CompletedPhase 2

LCZ696 in Advanced LV Hypertrophy and HFpEF

Russia61 participantsStarted 2019-05-31

Plain-language summary

Patients with advanced LVH and HFpEF will be randomly assigned in open-label fashion to receive LCZ696 titrated to 200 mg twice daily or valsartan titrated to 160 mg twice daily, and will be treated for 24 weeks.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Moderate/severe hypertensive left ventricular (LV) hypertrophy (LVMi ≥109 g/m² in women and ≥132 g/m² in men);
. New York Heart Association (NYHA) class II-III heart failure;
. Left ventricular ejection fraction \> 50%;
. Increased LV filling pressures assessed at rest or at peak exercise by echocardiography
. Body mass index (BMI) \> 30 kg/m²
. Signed and data informed consent

Exclusion criteria

. Age ≤ 18 years;
. Evidence of myocardial ischemia during stress echocardiography;
. Chronic atrial flutter or atrial fibrillation;
. Alternative cause of left ventricular hypertrophy and impaired diastolic function (hypertrophic/restictive cardiomyopathy, aortic stenosis, constrictive pericarditis and etc.);
. NYHA classification I or decompensated heart failure at screening;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in 6-minute walking distance (6MWD)

Timeframe: 24 weeks

Trial details

NCT IDNCT03928158

SponsorNational Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Heart Failure trials