NCT07194889

Brief Summary

Heart failure (HF) affects over 64 million people worldwide and carries high morbidity, frequent hospitalizations, and major economic burden. Accurate risk stratification is essential to guide therapy, follow-up, and advanced care decisions. Several prognostic models have been developed: MAGGIC: based on \>39,000 patients, predicts mortality from simple clinical variables. GWTG-HF: derived from \>30,000 patients, predicts in-hospital mortality using admission data. SHFM: estimates 1-3 year survival, incorporating clinical, lab, and treatment factors. These models, developed mainly in Western cohorts, may not perform well in Arab populations, where HF patients are younger, with more ischemic disease, diabetes, CKD, and limited access to advanced therapies. Such differences risk score miscalibration. External validation and recalibration are needed to assess predictive accuracy and adjust models for local populations. A head-to-head comparison of MAGGIC, GWTG-HF, and SHFM has never been done in Egypt; such a study would identify the most reliable model for predicting 1-year mortality and 30-day readmission in Egyptian HF patients.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Oct 2025Oct 2027

First Submitted

Initial submission to the registry

September 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 19, 2025

Last Update Submit

September 26, 2025

Conditions

Keywords

Heart failureRisk ModelsValidation and RecalibrationEgyptian patients

Outcome Measures

Primary Outcomes (1)

  • Validation and Recalibration

    * To externally validate the MAGGIC, GWTG-HF, and SHFM models for predicting all-cause mortality at 1 year in Egyptian HF patients. * To validate the same models for predicting 30-day all-cause readmission * In-hospital mortality (for GWTG-HF validation). * All-cause mortality at 30 days and 1 year (for MAGGIC \& SHFM).

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Egyptian patients with heart failure

You may qualify if:

  • Age ≥18 years.
  • Clinical HF diagnosis (per ESC/ACC/AHA criteria).
  • Available baseline data to compute ≥1 of the three scores within 24h of index assessment (admission or clinic baseline).
  • For longitudinal endpoints: reachable for follow-up.

You may not qualify if:

  • Cardiogenic shock requiring immediate MCS at presentation (analyzed separately).
  • Isolated right HF from primary pulmonary disease without LV involvement (for main analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Hassanin A, Hassanein M, Bendary A, Maksoud MA. Demographics, clinical characteristics, and outcomes among hospitalized heart failure patients across different regions of Egypt. Egypt Heart J. 2020 Aug 13;72(1):49. doi: 10.1186/s43044-020-00082-0.

    PMID: 32789717BACKGROUND
  • AlHabib KF, Elasfar AA, Alfaleh H, Kashour T, Hersi A, AlBackr H, Alshaer F, AlNemer K, Hussein GA, Mimish L, Almasood A, AlHabeeb W, AlGhamdi S, Alsharari M, Chakra E, Malik A, Soomro R, Ghabashi A, Al-Murayeh M, Abuosa A. Clinical features, management, and short- and long-term outcomes of patients with acute decompensated heart failure: phase I results of the HEARTS database. Eur J Heart Fail. 2014 Apr;16(4):461-9. doi: 10.1002/ejhf.57.

    PMID: 24515441BACKGROUND
  • Ibrahim MM, Damasceno A. Hypertension in developing countries. Lancet. 2012 Aug 11;380(9841):611-9. doi: 10.1016/S0140-6736(12)60861-7.

    PMID: 22883510BACKGROUND
  • Sliwa K, Davison BA, Mayosi BM, Damasceno A, Sani M, Ogah OS, Mondo C, Ojji D, Dzudie A, Kouam Kouam C, Suliman A, Schrueder N, Yonga G, Ba SA, Maru F, Alemayehu B, Edwards C, Cotter G. Readmission and death after an acute heart failure event: predictors and outcomes in sub-Saharan Africa: results from the THESUS-HF registry. Eur Heart J. 2013 Oct;34(40):3151-9. doi: 10.1093/eurheartj/eht393. Epub 2013 Sep 18.

