Study to evaluate the effect of LCZ696 compared to individualized medical therapy for comorbidities in Heart Failure with preserved Ejection Fraction (HFpEF) patients

Phase 1

• Conditions: Heart Failure with preserved Ejection Fraction (HFpEF); MedDRA version: 19.1 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003410-28-ES
• Lead Sponsor: ovartis Farmacética S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-07
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2200

Inclusion Criteria

- Left ventricular ejection fraction (LVEF) =45% by echo within 6 months prior to study entry or during the screening epoch
- Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist [MRAs]) for at least 30 days prior to study entry
- NYHA class II-IV
- Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
- NT-proBNP > 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or >600 pg/mL for patients with AF
- KCCQ clinical summary score < 75
- Patients on ACEi or ARB therapy must have a history of HTN
Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 440
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1760

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 (PCI) within 3 months or an elective PCI within 30 days prior to study entry
- Any clinical event within the 6 months prior to Visit 1 that could have reduced the LVEF (e.g. MI, coronary artery bypass graft [CABG]), unless an echo measurement was performed after the event confirming the LVEF to be = 40% and EF = 45% by the time of screening
- Current acute decompensated HF requiring therapy.
- Current use of renin inhibitor(s)
- History of hypersensitivity to LCZ696 or its components
- Patients with a known history of angioedema
- Walking distance primarily limited by non-cardiac comorbid conditions
- Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dL males and < 9.5 g/dL
females, or body mass index (BMI) > 40 kg/m2.
- Systolic blood pressure (SBP) = 180 mmHg at study entry, or SBP >150 mmHg and <180 mmHg at study entry unless the patient is receiving 3 or more
antihypertensive drugs, or SBP < 110 mmHg at study entry.
- Patients with HbA1c > 7.5% not treated for diabetes
- Patients with prior major organ transplant or intent to transplant (ie on transplant list)
- eGFR < 30 ml/min/1.73 m2 as measured by MDRD at screening
- Serum potassium > 5.2 mmol /L at study entry
- History or presence of any other disease with a life expectancy of < 3 years
- Pregnant or nursing women or women of childbearing potential unless they are using highly effective methods of contraception.
Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified