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

NCT ID: NCT05089539

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-04-01

Brief Summary

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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).

Detailed Description

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Heart failure with preserved ejection fraction (HFpEF) comprises approximately 50% of all heart failure. The effectively therapeutic approaches for 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). We will randomly assign 60 patients with HFpEF (NYHA II-IV) class, ejection fraction ≥ 50% and elevated level of natriuretic peptides to receive sacubitril-valsartan (target 100mg bid) or placebo (100mg bid). The primary endpoint is change in extracellular volume \[ECV\] measured by CMR. The secondary endpoints were 6-minute walking distance(6-WMD), KCCQ, hospitalizations for heart failure, myocardial infarction and death.

Conditions

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Heart Failure With Preserved Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HFpEF with ARNI treatment

Sacubitril/valsartan (ARNI, 100mg bid)

Group Type EXPERIMENTAL

Angiotensin Receptor-Neprilysin Inhibition

Intervention Type DRUG

Sacubitril/valsartan \[100 mg\] bid). Continuous treatment was maintained for at least three months.

Control group

placebo (100mg bid)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo \[100 mg\] bid). Continuous treatment was maintained for at least three months.

Interventions

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Angiotensin Receptor-Neprilysin Inhibition

Sacubitril/valsartan \[100 mg\] bid). Continuous treatment was maintained for at least three months.

Intervention Type DRUG

Placebo

Placebo \[100 mg\] bid). Continuous treatment was maintained for at least three months.

Intervention Type DRUG

Other Intervention Names

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Sacubitril/valsartan

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Dongying Zhang

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The first affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status

Countries

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China

References

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Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.

Reference Type BACKGROUND
PMID: 31475794 (View on PubMed)

Vaduganathan M, Jhund PS, Claggett BL, Packer M, Widimsky J, Seferovic P, Rizkala A, Lefkowitz M, Shi V, McMurray JJV, Solomon SD. A putative placebo analysis of the effects of sacubitril/valsartan in heart failure across the full range of ejection fraction. Eur Heart J. 2020 Jul 1;41(25):2356-2362. doi: 10.1093/eurheartj/ehaa184.

Reference Type BACKGROUND
PMID: 32221596 (View on PubMed)

van der Meer P, Gaggin HK, Dec GW. ACC/AHA Versus ESC Guidelines on Heart Failure: JACC Guideline Comparison. J Am Coll Cardiol. 2019 Jun 4;73(21):2756-2768. doi: 10.1016/j.jacc.2019.03.478.

Reference Type BACKGROUND
PMID: 31146820 (View on PubMed)

Other Identifiers

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2021-10-21

Identifier Type: -

Identifier Source: org_study_id