    PMID: 24048728BACKGROUND
  • Pocock SJ, Ariti CA, McMurray JJ, Maggioni A, Kober L, Squire IB, Swedberg K, Dobson J, Poppe KK, Whalley GA, Doughty RN; Meta-Analysis Global Group in Chronic Heart Failure. Predicting survival in heart failure: a risk score based on 39 372 patients from 30 studies. Eur Heart J. 2013 May;34(19):1404-13. doi: 10.1093/eurheartj/ehs337. Epub 2012 Oct 24.

    PMID: 23095984BACKGROUND
  • Aaronson KD, Schwartz JS, Chen TM, Wong KL, Goin JE, Mancini DM. Development and prospective validation of a clinical index to predict survival in ambulatory patients referred for cardiac transplant evaluation. Circulation. 1997 Jun 17;95(12):2660-7. doi: 10.1161/01.cir.95.12.2660.

    PMID: 9193435BACKGROUND
  • Levy WC, Mozaffarian D, Linker DT, Sutradhar SC, Anker SD, Cropp AB, Anand I, Maggioni A, Burton P, Sullivan MD, Pitt B, Poole-Wilson PA, Mann DL, Packer M. The Seattle Heart Failure Model: prediction of survival in heart failure. Circulation. 2006 Mar 21;113(11):1424-33. doi: 10.1161/CIRCULATIONAHA.105.584102. Epub 2006 Mar 13.

    PMID: 16534009BACKGROUND
  • Shiraishi Y, Kohsaka S, Abe T, Mizuno A, Goda A, Izumi Y, Yagawa M, Akita K, Sawano M, Inohara T, Takei M, Kohno T, Higuchi S, Yamazoe M, Mahara K, Fukuda K, Yoshikawa T; West Tokyo Heart Failure Registry Investigators. Validation of the Get With The Guideline-Heart Failure risk score in Japanese patients and the potential improvement of its discrimination ability by the inclusion of B-type natriuretic peptide level. Am Heart J. 2016 Jan;171(1):33-9. doi: 10.1016/j.ahj.2015.10.008. Epub 2015 Nov 11.

    PMID: 26699598BACKGROUND
  • Matsue Y, Damman K, Voors AA, Kagiyama N, Yamaguchi T, Kuroda S, Okumura T, Kida K, Mizuno A, Oishi S, Inuzuka Y, Akiyama E, Matsukawa R, Kato K, Suzuki S, Naruke T, Yoshioka K, Miyoshi T, Baba Y, Yamamoto M, Murai K, Mizutani K, Yoshida K, Kitai T. Time-to-Furosemide Treatment and Mortality in Patients Hospitalized With Acute Heart Failure. J Am Coll Cardiol. 2017 Jun 27;69(25):3042-3051. doi: 10.1016/j.jacc.2017.04.042.

    PMID: 28641794BACKGROUND
  • Peterson PN, Rumsfeld JS, Liang L, Albert NM, Hernandez AF, Peterson ED, Fonarow GC, Masoudi FA; American Heart Association Get With the Guidelines-Heart Failure Program. A validated risk score for in-hospital mortality in patients with heart failure from the American Heart Association get with the guidelines program. Circ Cardiovasc Qual Outcomes. 2010 Jan;3(1):25-32. doi: 10.1161/CIRCOUTCOMES.109.854877. Epub 2009 Dec 8.

    PMID: 20123668BACKGROUND
  • Sawano M, Shiraishi Y, Kohsaka S, Nagai T, Goda A, Mizuno A, Sujino Y, Nagatomo Y, Kohno T, Anzai T, Fukuda K, Yoshikawa T. Performance of the MAGGIC heart failure risk score and its modification with the addition of discharge natriuretic peptides. ESC Heart Fail. 2018 Aug;5(4):610-619. doi: 10.1002/ehf2.12278. Epub 2018 Mar 9.

    PMID: 29520978BACKGROUND
  • Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.

    PMID: 28785469BACKGROUND
  • Groenewegen A, Rutten FH, Mosterd A, Hoes AW. Epidemiology of heart failure. Eur J Heart Fail. 2020 Aug;22(8):1342-1356. doi: 10.1002/ejhf.1858. Epub 2020 Jun 1.

    PMID: 32483830BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 19, 2025

First Posted

September 26, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

October 1, 2025

Record last verified: 2025-09