Evaluating the Effect of Spironolactone on Hypertrophic Cardiomyopathy
NCT ID: NCT02948998
Last Updated: 2018-05-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
260 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-05-14
Study Completion Date
2020-07-31
Brief Summary
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Hypertrophic Cardiomyopathy (HCM) is the most common hereditary heart disease with high mortality. Heart failure is the most common complication (about 50% incidence) in these patients. However, it is lack of efficiency medicine to treat heart failure for HCM patients.
Recent studies found fibrosis was common in HCM patients and it was progressive with aging. Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) is a gold standard to measure the left ventricular(LV) fibrosis extent and been proven to be useful in HCM patients.
Aldosterone plays an important role in the development of fibrosis. Meanwhile, a few studies suggested that aldosterone might participate the development of fibrosis in HCM patients. Spironolactone, a mineralocorticoid receptor antagonist, has been proven its effect on inceasing the survival of the heart-failure patients with the eject fraction lower than 35%.
Thus, the investigators hypothesize that fibrosis is one important reason of heart failure for HCM patients. The purpose of this study is to investigate whether small dosage and early prescription of spironolactone to HCM patients can relieve and/or reverse the fibrosis progress and improve patients' symptoms.
This study is a multicenter, randomized, controlled and open-label study being conducted in 4 centers in Shanghai, China. The primary objective of the study is to evaluate the efficacy of spironolactone on relieving the LV fibrosis in HCM patients. This study plans to recruit 260 participants with definite HCM diagnosis. Then these participants will be randomized to two groups-- "control group "(not taking spironolactone) and "spironolactone group" (taking 20mg spironolactone orally and daily). LGE-CMR, echocardiography, 24-hour Holter, electrocardiography (ECG), and blood test (including hemoglobin, creatitine, potassium, liver enzymes, proBNP, TnT, angiotensin and aldosterone) will be performed before random allocation and after 2 years. LGE-CMR will be used to measure the extent of fibrosis in LV. The extent of LGE+% (the area showing LGE divided by the total area) before and after 2-year experiment and the increase of LGE+% after 2-year experiment will be compared between control and spironolactone groups. Meanwhile, symptoms, New York Heart Association classification of cardiac function, arrhythmia, proBNP and TnT etc. will be compared between two groups.
Recent studies found fibrosis was common in HCM patients and it was progressive with aging. Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) is a gold standard to measure the left ventricular(LV) fibrosis extent and been proven to be useful in HCM patients.
Aldosterone plays an important role in the development of fibrosis. Meanwhile, a few studies suggested that aldosterone might participate the development of fibrosis in HCM patients. Spironolactone, a mineralocorticoid receptor antagonist, has been proven its effect on inceasing the survival of the heart-failure patients with the eject fraction lower than 35%.
Thus, the investigators hypothesize that fibrosis is one important reason of heart failure for HCM patients. The purpose of this study is to investigate whether small dosage and early prescription of spironolactone to HCM patients can relieve and/or reverse the fibrosis progress and improve patients' symptoms.
This study is a multicenter, randomized, controlled and open-label study being conducted in 4 centers in Shanghai, China. The primary objective of the study is to evaluate the efficacy of spironolactone on relieving the LV fibrosis in HCM patients. This study plans to recruit 260 participants with definite HCM diagnosis. Then these participants will be randomized to two groups-- "control group "(not taking spironolactone) and "spironolactone group" (taking 20mg spironolactone orally and daily). LGE-CMR, echocardiography, 24-hour Holter, electrocardiography (ECG), and blood test (including hemoglobin, creatitine, potassium, liver enzymes, proBNP, TnT, angiotensin and aldosterone) will be performed before random allocation and after 2 years. LGE-CMR will be used to measure the extent of fibrosis in LV. The extent of LGE+% (the area showing LGE divided by the total area) before and after 2-year experiment and the increase of LGE+% after 2-year experiment will be compared between control and spironolactone groups. Meanwhile, symptoms, New York Heart Association classification of cardiac function, arrhythmia, proBNP and TnT etc. will be compared between two groups.
