NCT03928158

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_2 heart-failure

Timeline
Completed

Started May 2019

Longer than P75 for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 25, 2025

Status Verified

December 1, 2024

Enrollment Period

4.1 years

First QC Date

April 23, 2019

Last Update Submit

May 21, 2025

Conditions

Heart FailureEssential Hypertension

Keywords

left ventricular hypertrophydiastolic dysfunctionLCZ696HFpEFHFLV filling pressures

Outcome Measures

Primary Outcomes (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

    24 weeks

Secondary Outcomes (16)

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

    24 weeks

  • Change in left atrial volume index (LAVI)

    24 weeks

  • Change in average E/e' ratio

    24 weeks

  • Change estimated pulmonary artery systolic pressure (PASP)

    24 weeks

  • Change in left ventricular mass index (LVMI)

    24 weeks

  • +11 more secondary outcomes

Study Arms (2)

LCZ 696

EXPERIMENTAL

Initial 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)

Drug: LCZ 696

Valsatran

ACTIVE COMPARATOR

Initial 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)

Drug: Valsartan

Interventions

LCZ 696DRUG

50-100-200 mg tablet

LCZ 696
ValsartanDRUG

40-80-160 mg tablet

Valsatran

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Medical Research Center for Cardiology

Moscow, 121552, Russia

Location

MeSH Terms

Conditions

Heart FailureEssential HypertensionHypertrophy, Left Ventricular

Interventions

sacubitril and valsartan sodium hydrate drug combinationValsartan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHypertensionVascular DiseasesCardiomegalyHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, MD

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 26, 2019

Study Start

May 31, 2019

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

May 25, 2025

Record last verified: 2024-12

Locations

RU(1)