IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease

NCT03105219 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: NFH20170403
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.

Conditions

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Urinary albumin excretion

  Urinary albumin excretion at 3 month

  3 month

Secondary Outcomes (9)

• Serum creatinine

  3 month

• Blood urea nitrogen

  3 month

• Cyscatin-c

  3 month

• Hypersensitive c-reactive protein (hsCRP)

  3 month

• β2-microglobulin

  3 month

Study Arms (2)

Ivabradine

EXPERIMENTAL

Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day.

Drug: Ivabradine

Sham Comparator

SHAM COMPARATOR

Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28).

Other: Sham Comparator

Interventions

Ivabradine DRUG

Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day.

Ivabradine

Sham Comparator OTHER

Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28).

Sham Comparator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Type 2 diabetes and coronary heart disease;
• \. Urinary albumin excretion: 30-500mg/24h;
• \. Sinus rhythm, and resting heart rate ≥ 70bpm;

You may not qualify if:

• \. Renal dysfunction defined as eGFR \< 30ml/min/1.73m\^2;
• \. Atrial flutter, and atrial fibrillation;
• \. Resting heart rate \< 70bpm;
• \. Combined with non-dihydropyridine CCB;
• \. UAE\<30mg/24h, or \> 500mg/24h;
• \. Acute heart failure;
• \. Low blood pressure (BP\<90/50mmHg);
• \. Acute myocardial infarction (\<14 days);

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Shaoliang Chen, MD

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Urinary albumin excretion at 3 month
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 7, 2017
• Study Start: July 1, 2017
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)