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Study of stopping heart failure medications in patients with non-ischemic cardiomyopathy who responded very well to cardiac resynchronization therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying non-ischemic cardiomyopathy, which is a type of heart muscle disease that weakens the heart and affects its ability to pump blood effectively, but is not caused by blocked arteries. The study will examine whether patients who have responded very well to a special type of heart device called cardiac resynchronization therapy can safely stop taking some of their heart medications. The medications that may be withdrawn include various blood pressure and heart failure drugs such as captopril, enalapril, lisinopril, ramipril, perindopril, candesartan, losartan, valsartan, telmisartan, sacubitril, bisoprolol, metoprolol, carvedilol, nebivolol, atenolol, propranolol, spironolactone, dapagliflozin, empagliflozin, hydrochlorothiazide, altizide, chlortalidone, and cinnarizine. The purpose of the study is to demonstrate that stopping neurohormonal treatment is not worse than continuing it in terms of the return of heart dysfunction or heart failure symptoms in patients who have had excellent results with their cardiac resynchronization device.

Participants in this study will be patients who have a cardiac resynchronization device implanted in their heart, which helps coordinate the heart's pumping action. These patients must have shown exceptional improvement with this device, having a heart pumping function that has recovered to normal levels and no signs of scarring on special heart imaging tests. They must also have had genetic testing that did not show any inherited heart disease genes. The study will compare two groups: one group will gradually stop taking their heart medications under medical supervision, while the other group will continue taking their medications as usual.

During the study, patients will be monitored for nine months with regular check-ups that include heart function tests using ultrasound, blood tests to measure heart stress markers, quality of life assessments, and device checks to monitor heart rhythm. The main focus will be on whether stopping the medications leads to a worsening of heart function or return of heart failure symptoms within six months. Additional monitoring will continue for twelve months to track emergency visits, hospital admissions, heart rhythm problems, and overall well-being. The study will use various imaging techniques and blood tests to carefully assess heart function throughout the treatment period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and baseline evaluation
At the start of the study, a comprehensive evaluation will be performed to establish baseline measurements.
An echocardiogram (an ultrasound of the heart) will be conducted to measure the heart's pumping function and chamber sizes. This test will confirm that the left ventricular ejection fraction (the percentage of blood pumped out with each heartbeat) is at least 50% and that the heart chamber volumes are normal.
A blood test will be performed to measure NT-proBNP levels, which is a marker that indicates how well the heart is functioning.
The current heart failure symptoms will be assessed using the NYHA class system, which categorizes symptoms from class I (no symptoms) to class IV (severe symptoms).
A quality of life questionnaire will be completed to evaluate overall well-being.
The heart rhythm device will be checked to ensure it is pacing the heart more than 95% of the time.
Step 2
Randomization and treatment assignment
After the baseline evaluation, assignment to one of two groups will occur randomly.
One group will continue taking the current heart medications (the medications listed may include combinations of drugs such as eplerenone, captopril, candesartan, spironolactone, carvedilol, irbesartan, valsartan and sacubitril, dapagliflozin, valsartan, lisinopril, losartan, bisoprolol, propranolol, metoprolol, atenolol, enalapril, empagliflozin, telmisartan, ramipril, or nebivolol). All these medications are taken by mouth.
The other group will gradually stop taking the heart medications under medical supervision.
The specific dosages and frequency of medications will remain as prescribed before entering the study for those continuing treatment.
Step 3
Ongoing monitoring during the first six months
Regular monitoring will occur throughout the first six months of the study.
The heart rhythm device will be checked periodically to ensure proper functioning and to detect any irregular heart rhythms.
Any symptoms of heart failure will be monitored, including shortness of breath, fatigue, or swelling.
If symptoms develop or worsen, additional evaluations may be performed.
Step 4
Six-month evaluation
At six months, a comprehensive evaluation will be performed similar to the initial assessment.
An echocardiogram will be conducted to measure the heart's pumping function and check for any changes in the left ventricular ejection fraction or increases in heart chamber size.
A blood test will measure NT-proBNP levels.
Heart failure symptoms will be assessed using the NYHA class system.
A quality of life questionnaire will be completed.
Any emergency visits, hospital admissions for heart failure, or irregular heart rhythms that occurred during the first six months will be recorded.
The primary assessment will determine if there has been any recurrence of heart dysfunction, defined as a decrease in pumping function of more than 10% with the ejection fraction dropping below 50%, or an increase in heart chamber size of more than 15%, or new heart failure symptoms requiring treatment with water pills (diuretics).
Step 5
Continued monitoring from six to twelve months
Monitoring will continue for an additional six months after the six-month evaluation.
The heart rhythm device will continue to be checked regularly.
Any symptoms, emergency visits, hospital admissions, or irregular heart rhythms will be tracked.
Step 6
Twelve-month final evaluation
At twelve months, a final comprehensive evaluation will be performed.
An echocardiogram will be conducted to measure heart function.
A blood test will measure NT-proBNP levels.
Heart failure symptoms will be assessed using the NYHA class system.
A quality of life questionnaire will be completed.
All emergency visits, hospital admissions for heart failure, and irregular heart rhythms that occurred throughout the entire twelve-month period will be recorded.
A final assessment will determine if there has been any recurrence of heart dysfunction using the same criteria as at six months.

