The Effect of Sacubitril/valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients with Ischemic Heart Failure with Mid-range Ejection Fraction

PHASE3RecruitingINTERVENTIONAL
Enrollment

666

Participants

Timeline

Start Date

July 13, 2023

Primary Completion Date

March 31, 2027

Study Completion Date

June 30, 2027

Conditions
Heart Failure with Moderately Reduced Ejection Fraction
Interventions
DRUG

Sacubitril / Valsartan

The participants will be randomized to either ramipril 5 mg twice daily plus placebo for sacubitril / valsartan 200 mg twice daily or sacubitril / valsartan 200 mg twice daily plus placebo for ramipril 5 mg twice daily in 1: 1 ratio using the IT randomization module. All patients eligible for randomization will receive their first dose of double-blind drug plus placebo the day after randomization visit. After assigning a randomized treatment, patients will continue at the target dose and attend a 2-week telephone follow-up followed by site visits after one month, four months, eight months and in the final visit after 12 months.

DRUG

Ramipril

The participants will be randomized to either ramipril 5 mg twice daily plus placebo for sacubitril / valsartan 200 mg twice daily or sacubitril / valsartan 200 mg twice daily plus placebo for ramipril 5 mg twice daily in 1: 1 ratio using the IT randomization module. All patients eligible for randomization will receive their first dose of double-blind drug plus placebo the day after randomization visit. After assigning a randomized treatment, patients will continue at the target dose and attend a 2-week telephone follow-up followed by site visits after one month, four months, eight months and in the final visit after 12 months.

Trial Locations (1)

31-202

RECRUITING

Krakowski Szpital Specjalistyczny im. św. Jana Pawła II, Krakow

All Listed Sponsors
lead

John Paul II Hospital, Krakow

OTHER