Heart Failure AcuteNCT06414928
Prognostic Model Heart Failure
An observational study of Heart Failure Acute, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
Trial summary
This study aims to determine the prognosis of heart failure in our population by using multiple validated risk scores and to evaluate the strengths of these scores in assessing prognosis with better discrimination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Acute
- What is being tested?
- Acute Heart Failure
- How many people
- 1,000 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Feb 2024to 14 Jun 2026
- How long will I take part?
- 30 Days
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients presented at the Emergency Department with signs and symptoms of Acute Heart Failure who are fulfilling the eligibility criteria will be enrolled.
Who may be able to join
- Patients of age > 18 years or more
- Either gender
- Patients visited the emergency department at NICVD, Karachi
- Newly/Already diagnosed with Heart Failure
- Giving informed consent
- Who can be followed in 30 days via Telephone or in OPD
Who cannot join
- Patients of age <18 years
- Patients who do not give consent
- Patients who are mentally handicapped due to any neurological or psychiatric illness (excluding depression/anxiety)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
National Institute of Cardiovascular Diseases
Karachi, Sindh, 75510
Madiha Fatima, MBBS, FCPS, +923452325663, madihafatima89@hotmail.com
Rajesh Kumar, MBBS, FCPS, +923337306090, rajeshnarsoolal@gmail.com
About this study
Official title: In-hospital & 30-day Prognostication of Acute Heart Failure Patients by Comparing 4 Validated Scores in Patients Presenting to the Emergency Department of Cardiac Tertiary Care Hospital, Karachi- Pakistan
This study aims to determine the prognosis of heart failure in our population by using multiple validated risk scores and to evaluate the strengths of these scores in assessing prognosis with better discrimination.
Read the detailed description
After fulfilling the eligibility criteria, informed consent will be obtained from all the patients regarding using data for research while maintaining anonymity. All the included patients will be interviewed by the assigned physician to complete the detailed questionnaire, including patient demographics, risk factors, and validated questionnaires including the Acute Decompensated Heart Failure National Registry (ADHERE), The Get With The Guideline-Heart Failure (GWTG-HF) Risk Score, the Ottawa Heart Failure Risk Scale (OHFRS), and EHMRG30-ST score. All the patients will be followed after 30 days, and survival status will be obtained. The AUC of the GWTG-HF risk score for all-cause death was 0.687 (95% CI, 0.649-0.725) [18], at 95% confidence interval, ±3% margin of error, the sample size was calculated to be n=626 patients. The calculated sample size was inflated by a factor of 1.5 for the design effect; hence, the sample size for the study will be N=939.
For data verification, 10% of the data will be cross-checked with the source document (Patient file).
- Conditions
- Heart Failure Acute
- Being tested
- Acute Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Heart FailureOther
Consecutive patients presented at Emergency Departement with Acute Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Hospital Prognosis
Factors affecting in-hospital prognosis of patients with acute heart failure presented at Emergency of a tertiary care hospital
Measured: From admission till discharge/death
30-day Prognosis
Factors affecting the 30-day prognosis of patients with acute heart failure either via telephonic contact or re-admission or via OPD.
Measured: From day of admission of last visit till 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start14 Feb 2024
- Primary completion14 Feb 2026 (estimated)
- Study completion14 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure AcuteStudies 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
- 1,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madiha Fatima, National Institute of Cardiovascular Diseases, Pakistan
- Investigators
- Madiha Fatima, MBBS, FCPS, Principal investigator, National Institute of Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414928
- Sponsor's protocol ID
- IRB-63/2023
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Hospital Medical Record number will be used as the patient identifier.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-hospital & 30-day Prognostication of Acute Heart Failure Patients by Comparing 4 Validated Scores in Patients Presenting to the Emergency Department of Cardiac Tertiary Care Hospital, Karachi- Pakistan
- ClinicalTrials.gov ID
- NCT06414928
- Acronym / sponsor ID
- IRB-63/2023
- Conditions
- Heart Failure Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institute of Cardiovascular Diseases, PakistanUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 14 Feb 2026 (estimated)
- Study completion
- 14 Jun 2026 (estimated)
- First posted
- 16 May 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.
This study aims to determine the prognosis of heart failure in our population by using multiple validated risk scores and to evaluate the strengths of these scores in assessing prognosis with better discrimination.
Detailed description
After fulfilling the eligibility criteria, informed consent will be obtained from all the patients regarding using data for research while maintaining anonymity. All the included patients will be interviewed by the assigned physician to complete the detailed questionnaire, including patient demographics, risk factors, and validated questionnaires including the Acute Decompensated Heart Failure National Registry (ADHERE), The Get With The Guideline-Heart Failure (GWTG-HF) Risk Score, the Ottawa Heart Failure Risk Scale (OHFRS), and EHMRG30-ST score. All the patients will be followed after 30 days, and survival status will be obtained. The AUC of the GWTG-HF risk score for all-cause death was 0.687 (95% CI, 0.649-0.725) [18], at 95% confidence interval, ±3% margin of error, the sample size was calculated to be n=626 patients. The calculated sample size was inflated by a factor of 1.5 for the design effect; hence, the sample size for the study will be N=939.
For data verification, 10% of the data will be cross-checked with the source document (Patient file).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented at the Emergency Department with signs and symptoms of Acute Heart Failure who are fulfilling the eligibility criteria will be enrolled.
Key inclusion criteria (6 listed)
- Patients of age > 18 years or more
- Either gender
- Patients visited the emergency department at NICVD, Karachi
- Newly/Already diagnosed with Heart Failure
- Giving informed consent
Key exclusion criteria (3 listed)
- Patients of age <18 years
- Patients who do not give consent
- Patients who are mentally handicapped due to any neurological or psychiatric illness (excluding depression/anxiety)
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 |
|---|---|---|
| Acute Heart FailureConsecutive patients presented at Emergency Departement with Acute Heart Failure | Other | – |
Primary outcome
In-Hospital Prognosis
Time frame: From admission till discharge/death
Factors affecting in-hospital prognosis of patients with acute heart failure presented at Emergency of a tertiary care hospital
30-day Prognosis
Time frame: From day of admission of last visit till 30 days
Factors affecting the 30-day prognosis of patients with acute heart failure either via telephonic contact or re-admission or via OPD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No. The Hospital Medical Record number will be used as the patient identifier.
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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.
Madiha Fatima, MBBS, FCPS principal investigator
National Institute of Cardiovascular Diseases
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 Acute, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
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 6 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 16 May 2024. 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 Pakistan. 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 Madiha Fatima, MBBS, FCPS (+923452325663, madihafatima89@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-Hospital Prognosis (time frame: From admission till discharge/death). The study lists 2 primary outcomes in all. 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 16 May 2024.