The Effect of Angiotensin Receptor-Neprilysin Inhibition on Cardiac Fibrosis in Patients With HFpEF

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The effectively therapeutic approaches for Heart failure with preserved ejection fraction (HFpEF) remain limited. The PARAGON-HF trial found that Angiotensin Receptor-Neprilysin Inhibition (ARNI) has potential benefits for the management of HFpEF. Nevertheless, the role of ARNI in cardiac fibrosis in HFpEF are still unclear. We will conduct a prospective randomized controlled trial to evaluate the effect of ARNI on cardiac fibrosis in patients with HFpEF by cardiac magnetic resonance (CMR).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chongqing Medical University
• Treatments: Valsartan

Criteria

Inclusion Criteria:

• Signed and dated written informed consent

• Age ≥ 45 years at time of screening

• Preserved systolic left ventricular function, defined by left ventricular ejection fraction (LVEF) ≥ 50%

• NYHA classes II-IV

• H2FPEF score ≥ 6 or HFA-PEFF score ≥ 5

Exclusion Criteria:

• Patients with a known history of angioedema

• History of hypersensitivity to ARNI

• Any prior echocardiographic measurement of LVEF <45%

• Significant congenital heart disease

• Rheumatic valvular heart disease

• Acute coronary syndrome, cardiac surgery, other major cardiovascular surgery

• Probable alternative diagnoses could account for the patient's HF symptoms

• Systolic blood pressure(BP) >180 mm Hg or diastolic BP >120 mm Hg at visit

• Diastolic BP <90 mm Hg at visit 1, or symptomatic hypotension

• Patients with a cardiac pacemaker therapy device

• eGFR <30 ml/min/1.73 m2

• Serum potassium >5.2 mmol/l at visit 1

• Pregnant or nursing women