IvaBradinE to Treat MicroalbumiNuria in Patients With Typ... | NCT03105219

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

NCT03105219

Sponsor

Nanjing First Hospital, Nanjing Medical University

Status

Withdrawn

Last Update Posted

Nov 9, 2020Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Diabetic Kidney Disease

Interventions

Ivabradine
Sham Comparator

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Shortfall in funding

Expanded Access Info

Start Date

Jul 1, 2017Estimated

Primary Completion Date

May 30, 2021Estimated

Completion Date

May 30, 2021Estimated

First Submitted Date

Apr 3, 2017

First Submission Date that Met QC Criteria

Apr 3, 2017

First Posted Date

Apr 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2020

Last Update Posted Date

Nov 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shaoliang Chen, Vice President, Nanjing First Hospital, Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

Nanjing First Hospital, Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This is a multi-center, randomized, open-label, investigator-initiated study with a parallel design. Patients with type 2 diabetes and coronary heart disease who are microalbuminuric [urinary albumin excretion (UAE): 30-500 mg/day], will be randomized after informed consent, in a 1:1 ratio to the following treatment groups: Group Α: 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.

Group Β: Placebo. 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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urinary albumin excretion	Urinary albumin excretion at 3 month	3 month

Secondary Outcomes

Measure	Description	Time Frame
Serum creatinine	Serum creatinine at 3 month	3 month
Blood urea nitrogen	Blood urea nitrogen at 3 month	3 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shaoliang Chen, MD	Nanjing First Hospital, Nanjing Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing First Hospital		Nanjing	Jiangsu	210006	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003928	Diabetic Nephropathies

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077550	Ivabradine

Ancestor Terms

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided