Heart FailureNCT02437331
Experience in Being With Advanced Heart Failure Patients
An observational study of Heart Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to explore the experience in being with advanced Heart failure patients. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2015to Apr 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: the study population is diagnosis of advanced heart failure with NYHA class 3 to 4.
Who may be able to join
- the patients' conscious must be clear,
- vital sign is stable,
- and can communicate in Mandarin Chinese or Taiwanese.
Who cannot join
- consciousness is unclear
- and can't have effective communication to interviewer.
- the patient reject to join this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Taipei University of Nursing and Health Science
The purpose of this study is to explore the experience in being with advanced Heart failure patients.
Read the detailed description
The aim is to explore the experience of advanced Heart failure patients during the disease trajectory in Taiwan.
- Conditions
- Heart Failure
- Keywords
- Advanced heart failure, diseased experience
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| advanced heart failure | the patients was diagnostic on Chronic heart failure with NYHA class 3 and 4, AHA stage D, or LVEF<40%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A qualitative research to decribe the experience with advanced Heart failure patients
describe patterns of diseases traits
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- keidei kao, master, Principal investigator, study
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437331
- Sponsor's protocol ID
- 201503067RIND
- Status last verified
- Oct 2016
- First submitted
- 22 Apr 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: because the data is still discussing with professional expert. and we think the data is not reach saturation yet.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taipei University of Nursing and Health Science
- ClinicalTrials.gov ID
- NCT02437331
- Acronym / sponsor ID
- 201503067RIND
- Conditions
- Heart Failure
- Keywords
- Advanced heart failure, diseased experience
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 7 May 2015 (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 experience in being with advanced Heart failure patients.
Detailed description
The aim is to explore the experience of advanced Heart failure patients during the disease trajectory in Taiwan.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| advanced heart failure | – | –the patients was diagnostic on Chronic heart failure with NYHA class 3 and 4, AHA stage D, or LVEF<40%. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the study population is diagnosis of advanced heart failure with NYHA class 3 to 4.
Key inclusion criteria (3 listed)
- the patients' conscious must be clear,
- vital sign is stable,
- and can communicate in Mandarin Chinese or Taiwanese.
Key exclusion criteria (3 listed)
- consciousness is unclear
- and can't have effective communication to interviewer.
- the patient reject to join this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A qualitative research to decribe the experience with advanced Heart failure patients
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks.
describe patterns of diseases traits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Individual participant dataSharing planned: Undecided. because the data is still discussing with professional expert. and we think the data is not reach saturation yet.
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 3
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Heart Failure
Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
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.
keidei kao, master principal investigator
study
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A qualitative research to decribe the experience with advanced Heart failure patients (time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks.). 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 13 Oct 2016.