 1year ago.
- Previous sustained ventricle tachycardia or ventricle fibrillation (VF) arrest.
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 |
|---|---|---|
| withdrawalAlso: withdrawal ACE and beta blockers, discontinuation of ACE and beta blockerswithdrawal of beta blocker and ACE inhibitors | Drug | Treatment |
| standard of CARESTANDARD OF CARE, NO WITHDRAWAL OF MEDICAL THERAPY | Drug | control |
Primary outcome
Number of patients that become symptomatic
Time frame: 1 year
1 secondary outcome
Number of patients that drop EF to <45%
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Study closed to recruitment early as endpoints were reached on several participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Background: PubMed 25084692Gupta A, Goyal P, Bahl A. Frequency of recovery and relapse in patients with nonischemic dilated cardiomyopathy on guideline-directed medical therapy. Am J Cardiol. 2014 Sep 15;114(6):883-9. doi: 10.1016/j.amjcard.2014.06.021. Epub 2014 Jul 2.
- Background: PubMed 19417864Moon J, Ko YG, Chung N, Ha JW, Kang SM, Choi EY, Rim SJ. Recovery and recurrence of left ventricular systolic dysfunction in patients with idiopathic dilated cardiomyopathy. Can J Cardiol. 2009 May;25(5):e147-50. doi: 10.1016/s0828-282x(09)70497-0.
- Background: PubMed 26227190Zhang Y, Guallar E, Blasco-Colmenares E, Butcher B, Norgard S, Nauffal V, Marine JE, Eldadah Z, Dickfeld T, Ellenbogen KA, Tomaselli GF, Cheng A. Changes in Follow-Up Left Ventricular Ejection Fraction Associated With Outcomes in Primary Prevention Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Recipients. J Am Coll Cardiol. 2015 Aug 4;66(5):524-31. doi: 10.1016/j.jacc.2015.05.057.
- Background: PubMed 25236761Blechman I, Arad M, Nussbaum T, Goldenberg I, Freimark D. Predictors and outcome of sustained improvement in left ventricular function in dilated cardiomyopathy. Clin Cardiol. 2014 Nov;37(11):687-92. doi: 10.1002/clc.22331. Epub 2014 Sep 18.
- Background: PubMed 23747642Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.
- Background: PubMed 24799515Basuray A, French B, Ky B, Vorovich E, Olt C, Sweitzer NK, Cappola TP, Fang JC. Heart failure with recovered ejection fraction: clinical description, biomarkers, and outcomes. Circulation. 2014 Jun 10;129(23):2380-7. doi: 10.1161/CIRCULATIONAHA.113.006855. Epub 2014 May 5.
- Background: PubMed 16923422Amos AM, Jaber WA, Russell SD. Improved outcomes in peripartum cardiomyopathy with contemporary. Am Heart J. 2006 Sep;152(3):509-13. doi: 10.1016/j.ahj.2006.02.008.
- Background: PubMed 2548768Waagstein F, Caidahl K, Wallentin I, Bergh CH, Hjalmarson A. Long-term beta-blockade in dilated cardiomyopathy. Effects of short- and long-term metoprolol treatment followed by withdrawal and readministration of metoprolol. Circulation. 1989 Sep;80(3):551-63. doi: 10.1161/01.cir.80.3.551.
- Background: PubMed 10467195Morimoto S, Shimizu K, Yamada K, Hiramitsu S, Hishida H. Can beta-blocker therapy be withdrawn from patients with dilated cardiomyopathy? Am Heart J. 1999 Sep;138(3 Pt 1):456-9. doi: 10.1016/s0002-8703(99)70147-x.
- Background: PubMed 24747201Hopper I, Samuel R, Hayward C, Tonkin A, Krum H. Can medications be safely withdrawn in patients with stable chronic heart failure? systematic review and meta-analysis. J Card Fail. 2014 Jul;20(7):522-32. doi: 10.1016/j.cardfail.2014.04.013. Epub 2014 Apr 18.
- Background: PubMed 8227822Pflugfelder PW, Baird MG, Tonkon MJ, DiBianco R, Pitt B. Clinical consequences of angiotensin-converting enzyme inhibitor withdrawal in chronic heart failure: a double-blind, placebo-controlled study of quinapril. The Quinapril Heart Failure Trial Investigators. J Am Coll Cardiol. 1993 Nov 15;22(6):1557-63. doi: 10.1016/0735-1097(93)90578-o.
- Background: PubMed 6803564Nicholls MG, Ikram H, Espiner EA, Maslowski AH, Scandrett MS, Penman T. Hemodynamic and hormonal responses during captopril therapy for heart failure: acute, chronic and withdrawal studies. Am J Cardiol. 1982 Apr 21;49(6):1497-501. doi: 10.1016/0002-9149(82)90367-8.
- 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.
Nadia Giannetti, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing withdrawal in people with Dilated Cardiomyopathy, run by McGill University at 1 site in Canada.
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 4 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: stopped early, as of the sponsor's last update on 23 Jan 2020. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Study closed to recruitment early as endpoints were reached on several participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that become symptomatic (time frame: 1 year). 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 NCT02770443, which also lists 18 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 Jan 2020.