Chronic Heart FailureNCT02292030
Cardioversion of Atrial Fibrillation Accompanied by Chronic Heart Faliure
An observational study of Chronic Heart Failure, run by Harbin Medical University at 2 sites in China.
Trial summary
The purpose of this study is to explore the efficacy of low energy cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- HTEA
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2014to Oct 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: congestive heart failure.
Who may be able to join
- congestive heart failure accompanied by atrial fibrillation.
Who cannot join
- Valvular heart diseases.
Trial locations and contacts
2 sites in 1 country.
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
Official title: Cardioversion of Atrial Fibrillation Accompanied by Chronic Heart Faliure With or Without HTEA
The purpose of this study is to explore the efficacy of low energy cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.
Read the detailed description
The purpose of this study is to explore the efficacy of low energy (30J) cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.
- Conditions
- Chronic Heart Failure
- Being tested
- HTEA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTEADrug
Also called High thoracic epidural anesthesia
usually high thoracic epidural anesthesia
| Study group | Role | What they receive |
|---|---|---|
| cardioversion+HTEA | Heart failure patients accompanied by atrial fibrillation receive the treatment of cardioversion+HTEA. Receives: Drug: HTEA | |
| only cardioversion | Heart failure patients accompanied by atrial fibrillation receive the treatment of cardioversion, but not with HTEA. Receives: Drug: HTEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of atrial fibrillation
Measured: 1 year
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 startNov 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Cohort
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292030
- Sponsor's protocol ID
- dong hao
- Status last verified
- Nov 2014
- First submitted
- 9 Nov 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
- Cardioversion of Atrial Fibrillation Accompanied by Chronic Heart Faliure With or Without HTEA
- ClinicalTrials.gov ID
- NCT02292030
- Acronym / sponsor ID
- dong hao
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 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 purpose of this study is to explore the efficacy of low energy cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.
Detailed description
The purpose of this study is to explore the efficacy of low energy (30J) cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardioversion+HTEA | – | Drug: HTEAHeart failure patients accompanied by atrial fibrillation receive the treatment of cardioversion+HTEA. |
| only cardioversion | – | Drug: HTEAHeart failure patients accompanied by atrial fibrillation receive the treatment of cardioversion, but not with HTEA. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- congestive heart failure.
Key inclusion criteria (1 listed)
- congestive heart failure accompanied by atrial fibrillation.
Key exclusion criteria (1 listed)
- Valvular heart 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 |
|---|---|---|
| HTEAAlso: High thoracic epidural anesthesiausually high thoracic epidural anesthesia | Drug | cardioversion+HTEA, only cardioversion |
Primary outcome
recurrence of atrial fibrillation
Time frame: 1 year
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.
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 Chronic 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of atrial fibrillation (time frame: 1 year). 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.