Congestive Heart FailureNCT02292043
Effects of HTEA ON Heart Failure Secondary to Idiopathic Dilated Cardiomyopathy or Post-myocardial Infarction
An observational study of Congestive Heart Failure, run by Harbin Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- HTEA
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- May 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: heart failure.
Who may be able to join
- 90 chronic cardiac failure patients in our hospital were selected and divided into two groups.
Who cannot join
- Vavular diseases
Trial locations and contacts
2 sites in 1 country.
wei liu, Ph.D. contact
xiaohui ren contact
China2 sites, 2 recruiting
- Recruiting
Ren Xiaohui
Harbin, Heilongjiang, 150001
Xiaohui Ren, 86-85552320, renxiaohui2004@163.com
- Recruiting
the first affiliated hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Xiaohui Ren, 86-451-85552320
About this study
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.
Read the 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.
- Conditions
- Congestive Heart Failure
- Being tested
- HTEA
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTEADrug
HTEA
| Study group | Role | What they receive |
|---|---|---|
| idiopathic dilated cardiomyopathy group | idiopathic dilated cardiomyopathy group treated with HTEA Receives: Drug: HTEA | |
| post-myocardial infarction group | post-myocardial infarction group treated with TEA Receives: Drug: HTEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Measured: 1 months to 3 months after discharge
Secondary outcomes (1)
The decreased degree of NT-proBNP higher than 30%
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startMay 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Liu, Harbin Medical University
- Investigators
- wei liu, Principal investigator, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292043
- Sponsor's protocol ID
- wei liu
- Status last verified
- Nov 2014
- First submitted
- 31 Oct 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of HTEA ON Heart Failure Secondary to Idiopathic Dilated Cardiomyopathy or Post-myocardial Infarction
- ClinicalTrials.gov ID
- NCT02292043
- Acronym / sponsor ID
- wei liu
- Conditions
- Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| idiopathic dilated cardiomyopathy group | – | Drug: HTEAidiopathic dilated cardiomyopathy group treated with HTEA |
| post-myocardial infarction group | – | Drug: HTEApost-myocardial infarction group treated with TEA |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- heart failure.
Key inclusion criteria (1 listed)
- 90 chronic cardiac failure patients in our hospital were selected and divided into two groups.
Key exclusion criteria (1 listed)
- Vavular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTEAHTEA | Drug | idiopathic dilated cardiomyopathy group, post-myocardial infarction group |
Primary outcome
Morbidity
Time frame: 1 months to 3 months after discharge
1 secondary outcome
The decreased degree of NT-proBNP higher than 30%
Time frame: 3 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wei liu, Ph.D. contact
xiaohui ren contact
wei liu principal investigator
First Affiliated Hospital of Harbin Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Harbin Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wei liu, Ph.D. (86-18904502999), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: 1 months to 3 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2014.