A study to evaluate the efficacy and safety of LCZ969 in heart failure patients with preserved ejection fraction.

Phase 1

• Conditions: Heart failure with preserved ejection fraction; MedDRA version: 20.1 Level: LLT Classification code 10069211 Term: Diastolic heart failure System Organ Class: 100000004849; MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001747-31-PL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-12
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 4600

Inclusion Criteria

- Left ventricular ejection fraction (LVEF) =45% prior to study entry.
- Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF =30 days prior to study entry.
- Current symptom(s) of HF.
- Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by
echocardiogram.
- At least one of the following: a HF hospitalization within 9 months prior to study entry and/or an elevated NT-proBNP.
- 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 990
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3310

Exclusion Criteria

- Any prior echocardiographic measurement of LVEF < 40%.
- Acute coronary syndrome (including myocardial infarction (MI)),
cardiac surgery, other major cardiovascular surgery within 3 months, or
urgent percutaneous coronary intervention (PCI) within 30 days of
entry.
- Any clinical event within 6 months 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 =
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.
- Other protocol-defined exclusion criteria may apply.

Study & Design

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