Effects of HTEA ON Heart Failure Secondary to Idiopathic... | NCT02292043

Studies
Effects of HTEA ON Heart Failure Secondary to Idiopathic Dilated Cardiomyopathy or Post-myocardial Infarction

NCT02292043

Sponsor

Harbin Medical University

Status

Unknown status

Last Update Posted

Nov 17, 2014Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Congestive Heart Failure

Interventions

HTEA

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 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jan 2015Estimated

Completion Date

Jan 2015Estimated

First Submitted Date

Oct 31, 2014

First Submission Date that Met QC Criteria

Nov 12, 2014

First Posted Date

Nov 17, 2014Estimated

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 12, 2014

Last Update Posted Date

Nov 17, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators would evaluate the effects of the novel method, HTEA on cardiac function in the heart failure patients secondary to idiopathic dilated cardiomyopathy and post-myocardial infarction.

Detailed Description

The investigators would evaluate the effects of the novel method, HTEA on cardiac function in the heart failure patients secondary to idiopathic dilated cardiomyopathy and post-myocardial infarction. The specific index is 6 miniutes walk distance, echocardiography, NYHA, NTproBNP level, peripherial WBC, RBC, PLT, Cre, UA, K+, Na+ upon entrance to hospital and 4 weeks after HTEA treatment, and 3 months after discharge. The morbidity and re-hospitalization would also calculated 3 months after discharge.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
idiopathic dilated cardiomyopathy group		idiopathic dilated cardiomyopathy group treated with HTEA	Drug: HTEA
post-myocardial infarction group		post-myocardial infarction group treated with TEA	Drug: HTEA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HTEA	Drug	HTEA	idiopathic dilated cardiomyopathy group post-myocardial infarction group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morbidity		1 months to 3 months after discharge

Secondary Outcomes

Measure	Description	Time Frame
The decreased degree of NT-proBNP higher than 30%		3 months after discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

90 chronic cardiac failure patients in our hospital were selected and divided into two groups.

Exclusion Criteria:

Vavular diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

heart failure.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
wei liu, Ph.D.	Contact	86-18904502999
xiaohui ren	Contact	86-451-85552320

Overall Officials

Name	Affiliation	Role
wei liu	First Affiliated Hospital of Harbin Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ren Xiaohui	Recruiting	Harbin	Heilongjiang	150001	China

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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