Evaluating the Effect of Spironolactone on Hypertrophic Cardiomyopathy

NCT02948998 | Unknown Phase 4 DMC

• 1 other identifier: XH-16-032
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertrophic Cardiomyopathy; Fibrosis

Outcome Measures

Primary Outcomes (1)

• the extent of late gadolinium enhancement (LGE+%)

  LGE-CMR will be used to measure the extent of LV fibrosis in the participants. 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).

  2 years

Study Arms (2)

control

NO INTERVENTION

The participants in control group do not take spironolactone.

spironolactone

EXPERIMENTAL

The participants in spironolactone group take 10-20mg spironolactone orally and daily.

Drug: Spironolactone

Interventions

Spironolactone 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.

Also known as: LuoNeiZhi

spironolactone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Ruijin Hospital: collaborator
• RenJi Hospital: collaborator
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicne

Shanghai, Shanghai Municipality, 200092, China

Location

Related Publications (48)

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MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Fibrosis

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yi-Gang Li, MD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medcine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beiqing Jiang, MD

CONTACT

25078999; xinhuakeyan@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: October 31, 2016
• Study Start: May 14, 2018
• Primary Completion: October 1, 2019
• Study Completion: July 1, 2020
• Last Updated: May 9, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)