Acute Heart FailureePVSNCT07085793
Estimated Plasma Volume in Patients With Acute Heart Failure
An observational study of Acute Heart Failure, run by University of Monastir at 1 site in Tunisia.
Trial summary
Congestion plays an essential role in acute heart failure (AHF) outcomes. Estimated plasma volume status (ePVS), derived from simple hematological parameters, may offer prognostic value. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Heart Failure
- How many people
- 2,500 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2019to 30 Dec 2023
- How long will I take part?
- 365 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute heart failure admetted in emergency department
Who may be able to join
None listed.
Who cannot join
- pregnancy
- end-stage or severe renal failure with creatinine clearance < 15 ml/min
- hemodialysis.
- refusal to consent
- Pregnant or breast feeding women.
- Alteration of consciousness GCS < 15
- Critically ill patients needing immediate mechanical hemodynamic of ventilatory support.
- Inability to follow instructions or comply with follow-up procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Estimated Plasma Volume in Patients With Acute Heart Failure
Congestion plays an essential role in acute heart failure (AHF) outcomes. Estimated plasma volume status (ePVS), derived from simple hematological parameters, may offer prognostic value.
The objectif is to assess the prognostic value of admission ePVS, calculated using Duarte and Hakim formulas, for short- and long-term mortality and/or readmission in patients hospitalized for AHF.
Read the detailed description
it is a prospective cross-sectional study in the emergency department of Fattouma Bourguiba University Hospital of Monastir, Tunisia.This study was approved by the Institutional Review Boardof our institute and conducted according to the revised Declaration of Helsinki. The requirement of written informed consent was waived, as this study is observational. an opt-out method was used for participant recruitment.
ePVS at admission was calculated as follows:
- Duarte ePVS= 100-ht(%) /Hb(g/dl).
- Hakim ePVS = [(actual plasma volume-ideal plasma volume)/ideal plasma volume] × 100 Actual plasma volume: (1-hematocrit) × (a+b×body weight in kg). Ideal plasma volume = c×body weight in kg. (males: a = 1530, b = 41.0, c = 39; females; a = 864, b = 47.9, c = 40)
- Conditions
- Acute Heart Failure
- Keywords
- Estimated plasma volume status (ePVS)
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 |
|---|---|---|
| 1 | 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
readmission for AHF and/or all-cause mortality
readmission for AHF and/or all-cause mortality at 1 month
Measured: 30 days
readmission for AHF and/or all-cause mortality
readmission for AHF and/or all-cause mortality
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Jan 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- 2,500 participants (actual)
- Target duration
- 365 Days
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Semir Nouira, Pr, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085793
- Sponsor's protocol ID
- Estimated plasma volume- ePVS
- Acronym
- ePVS
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Estimated Plasma Volume in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT07085793
- Acronym / sponsor ID
- ePVS / Estimated plasma volume- ePVS
- Conditions
- Acute Heart Failure
- Keywords
- Estimated plasma volume status (ePVS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 25 Jul 2025 (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.
Congestion plays an essential role in acute heart failure (AHF) outcomes. Estimated plasma volume status (ePVS), derived from simple hematological parameters, may offer prognostic value.
The objectif is to assess the prognostic value of admission ePVS, calculated using Duarte and Hakim formulas, for short- and long-term mortality and/or readmission in patients hospitalized for AHF.
Detailed description
it is a prospective cross-sectional study in the emergency department of Fattouma Bourguiba University Hospital of Monastir, Tunisia.This study was approved by the Institutional Review Boardof our institute and conducted according to the revised Declaration of Helsinki. The requirement of written informed consent was waived, as this study is observational. an opt-out method was used for participant recruitment.
ePVS at admission was calculated as follows:
- Duarte ePVS= 100-ht(%) /Hb(g/dl).
- Hakim ePVS = [(actual plasma volume-ideal plasma volume)/ideal plasma volume] × 100 Actual plasma volume: (1-hematocrit) × (a+b×body weight in kg). Ideal plasma volume = c×body weight in kg. (males: a = 1530, b = 41.0, c = 39; females; a = 864, b = 47.9, c = 40)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 365 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –1 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute heart failure admetted in emergency department
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- pregnancy
- end-stage or severe renal failure with creatinine clearance < 15 ml/min
- hemodialysis.
- refusal to consent
- Pregnant or breast feeding women.
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
readmission for AHF and/or all-cause mortality
Time frame: 30 days
readmission for AHF and/or all-cause mortality at 1 month
readmission for AHF and/or all-cause mortality
Time frame: 365 days
readmission for AHF and/or all-cause mortality
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 6 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Semir Nouira, Pr principal investigator
University of Monastir
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 Acute Heart Failure, run by University of Monastir at 1 site in Tunisia.
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 0 inclusion and 8 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 6 Aug 2025. 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 Tunisia. 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?
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?
readmission for AHF and/or all-cause mortality (time frame: 30 days). 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 6 Aug 2025.