Who can join the trial?

12 criteria

You must be older than 18 years of age
You must have NYHA Class I or II, which means you have no symptoms or only mild symptoms during physical activity
Your NT-proBNP level must be less than 450 ng/L (or less than 1000 ng/L if you have atrial fibrillation or atrial flutter). NT-proBNP is a blood test that measures a substance released when the heart is under stress. Atrial fibrillation and atrial flutter are irregular heart rhythms
You must be taking at least two medications for heart treatment called neurohormonal treatment, which are medicines that help your heart work better
You must have been diagnosed with non-ischemic cardiomyopathy, which is a heart muscle disease not caused by blocked arteries
You must have had a genetic test that came back negative, meaning at least 50 genes were checked and no genetic cause for your heart condition was found
You must have had a cardiac magnetic resonance imaging scan showing no evidence of late gadolinium enhancement, which means no scarring in your heart muscle. Some enhancement at the insertion points of the right heart chamber is acceptable
You must have a resynchronization device implanted, which is a special pacemaker or defibrillator that helps both sides of your heart beat together. The device must be working more than 95% of the time and your QRS (the electrical signal in your heart) must be less than 140ms when the device is working
The reason you received the resynchronization device must have been because your LVEF (a measure of how well your heart pumps blood) was 35% or lower and you had LBBB (a delay in your heart's electrical system) with QRS greater than 150ms
Your current LVEF must be 50% or higher and your left heart chamber size must be normal on an echocardiogram (an ultrasound of your heart) done at least 6 months after your device was implanted
You must not have had any episodes of worsening heart failure requiring hospital admission, emergency room visits, or day hospital visits since your resynchronization device was implanted
You must not need loop diuretic treatment, which are water pills that help remove excess fluid from your body

Who cannot join the trial?

8 criteria

The specific reasons why patients cannot participate in this study have not been provided in the available information
Generally, you would not be able to join if you do not have non-ischemic cardiomyopathy, which is a type of heart muscle disease not caused by blocked arteries
You would likely not qualify if you have not received cardiac resynchronization therapy, which is a special type of pacemaker treatment that helps both sides of the heart beat together
You would not be eligible if you are not a super-responder, meaning someone whose heart function improved very well with the pacemaker treatment
You would not qualify if you have significant arrhythmia, which means irregular or abnormal heart rhythms
You would not be eligible if you have positive genetic testing results that show inherited heart disease
You would not qualify if you still have symptoms of heart failure, such as shortness of breath, swelling, or extreme tiredness
You would not be eligible if your left ventricular function, which is how well the main pumping chamber of your heart works, has not improved or returned to normal

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital De La Santa Creu I Sant Pau
Verified
Barcelona, Spain

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Investigated drugs

Neurohormonal therapy is a type of heart medication that helps control hormones and chemicals in your body that affect how your heart works. These medicines are commonly used to treat heart failure and help your heart pump blood more effectively. In this study, researchers want to see what happens when patients stop taking these medications after their heart condition has improved significantly with a special type of pacemaker treatment.

What is already known about the treatment

Neurohormonal therapy – Neurohormonal therapy refers to a group of medications that are taken by mouth or sometimes given through injection to treat heart failure and weakened heart muscle by blocking harmful hormone signals in the body. These medicines work at the cellular level by stopping substances like adrenaline and other stress hormones from overworking the heart, which helps the heart pump more effectively and prevents further damage to the heart muscle. This treatment approach is widely accepted and commonly used in medical practice for patients with various types of heart problems, particularly those with cardiomyopathy (disease of the heart muscle). The main types of medications in this category include beta-blockers, ACE inhibitors, and drugs that block aldosterone, all of which help reduce symptoms and improve survival in heart failure patients.

Investigated diseases

Non-ischemic cardiomyopathy – Non-ischemic cardiomyopathy is a disease of the heart muscle that is not caused by blocked arteries or reduced blood flow to the heart. In this condition, the heart muscle becomes weakened, enlarged, or structurally abnormal due to various factors such as genetics, infections, toxins, or unknown causes. The weakened heart muscle has difficulty pumping blood effectively throughout the body, leading to reduced heart function. As the disease progresses, the left ventricle, which is the main pumping chamber of the heart, may become enlarged and less efficient. Patients may develop symptoms of heart failure, including shortness of breath, fatigue, and fluid retention in the legs and lungs. The condition can also lead to irregular heart rhythms and changes in the heart's electrical activity.