NCT04149990

Brief Summary

This study examines the effect of Entresto on central hemodynamic parameters during exercise in patients with diastolic dysfunction following acute myocardial infarction. Half of the patients will receive Entresto and the other half will receive placebo.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2018

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

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

Study Start

First participant enrolled

October 12, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

3.7 years

First QC Date

October 31, 2019

Last Update Submit

January 26, 2025

Conditions

Myocardial InfarctionDiastolic Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Central hemodynamics

    The primary endpoint will be the ratio of mean PCWP at peak exercise divided by cardiac index at peak exercise.

    26 weeks

Secondary Outcomes (6)

  • cardiac MRI

    26 weeks

  • Biomarker 1

    26 weeks

  • Biomarker 2

    26 weeks

  • Biomarker 3

    26 weeks

  • Echocardiographic 1

    26 weeks

  • +1 more secondary outcomes

Study Arms (2)

Entresto

ACTIVE COMPARATOR

Combination of valsartan and sacubitril titrated to 103+97 mg B.I.D. for 26 weeks

Drug: Entresto Pill

Placebo

PLACEBO COMPARATOR

Matching placebo B.I.D. for 26 weeks

Drug: Entresto Pill

Interventions

Entresto PillDRUG

NO other interventions

Also known as: Valsartan+ sacubitril
EntrestoPlacebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented ST segment elevation or non ST- myocardial infarction according to current guidelines
  • Complete revascularization
  • Age ≥50 years
  • LVEF ≥45% on echocardiography performed within 72 hours of the MI.
  • Diastolic dysfunction defined as: Ratio of early diastolic peak mitral inflow velocity (E) to early mitral annulus diastolic velocity (e') ratio \> 8 and at least moderate LA dilatation (LA volume index\>34 mL/m2).
  • Signed informed consent

You may not qualify if:

  • Intolerance towards study medication
  • Permanent atrial fibrillation,
  • Known history of cardiomyopathy,
  • More than mild valvular heart disease,
  • Severe obstructive or restrictive pulmonary disease,
  • Inability to perform exercise testing,
  • Inadequate acoustic windows on echocardiography,
  • Ongoing treatment with an angiotensin converting enzyme inhibitor at randomization.
  • Class I indication for an angiotensin converting enzyme inhibitor
  • Symptomatic hypotension, a systolic blood pressure of less than 100 mm Hg at screening
  • An estimated glomerular filtration rate (eGFR) below 30 ml per minute per 1.73 m2 of body-surface area at any time,
  • A serum potassium level of more than 5.2 mmol per liter at screening,
  • A history of hereditary or idiopathic angioedema or unacceptable side effects during receipt of angiotensin converting enzyme inhibitor or angiotensin receptor blocker
  • Inability to provide informed consent
  • Concomitant use of drugs containing aliskiren in patients with diabetes mellitus.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Cardiology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Cardiology, Odense Universityhospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Peter Hartmund Frederiksen, DMSC

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 4, 2019

Study Start

October 12, 2018

Primary Completion

July 6, 2022

Study Completion

June 6, 2023

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)