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Detailed Description
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Hypertrophic Cardiomyopathy (HCM) is the most common hereditary heart disease. Approximate 1--2% population of HCM patients die every year because of cardiocerebrovascular complications in which heart failure, stroke and sudden cardiac deaths rank the top three. Among them, heart failure has the highest incidence (about 50%) but the least ways to treat. Even though the Heart Association of United States and Europe updated the guidelines for the diagnosis and management of HCM, it is still lack of qualified clinical trials about medicine for HCM in the real world.
Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) is a gold standard to measure the left ventricular(LV) fibrosis extent. Recent studies found that: (1)a proportion of HCM patients have LV fibrosis during the early stage of disease; (2)the LV fibrosis in the HCM patients is progressive; (3)about 91.5% population of HCM patients had late gadolinium enhancement; and(4) late gadolinium enchancement in the HCM patients is related to the risk of sudden death.
Fibrosis is an important pathology of heart failure for the patients with coronary artery disease and dilated cardiomyopathy. The activation of renin-angiotensin-aldosterone system plays a key role during the progression of heart failure. Small dosage of spironolactone has been proven its effect on inceasing the survival of the heart-failure patients with the eject fraction lower than 35%. Meanwhile, a few studies found aldosterone levels of LV myocytes increased both in HCM patients and HCM transgenic mice. Furthermore, spironolactone, a mineralocorticoid receptor antagonist, could reserve interstitial fibrosis, attenuate myocyte disarray by 50%, and improve diastolic function in HCM transgenic mice.
Thus, the investigators hypothesize that fibrosis is one important reason of heart failure for HCM patients and small dosage and early prescription of spironolactone to HCM patients can relieve and/or reverse the fibrosis progress and improve patients' symptoms.
This study is a multicenter, randomized, controlled and open-label study being conducted in 4 centers in Shanghai, China. The primary objective of the study is to evaluate the efficacy of spironolactone on relieving the LV fibrosis in HCM patients.
This study plans to recruit 260 participants with definite HCM diagnosis. Then these participants will be randomized to two groups-- "control group "(not taking spironolactone) and "spironolactone group" (taking 20mg spironolactone orally and daily). LGE-CMR, echocardiography, 24-hour Holter, electrocardiography (ECG), and blood test (including hemoglobin, creatitine, potassium, liver enzymes, proBNP, TnT, angiotensin and aldosterone) will be performed before random allocation and after 2 years.
LGE-CMR will be used to measure the extent of fibrosis in LV. Myocardial areas showing signal intensity \>5 SD than mean signal intensity of normal myocardium were defined as segments with LGE. LGE extent in each segment was expressed as the surface area showing LGE divided by the total area of the given myocardial segment, and then summation of the planimetered LGE areas in all short-axis slices yielded total LGE extent, which was subsequently expressed as a proportion of total LV myocardium (LGE+%).
The extent of LGE+% before and after 2-year experiment and the increase of LGE+% after 2-year experiment will be compared between control and spironolactone groups. Meanwhile, symptoms, New York Heart Association classification of cardiac function, arrhythmia, proBNP and TnT etc. will be compared between two groups.
Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) is a gold standard to measure the left ventricular(LV) fibrosis extent. Recent studies found that: (1)a proportion of HCM patients have LV fibrosis during the early stage of disease; (2)the LV fibrosis in the HCM patients is progressive; (3)about 91.5% population of HCM patients had late gadolinium enhancement; and(4) late gadolinium enchancement in the HCM patients is related to the risk of sudden death.
Fibrosis is an important pathology of heart failure for the patients with coronary artery disease and dilated cardiomyopathy. The activation of renin-angiotensin-aldosterone system plays a key role during the progression of heart failure. Small dosage of spironolactone has been proven its effect on inceasing the survival of the heart-failure patients with the eject fraction lower than 35%. Meanwhile, a few studies found aldosterone levels of LV myocytes increased both in HCM patients and HCM transgenic mice. Furthermore, spironolactone, a mineralocorticoid receptor antagonist, could reserve interstitial fibrosis, attenuate myocyte disarray by 50%, and improve diastolic function in HCM transgenic mice.
Thus, the investigators hypothesize that fibrosis is one important reason of heart failure for HCM patients and small dosage and early prescription of spironolactone to HCM patients can relieve and/or reverse the fibrosis progress and improve patients' symptoms.
