AzTrials
AzTrials

Heart FailurePhase 2NCT03928158

LCZ696 in Advanced LV Hypertrophy and HFpEF

A Phase 2 study testing LCZ 696 and Valsartan in people with Heart Failure and Essential Hypertension, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Heart Failure, Essential Hypertension
What is being tested?
LCZ 696 and Valsartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteRussia
Study dates
31 May 2019to 31 Dec 2023
Phase
Phase 2
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
  • Systolic blood pressure < 110 mmHg or > 180 mmHg;
Show all 17Show fewer
  • Diastolic blood pressure < 40 mmHg or > 100 mmHg;
  • Anemia (Hb < 100 g/l);
  • Significant left sided structural valve disease;
  • Secondary hypertension;
  • Dyspnea due to non-cardiac causes such as pulmonary disease, anemia, severe obesity, primary valvular, or myocardial diseases;
  • Myocardial infarction or myocardial revascularization within the last 3 months of screening;
  • Stroke or TIA within the last 3 months of screening;
  • Autoimmunic and oncological diseases;
  • Impaired renal function, defined as eGFR < 30 ml/min/1.73 m²;
  • Impaired liver function;
  • Potassium concentration >5.2 mmol/L.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • National Medical Research Center for Cardiology

    Moscow, 121552

Other trials in Russia

About this study

Official title: Sacubitril/Valsartan (LCZ696) in Patients With Advanced Hypertensive Left Ventricular Hypertrophy and Heart Failure With Preserved Ejection Fraction: Clinical, Haemodynamic and Neurohumoral Effects (a Phase 2, Randomized, Single-center, Parallel Group Study)

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.

Read the detailed description

Heart failure with preserved ejection fraction (HFpEF) has a significant morbidity and mortality, and therapies that have proven effective in HF with reduced EF have not been shown to improve long-term prognosis in HFpEF. Inhibition of circulating neprilysin could augment deficient NP-receptor GC signaling and therefore be beneficial in HFpEF, as suggested by the decrease in NP following administration of valsartan/sacubitril in the phase 2 (PARAMOUNT study). Use of valsartan/sacubitril is currently being tested in the multicenter PARAGON-HF trial with HFpEF patients. The investigators suppose the best candidates for LCZ696 therapy will be patients with HFpEF and advanced concentric LV hypertrophy and obesity, i.e. having the lowest BNP bioavailability.

Being tested
LCZ 696, Valsartan
Keywords
left ventricular hypertrophy, diastolic dysfunction, LCZ696, HFpEF, HF, LV filling pressures
Medical subject headings
Heart Failure, Essential Hypertension, Hypertrophy, Left Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LCZ 696Drug

    50-100-200 mg tablet

  • ValsartanDrug

    40-80-160 mg tablet

Study groups in NCT03928158
Study groupRoleWhat they receive
LCZ 696ExperimentalInitial dose - 50 mg twice daily, up-titration to 200 mg twice daily. Patients will also receive standard therapy for heart failure (β-blockers, diuretics, MRAs)
Receives: Drug: LCZ 696
ValsatranActive comparatorInitial dose - 40 mg twice daily, up-titration to 160 mg twice daily. Patients also will receive standard therapy for heart failure (β-blockers, diuretics, MRAs)
Receives: Drug: Valsartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 6-minute walking distance (6MWD)

    Difference in distance walked during 6-minute walking test (6MWT) between 24 weeks after baseline and at baseline

    Measured: 24 weeks

Secondary outcomes (16)

  1. Change in exercise time during diastolic stress-test (DST)

    Difference in exercise time during DST between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  2. Change in left atrial volume index (LAVI)

    Difference in LAVI assessed by echocardiography between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  3. Change in average E/e' ratio

    Difference in E/e' ratio assessed by echocardiography both at rest and at peak exercise during diastolic stress test (DST) between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  4. Change estimated pulmonary artery systolic pressure (PASP)

    Difference in PASP assessed by echocardiography at peak exercise both at rest and at peak exercise during diastolic stress test (DST) between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  5. Change in left ventricular mass index (LVMI)

    Difference in LVMI assessed by echocardiography between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  6. Change of New York Heart Association (NYHA) functional classification

    Difference in NYHA class between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  7. Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) score

    Difference in MLHFQ score between 24 weeks after baseline and at baseline. The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses. Score ranges from 0 (best quality of life) to 105 (worst quality of life).

    Measured: 24 weeks

  8. Change in N-terminal pro b-type natriuretic peptide (NT-proBNP)

    Difference in NT-proBNP plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  9. Change in high-sensitivity C-reactive protein (hsCRP)

    Difference in hsCRP plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  10. Change in carboxyterminal propeptide of type I collagen (PICP)

    DIfference in PICP plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  11. Change in carboxyterminal telopeptide of type I collagen (CITP)

    Difference in CITP plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  12. Change in N-Propeptide Of Type III Procollagen (PIIINP)

    Difference in PIIINP plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  13. Change in Growth/differentiation factor 15 (GDF-15)

    Difference in GDF-15 plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  14. Change in sST2

    Difference in sST2 plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  15. Change in Galectin-3

    Difference in Galectin-3 plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  16. Change in monocyte chemoattractant-1 (MCP-1)

    DIfference in MCP-1 plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2019
  2. Study start31 May 2019
  3. Primary completion30 Jun 2023
  4. Study completion31 Dec 2023

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03928158
Sponsor's protocol ID
AAAA-A18-118022290061-2
Status last verified
Dec 2024
First submitted
23 Apr 2019
Last updated
25 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LCZ 696 and Valsartan in people with Heart Failure and Essential Hypertension, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

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 6 inclusion and 17 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: finished, as of the sponsor's last update on 25 May 2025. 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 Russia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in 6-minute walking distance (6MWD) (time frame: 24 weeks). 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 NCT03928158.

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 25 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in