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

Not Applicable

Recruiting

• Conditions: -I50; I50

• Registration Number: PER-026-17
• Lead Sponsor: A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-13
• Study Completion: 2019-10-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 58

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

1Echocardiographic of LVEF < 40%.
2Acute coronary syndrome.
3Event that have reduced the LVEF.
4Acute decompensated HF.
5Renin inhibitor(s).
6Hypersensitivity to LCZ696.
7History of angioedema.
8Walking distance limited by non-cardiac comorbid conditions.
9Alternative diagnoses that could account for HF symptoms.
10Use of investigational drugs.
11Decompensated blood pressure.
12HbA1c > 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 < 30 mL/min/1.73m2.
27Bilateral renal artery stenosis.
28Serum potassium>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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified