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Clinical Trials List

Protocol NumberCLCZ696D2301
NCT Number(ClinicalTrials.gov Identfier)NCT01920711

2014-11-01 - 2019-05-31

Phase III

Terminated9

ICD-10I50.9

Heart failure, unspecified

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    Novartis Pharmaceuticals

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Kuan-Cheng Chang Division of Cardiovascular Diseases
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳清埤 Division of Cardiovascular Diseases
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 曹玄明 Division of Cardiovascular Diseases
National Yang-Ming University Hospital

Co-Principal Investigator

  • 陳思穎 Division of Cardiovascular Diseases
  • 陳偉華 Division of Cardiovascular Diseases
  • 廖照峰 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chen-Huan Chen Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Zhih-Cherng Chen Division of Cardiovascular Diseases
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Yen-Wen Wu Division of Cardiovascular Diseases
Far Eastern Memorial Hospital

Co-Principal Investigator

  • 林恆旭 Division of Cardiovascular Diseases
  • 邱昱偉 Division of Cardiovascular Diseases
  • 曾炳憲 Division of Cardiovascular Diseases
  • 廖本智 Division of Cardiovascular Diseases
  • 杜宗明 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ju-Yi Chen Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林俊立 Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction

Objectives

The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

Test Drug

LCZ696

Active Ingredient

LCZ696

Dosage Form

tablet

Dosage

50 mg, 100 mg, 200 mg

Endpoints

Primary Outcome Measures :
Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations. [ Time Frame: Total follow up time (up to 57 months) ]
The primary objective of this study is to compare LCZ696 to valsartan in reducing the rate of the composite endpoint of CV death and total (first and recurrent) HF hospitalizations, in HF patients (New York Heart Association [NYHA] Class II-IV) with preserved ejection fraction (left ventricular ejection fraction [LVEF] ≥45%). The treatment arm with the lower rate of events will be deemed as having a successful response.


Secondary Outcome Measures :
Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline, 8 months ]
The KCCQ is a validated instrument for self-assessment of quality of life and health status in heart failure (HF) patients. The clinical summary score, which is derived from the physical limitations and heart failure (HF) symptoms domains of the KCCQ is a valid measure for assessing the patient's health aspects that may be influenced by CV medications. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Evaluation of change from baseline to month 8 in KCCQ a most sensitive, specific, and responsive health-related quality of life measure for heart failure symptoms and physical limitations.

Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class [ Time Frame: Baseline, 8 months ]
Evaluation of change from baseline to Month 8 in NYHA functional class, a well established grading scale used to classify a heart failure's (HF) patients' level of functionality based on the signs and symptoms of HF exhibited by the patient.

Participants With First Occurrence of a Composite Renal Endpoint [ Time Frame: Randomization to total follow-up time (up to 57 months) ]
Analyis of composite renal endpoint defined as renal death, or reaching ESRD, or ≥50% decline in eGFR relative to baseline, using Cox's proportional hazards model.

All-cause Mortality [ Time Frame: Randomization to total follow up time (up to 57 months) ]
Analysis for all-cause mortality using Cox's proportional hazards model.

Inclution Criteria

Inclusion Criteria:

Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or within 6 months prior to study entry.
Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry.
Current symptom(s) of HF (NYHA class II-IV)
Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
Elevated NT-proBNP

Exclusion Criteria

Exclusion Criteria:

Any prior measurement of LVEF < 40%.
Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry.
Any clinical event within the 6 months prior to entry could have reduced the LVEF (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF ≥45%.
Current acute decompensated HF requiring therapy.
Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor.
Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.
Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at entry.
Other protocol-defined inclusion/exclusion criteria may apply.

The Estimated Number of Participants

  • Taiwan

    61 participants

  • Global

    4822 participants

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