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Clinical Trials/EUCTR2016-003410-28-CZ
EUCTR2016-003410-28-CZActive, not recruitingPhase 1

A 24-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate the effect of LCZ696 on NT-proBNP, exercise capacity, symptoms and safety compared to individualized medical management of comorbidities in patients with heart failure and preserved ejection fraction

ovartis Pharma AG0 sites2,500 target enrollmentStarted: May 12, 2017Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
2,500
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •- Left ventricular ejection fraction (LVEF) >40% 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 403
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 2097

Exclusion Criteria

  • •- Any prior measurement of LVEF = 40% under stable conditions
  • •- 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%
  • •- Current (within 30 days from visit 1) acute decompensated HF requiring therapy.
  • •- Current (within 30 days from visit 1) use of renin inhibitor(s), dual RAS blockade or LCZ696
  • •- History of hypersensitivity to LCZ696 or its components
  • •- Patients with a known history of angioedema
  • •- Walking distance primarily limited by non-cardiac comorbid conditions at visit 1
  • •- 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 (or equivalent plasma potassium value) 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.

Investigators

Similar Trials

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EUCTR2016-003410-28-LVovartis Pharma AG2,500