This study is a multicenter, randomized, controlled and open-label study being conducted in 4 centers in Shanghai, China. The primary objective of the study is to evaluate the efficacy of spironolactone on relieving the LV fibrosis in HCM patients.
This study plans to recruit 260 participants with definite HCM diagnosis. Then these participants will be randomized to two groups-- "control group "(not taking spironolactone) and "spironolactone group" (taking 20mg spironolactone orally and daily). LGE-CMR, echocardiography, 24-hour Holter, electrocardiography (ECG), and blood test (including hemoglobin, creatitine, potassium, liver enzymes, proBNP, TnT, angiotensin and aldosterone) will be performed before random allocation and after 2 years.
LGE-CMR will be used to measure the extent of fibrosis in LV. Myocardial areas showing signal intensity \>5 SD than mean signal intensity of normal myocardium were defined as segments with LGE. LGE extent in each segment was expressed as the surface area showing LGE divided by the total area of the given myocardial segment, and then summation of the planimetered LGE areas in all short-axis slices yielded total LGE extent, which was subsequently expressed as a proportion of total LV myocardium (LGE+%).
The extent of LGE+% before and after 2-year experiment and the increase of LGE+% after 2-year experiment will be compared between control and spironolactone groups. Meanwhile, symptoms, New York Heart Association classification of cardiac function, arrhythmia, proBNP and TnT etc. will be compared between two groups.
Conditions
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Hypertrophic Cardiomyopathy
Fibrosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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control
The participants in control group do not take spironolactone.
Group Type
NO_INTERVENTION
No interventions assigned to this group
spironolactone
The participants in spironolactone group take 10-20mg spironolactone orally and daily.
Group Type
EXPERIMENTAL
Spironolactone
Intervention Type
DRUG
The participants in this arm will be prescribed to take 20mg spironolactone orally and daily. Serum potassium concentration and creatinine and blood pressure will be monitored regularly to make the participants safe.
Interventions
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Spironolactone
The participants in this arm will be prescribed to take 20mg spironolactone orally and daily. Serum potassium concentration and creatinine and blood pressure will be monitored regularly to make the participants safe.
Intervention Type
DRUG
Other Intervention Names
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LuoNeiZhi
Eligibility Criteria
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Inclusion Criteria
* male or female, aged from 18 to 75 years
* a wall thickness ≥15mm in one or more LV myocardial segments -- as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging (CMR) or computed tomography (CT) --that is not explained solely by loading conditions
* LVEF≥50%
* serum potassium \<5.0mmol/L
* systolic blood pressure ≥100mmHg
* not taking spironolactone for the last 6 months
* willing to comply with scheduled visits
* informed consent form signed by the subject before participation in the trial
* a wall thickness ≥15mm in one or more LV myocardial segments -- as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging (CMR) or computed tomography (CT) --that is not explained solely by loading conditions
* LVEF≥50%
* serum potassium \<5.0mmol/L
* systolic blood pressure ≥100mmHg
* not taking spironolactone for the last 6 months
* willing to comply with scheduled visits
* informed consent form signed by the subject before participation in the trial
Exclusion Criteria
* cardiac magnetic resonance imaging (CMR) can not be accepted
* spironolactone is not tolerant or is contradicted
* taking spironolactone during the last 6 months
* severe systemic illness with life expectancy judged \< 3 years
* expected to have ventricular septal myectomy or septal alcohol ablation during the trial
* expected to have valve repair or replacement during the trial
* history of myocardial infarction
* angiotension-converting-enzyme inhibitor (ACE-I) or AT-1 receptor blockade is obligatory because of any reason
* systolic blood pressure \<90mmHg
* known orthostatic hypotension
