Validation of ERTugliflozin for Inhibiting Cardiac Fibrosis Using Cardiac MRI and Laboratory Parameters in Korean Heart Failure Patients With Nonischemic Cardiomyopathy(VERTICAL)

NCT04490681 | Unknown Phase 3

• 1 other identifier: 4-2020-0484
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Based on recent studies demonstrating SGLT2 inhibitors' favorable effects on cardiovascular outcomes especially for heart failure, the investigators hypothesize that sodium-glucose co-transporter-2 (SGLT2) inhibitor, ertugliflozin, is effective on reducing cardiac fibrosis in patients with nonischemic cardiomyopathy so the investigators try to examine this hypothesis in a single-center, double-blind, randomized controlled study using cardiac magnetic resonance (CMR). This study is a prospective, single-center, randomized, double-blind, two arm parallel group, placebo-controlled clinical trial involving patients with nonischemic cardiomyopathy. Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 to ertugliflozin or placebo therapy, and cardiovascular functional assessment and clinical event follow-up will be undertaken.

Conditions

Heart Failure With Nonischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration

  The ECV value change in MRI from baseline to End of trial (48 weeks)

  Baseline

• The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration

  The ECV value change in MRI from baseline to End of trial (48 weeks)

  48 Weeks after drug administration

Secondary Outcomes (22)

• CMR parameters : ECV (%)

  baseline

• CMR parameters : ECV (%)

  12 weeks after drug administration

• CMR parameters : ECV (%)

  48 weeks after drug administration

• CMR parameters : Native T1 (ms)

  baseline

• CMR parameters : Native T1 (ms)

  12 weeks after drug administration

Study Arms (2)

Ertugliflozin

EXPERIMENTAL

Ertugliflozin 5mg

Drug: Ertugliflozin

placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ertugliflozin DRUG

Fixed dose Ertugliflozin (5mg)

Ertugliflozin

Placebo DRUG

Placebo group

placebo

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must agree to the study protocol and provide written informed consent
• Outpatients ≥ 19 years, \<75 years of age, male or female
• Non-diabetic or type 2 DM patients with HbA1c 7.0-10.5%
• Patients with nonischemic cardiomyopathy (LVEF ≤40%)
• Dyspnea of NYHA functional class II or III
• NT-proBNP ≥ 400 pg/ml (≥ 900 pg/ml if atrial fibrillation or atrial flutter)
• Titration of HF medications should be completed and patients must take a stable, optimized dose of a β-blocker and an ACE inhibitor (or ARB or ARNI if indicated) for at least 4 weeks prior to study entry

You may not qualify if:

• History of hypersensitivity or allergy to the study drug, drugs of similar chemical classes, or SGLT-2 as well as known or suspected contraindications to the study drug
• Current use or prior use of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor
• Known history of angioedema
• Current acute decompensated heart failure or dyspnea of NYHA functional class IV
• Medical history of hospitalization within 6 weeks
• Acute coronary syndrome, stroke, major CV surgery, PCI within 3 months
• Substantial myocardial ischemia requiring coronary revascularization therapy or a plan of coronary revascularization within 6 months
• A plan of heart transplantation or implantation of cardiac resynchronization therapy
• Symptomatic hypotension and/or a SBP \< 95 mmHg at screening
• Estimated GFR \< 30 mL/min/1.73m2
• History of ketoacidosis
• Symptomatic peripheral artery disease and history of lower limb amputation
• Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x upper limit of normal (ULN) at screening visit (Visit 0), history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt.
• History of severe pulmonary disease
• Significant mitral \& aortic valve disease (e.g. moderate to severe, severe degree)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospiatal

Seoul, South Korea

Location

MeSH Terms

Interventions

ertugliflozin

Central Study Contacts

Seok-Min Kang

CONTACT

82-2-2228-8450; smkang@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of randomized study, it will be masked to all participants, care providers, investigators, and outcomes assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 29, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)