Heart Failure With Reduced Ejection FractionNCT06382571
Factors Associated With Sub - Targeted Therapeutic Dose Of Renin - Angiotensin Blockage Among Chronic Heart Failure With Reduced Ejection Fraction Patients
An observational study of Heart Failure With Reduced Ejection Fraction, run by Chulalongkorn University.
Trial summary
Objective: To analyze factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Renin-Angiotensin System Inhibitor
- How many people
- 396 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult out - patients who were first diagnosed be heart failure with left vetricular ejection fraction less than 40% and recieved one of ACEIs,ARBs,ARNI drugs.
Who may be able to join
- Patients who were first diagnosed be heart failure with left ventricular ejection fraction less than 40%.
- Received one of ACEIs,ARBs,ARNI drugs.
Who cannot join
- Electronic medical records was not complete enough to analyse.
- Patients who had history of heart transplantation or had heart transplantation plan in last 12 months.
About this study
Objective: To analyze factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs).
Methods: The retrospective cohort study was designed to collect data on Thai heart failure with reduced ejection fraction patients at Out-patient Clinic, Trat Hospital and Phrapokklao Hospital from January 2016 to December 2020. Thirteen factors were analyzed to determine their association with the sub-target group.
- Being tested
- Renin-Angiotensin System Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renin-Angiotensin System InhibitorDrug
| Study group | Role | What they receive |
|---|---|---|
| Sub - target dose group | Patients who received sub - target dose of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs). Receives: Drug: Renin-Angiotensin System Inhibitor | |
| Target dose group | Patients who received target dose or maximal tolerated dose of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs) Receives: Drug: Renin-Angiotensin System Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
factors associated with sub - target dose of ACEIs,ARBs,ARNI
factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Jan 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382571
- Sponsor's protocol ID
- 026/66
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Sub - Targeted Therapeutic Dose Of Renin - Angiotensin Blockage Among Chronic Heart Failure With Reduced Ejection Fraction Patients
- ClinicalTrials.gov ID
- NCT06382571
- Acronym / sponsor ID
- 026/66
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Apr 2024 (actual)
- 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.
Objective: To analyze factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs).
Methods: The retrospective cohort study was designed to collect data on Thai heart failure with reduced ejection fraction patients at Out-patient Clinic, Trat Hospital and Phrapokklao Hospital from January 2016 to December 2020. Thirteen factors were analyzed to determine their association with the sub-target group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub - target dose group | – | Drug: Renin-Angiotensin System InhibitorPatients who received sub - target dose of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs). |
| Target dose group | – | Drug: Renin-Angiotensin System InhibitorPatients who received target dose or maximal tolerated dose of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult out - patients who were first diagnosed be heart failure with left vetricular ejection fraction less than 40% and recieved one of ACEIs,ARBs,ARNI drugs.
Key inclusion criteria (2 listed)
- Patients who were first diagnosed be heart failure with left ventricular ejection fraction less than 40%.
- Received one of ACEIs,ARBs,ARNI drugs.
Key exclusion criteria (2 listed)
- Electronic medical records was not complete enough to analyse.
- Patients who had history of heart transplantation or had heart transplantation plan in last 12 months.
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 |
|---|---|---|
| Renin-Angiotensin System Inhibitor | Drug | Sub - target dose group, Target dose group |
Primary outcome
factors associated with sub - target dose of ACEIs,ARBs,ARNI
Time frame: 12 months
factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction, run by Chulalongkorn University.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
factors associated with sub - target dose of ACEIs,ARBs,ARNI (time frame: 12 months). 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 24 Apr 2024.