* history of hyperkalemia (serum potassium ≥5.5mmol/L) in the past 6 months or serum potassium ≥5.0mmol/L within the past 2 weeks
* severe renal dysfunction, defined as an eGFR \<30mL/min or serum creatinine ≥221mmol/L
* hemodialysis
* known chronic hepatic disease, defined as aspartate aminotransferase and alanine aminotransferase levels \> 3 times the upper limit of normal as read at the local laboratory
* women of child-bearing or lactation
* cancer
* spironolactone is not tolerant or is contradicted
* taking spironolactone during the last 6 months
* severe systemic illness with life expectancy judged \< 3 years
* expected to have ventricular septal myectomy or septal alcohol ablation during the trial
* expected to have valve repair or replacement during the trial
* history of myocardial infarction
* angiotension-converting-enzyme inhibitor (ACE-I) or AT-1 receptor blockade is obligatory because of any reason
* systolic blood pressure \<90mmHg
* known orthostatic hypotension
* history of hyperkalemia (serum potassium ≥5.5mmol/L) in the past 6 months or serum potassium ≥5.0mmol/L within the past 2 weeks
* severe renal dysfunction, defined as an eGFR \<30mL/min or serum creatinine ≥221mmol/L
* hemodialysis
* known chronic hepatic disease, defined as aspartate aminotransferase and alanine aminotransferase levels \> 3 times the upper limit of normal as read at the local laboratory
* women of child-bearing or lactation
* cancer
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ruijin Hospital
OTHER
Sponsor Role
collaborator
RenJi Hospital
OTHER
Sponsor Role
collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
OTHER
Sponsor Role
collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Yi-Gang Li, MD
Role: PRINCIPAL_INVESTIGATOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medcine
Locations
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicne
Shanghai, Shanghai Municipality, China
Site Status
Countries
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China
Central Contacts
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References
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Ammirati E, Contri R, Coppini R, Cecchi F, Frigerio M, Olivotto I. Pharmacological treatment of hypertrophic cardiomyopathy: current practice and novel perspectives. Eur J Heart Fail. 2016 Sep;18(9):1106-18. doi: 10.1002/ejhf.541. Epub 2016 Apr 24.
Reference Type
BACKGROUND
Semsarian C, Ingles J, Maron MS, Maron BJ. New perspectives on the prevalence of hypertrophic cardiomyopathy. J Am Coll Cardiol. 2015 Mar 31;65(12):1249-1254. doi: 10.1016/j.jacc.2015.01.019.
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Maron BJ, Maron MS. The 20 advances that have defined contemporary hypertrophic cardiomyopathy. Trends Cardiovasc Med. 2015 Jan;25(1):54-64. doi: 10.1016/j.tcm.2014.09.004.
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Ho CY, Lakdawala NK, Cirino AL, Lipshultz SE, Sparks E, Abbasi SA, Kwong RY, Antman EM, Semsarian C, Gonzalez A, Lopez B, Diez J, Orav EJ, Colan SD, Seidman CE. Diltiazem treatment for pre-clinical hypertrophic cardiomyopathy sarcomere mutation carriers: a pilot randomized trial to modify disease expression. JACC Heart Fail. 2015 Feb;3(2):180-8. doi: 10.1016/j.jchf.2014.08.003. Epub 2014 Oct 31.
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Choi HM, Kim KH, Lee JM, Yoon YE, Lee SP, Park EA, Lee W, Kim YJ, Cho GY, Sohn DW, Kim HK. Myocardial fibrosis progression on cardiac magnetic resonance in hypertrophic cardiomyopathy. Heart. 2015 Jun;101(11):870-6. doi: 10.1136/heartjnl-2014-306555. Epub 2015 Apr 20.
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Briasoulis A, Mallikethi-Reddy S, Palla M, Alesh I, Afonso L. Myocardial fibrosis on cardiac magnetic resonance and cardiac outcomes in hypertrophic cardiomyopathy: a meta-analysis. Heart. 2015 Sep;101(17):1406-11. doi: 10.1136/heartjnl-2015-307682. Epub 2015 Jun 9.
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Maron MS, Rowin EJ, Lin D, Appelbaum E, Chan RH, Gibson CM, Lesser JR, Lindberg J, Haas TS, Udelson JE, Manning WJ, Maron BJ. Prevalence and clinical profile of myocardial crypts in hypertrophic cardiomyopathy. Circ Cardiovasc Imaging. 2012 Jul;5(4):441-7. doi: 10.1161/CIRCIMAGING.112.972760. Epub 2012 May 4.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
XH-16-032
Identifier Type: -
Identifier Source: org_study_id
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