A RANDOMIZED, DOUBLE-BLIND CONTROLLED STUDY TO EVALUATE THE EFFECT OF LCZ696 COMPARED TO INDIVIDUALIZED MEDICAL THERAPY FOR COMORBIDITIES IN HFPEF PATIENTS

A 24-WEEK, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, PARALLEL GROUP, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFECT OF LCZ696 ON NT-PROBNP, SYMPTOMS, EXERCISE FUNCTION AND SAFETY COMPARED TO INDIVIDUALIZED MEDICAL MANAGEMENT OF COMORBIDITIES IN PATIENTS WITH HEART FAILURE AND PRESERVED EJECTION FRACTION

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-026-17

Enrollment

Registered

2017-10-13

Start date

2017-12-12

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

At the randomization visit (Visit 101), all patients who fulfill the inclusion/exclusion criteria will be stratified based upon prior therapy as described above. Subsequent to stratification,patients

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent. 2. ≥ 45 years of age, male, or female. 3. LVEF ≥ 45% by echocardiography. 4. Symptom(s) of HF requiring treatment with diuretics for at least 30 days prior to V1. 5. Current symptom(s) of HF (NYHA class II-IV) at V1. 6. Structural heart disease demonstrated by echocardiographic evidence of left atrial enlargement (LAE) or left ventricular hypertrophy (LVH). 7. Receiving evidence based therapy for comorbidities as determined by the individual clinical profile of the patient with stable doses for the previous 4 weeks. 8. NT-proBNP > 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or > 600 pg/mL for patients with AF on the Visit 1 ECG. 9. KCCQ clinical summary score < 75 at V1. 10. Patients on ACEi or ARB therapy must have a history of HTN.

Exclusion criteria

Exclusion criteria: 1Echocardiographic of LVEF 7.5% not treated. 13History of dilated cardiomyopathy. 14Right sided HF. 15Pericardial constriction, genetic hypertrophic or infiltrative cardiomyopathy. 16Congenital heart disease. 17Valvular heart disease. 18Stroke, transient ischemic attack, carotid surgery or carotid angioplasty. 19Coronary or carotid artery disease or valvular heart disease. 20Arrhythmia. 21CRT device. 22Organ transplant. 23Surgical or medical condition. 24Surgical or medical condition which might alter the dug pharmacokinetic. 25Hepatic disease. 26eGFR 5.2 mmol/L (mEq/L). 29Life expectancy of < 3 years. 30Non-compliance to medical regimens. 31Drug or alcohol abuse. 32Involved in the execution of this protocol. 33Malignancy of any organ system. 34Prohibited medications. 35Pregnant or nursing (lactating) women. 36Women of child-bearing potential, unless using methods of contraception.

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Estonia, France, Germany, Guatemala, Hungary, India, Ireland, Israel, Italy, Latovia, Latvia, Lithuania, Mexico, Peru, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Thailand, Turkey, United Kindgdom, United States

Contacts

Public ContactJose Martin Ortiz

NOVARTIS BIOSCIENCES PERU S.A.

jose.ortiz@novartis.com2006400

Outcome results