NCT05089539

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

October 21, 2021

Last Update Submit

October 21, 2021

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • Extracellular volume [ECV]

    Extracellular volume \[ECV\] assessment by CMR

    Before ARNI or placebo treatment and after 3 months of continuous ANRI or palcebo treatment

Secondary Outcomes (1)

  • myocardial infarction, hospitalization for heart failure and death

    After 3 months of continuous ANRI or palcebo treatment

Study Arms (2)

HFpEF with ARNI treatment

EXPERIMENTAL

Sacubitril/valsartan (ARNI, 100mg bid)

Drug: Angiotensin Receptor-Neprilysin Inhibition

Control group

PLACEBO COMPARATOR

placebo (100mg bid)

Drug: Placebo

Interventions

Angiotensin Receptor-Neprilysin InhibitionDRUG

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

Also known as: Sacubitril/valsartan
HFpEF with ARNI treatment
PlaceboDRUG

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

Control group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated Hospital of Chongqing Medical University

Chongqing, 400042, China

Location

Related Publications (3)

  • 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.

    PMID: 31475794BACKGROUND

  • 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.

    PMID: 32221596BACKGROUND

  • 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.

    PMID: 31146820BACKGROUND

MeSH Terms

Interventions

sacubitril and valsartan sodium hydrate drug combination

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 21, 2021

First Posted

October 22, 2021

Study Start

November 1, 2021

Primary Completion

February 1, 2022

Study Completion

April 1, 2022

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)