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Heart FailureSUCONICNCT06244693

SUbCONgestion in Heart Failure Registry

An observational study of Heart Failure and Congestion, run by University of Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to learn about the decongestion process in heart failure patients. The main question it aims to answer is: What is the behavior of congestion during hospitalization in adult patients with acute heart failure (AHF)? Participants will be evaluated in the decongestion process… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Congestion
How many people
49 participants
Where
1 siteChile
Study dates
1 Apr 2024to 7 Jan 2026
How long will I take part?
1 Year
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 with heart failure aged 18 years or above that are admitted in emergency room or outpatient clinic for acute decompensation of new or known heart failure, excluding diagnostics that mimics heart failure. Everyone has to be discharge from Hospital Clínico Universidad de Chile.

Who may be able to join

  • Adults diagnosed with decompensated heart failure in the emergency department or cardiology outpatient clinic at the Clinical Hospital of the University of Chile (HCUCh).
  • Profile of warm-wet and cold-wet type heart failure.
  • Spontaneous ventilation with or without non-invasive mechanical support.
  • Desire for participation validated through informed consent.

Who cannot join

  • Dry-type heart failure profile (warm and cold)
  • Diagnostics that mimics heart failure (valvular heart disease, cardiomyopathies, and others diagnostic different from heart failure).
  • Septic, distributive, or obstructive shock
  • Polytraumatized
  • Severe burns
  • Invasive mechanical ventilation
Show all 14Show fewer
  • Permanent renal replacement therapy
  • Severe dependence
  • Presence of terminal illness with a prognosis of survival less than one year
  • Presence of traumatic conditions that prevent the use of thoracic ultrasound, such as a flail chest or moderate to severe burn on the left hemithorax.
  • Lack of a support network or contact.
  • Cardiorespiratory arrest
  • Refusal to participate as indicated in the informed consent.
  • Presence of psychological or intellectual disability that prevents expressing the will to participate.

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Departamento Cardiovascular - Hospital Clínico Universidad de Chile

    Santiago, Metropolitan, 8380456

Other trials in Chile

About this study

Official title: Description and Analysis of Congestion During Hospitalization for Acute Decompensated Heart Failure

The goal of this observational study is to learn about the decongestion process in heart failure patients. The main question it aims to answer is: What is the behavior of congestion during hospitalization in adult patients with acute heart failure (AHF)? Participants will be evaluated in the decongestion process through clinical, analytical, and ultrasonographic variables, and they will be followed up for one year to assess mortality and rehospitalization rates in this population.

Read the detailed description

Heart failure (HF) is a syndrome characterized by the presence of dyspnea, lower extremity edema, orthopnea, jugular venous distention, and pulmonary crackles, among others, secondary to elevated ventricular filling pressures. It is the leading cause of hospitalization in medical services in Chile and worldwide, with the majority of patients being elderly. Decompensation of HF is explained in most cases by fluid overload (congestion) and can be studied through biomarkers, clinical signs, radiographic, and ultrasonographic findings. The Chilean demographic transition makes it necessary to optimize the multiparametric and protocolized management of hospitalized patients.

General Objective: To evaluate and describe the decongestion process, including residual congestion, during hospitalization for heart failure at the Clinical Hospital of the University of Chile (HCUCh).

A prospective observational cohort study will be conducted with all patients hospitalized for heart failure at HCUCh. Clinical, analytical, and ultrasonographic variables, especially those related to congestion assessment, will be recorded. Enrollment will last for one year from institutional authorization, and telephone follow-up will be conducted for one year post-discharge, extendable up to five year.

Being tested
No intervention
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

Study groups in NCT06244693
Study groupRoleWhat they receive
AHF PatientsAdmitted Acute Heart Failure Patients
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rehospitalization

    Readmission to hospital for cardiac cause

    Measured: One year from discharge

  2. All cause mortality

    Death from any cause

    Measured: One year after discharge

Secondary outcomes (1)

  1. Cardiac death

    Death form cardiac cause

    Measured: One year after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2024
  2. Study start1 Apr 2024
  3. Primary completion1 Jan 2026
  4. Study completion7 Jan 2026

Resources

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
49 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06244693
Sponsor's protocol ID
01-2024
Acronym
SUCONIC
Status last verified
Jan 2024
First submitted
29 Jan 2024
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Use data for compare with other populations in other studies.

Publications

  • McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

    PubMed 34447992

  • Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

    PubMed 35363499

  • Roger VL. Epidemiology of heart failure. Circ Res. 2013 Aug 30;113(6):646-59. doi: 10.1161/CIRCRESAHA.113.300268.

    PubMed 23989710

  • Castro P, Vukasovic JL, Garces E, Sepulveda L, Ferrada M, Alvarado S; Insuficiencia Cardiaca: Registro y Organizacion. [Cardiac failure in Chilean hospitals: results of the National Registry of Heart Failure, ICARO]. Rev Med Chil. 2004 Jun;132(6):655-62. doi: 10.4067/s0034-98872004000600001. Spanish.

    PubMed 15332366

  • Diaz-Toro F, Nazzal N C, Verdejo P H. [Incidence and hospital mortality due to heart failure. Are there any differences by sex?]. Rev Med Chil. 2017 Jun;145(6):703-709. doi: 10.4067/s0034-98872017000600703. No abstract available. Spanish.

    PubMed 29171617

  • Selvaraj S, Claggett B, Pozzi A, McMurray JJV, Jhund PS, Packer M, Desai AS, Lewis EF, Vaduganathan M, Lefkowitz MP, Rouleau JL, Shi VC, Zile MR, Swedberg K, Solomon SD. Prognostic Implications of Congestion on Physical Examination Among Contemporary Patients With Heart Failure and Reduced Ejection Fraction: PARADIGM-HF. Circulation. 2019 Oct 22;140(17):1369-1379. doi: 10.1161/CIRCULATIONAHA.119.039920. Epub 2019 Sep 12.

    PubMed 31510768

  • Pan D, Pellicori P, Dobbs K, Bulemfu J, Sokoreli I, Urbinati A, Brown O, Sze S, Rigby AS, Kazmi S, Riistama JM, Cleland JGF, Clark AL. Prognostic value of the chest X-ray in patients hospitalised for heart failure. Clin Res Cardiol. 2021 Nov;110(11):1743-1756. doi: 10.1007/s00392-021-01836-9. Epub 2021 Mar 22.

    PubMed 33754159

  • Ambrosy AP, Cerbin LP, Armstrong PW, Butler J, Coles A, DeVore AD, Dunlap ME, Ezekowitz JA, Felker GM, Fudim M, Greene SJ, Hernandez AF, O'Connor CM, Schulte P, Starling RC, Teerlink JR, Voors AA, Mentz RJ. Body Weight Change During and After Hospitalization for Acute Heart Failure: Patient Characteristics, Markers of Congestion, and Outcomes: Findings From the ASCEND-HF Trial. JACC Heart Fail. 2017 Jan;5(1):1-13. doi: 10.1016/j.jchf.2016.09.012.

    PubMed 28034373

  • Wettersten N. Biomarkers in Acute Heart Failure: Diagnosis, Prognosis, and Treatment. Int J Heart Fail. 2021 Feb 15;3(2):81-105. doi: 10.36628/ijhf.2020.0036. eCollection 2021 Apr.

    PubMed 36262882

  • Fonarow GC, Abraham WT, Albert NM, Gattis WA, Gheorghiade M, Greenberg B, O'Connor CM, Yancy CW, Young J. Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF): rationale and design. Am Heart J. 2004 Jul;148(1):43-51. doi: 10.1016/j.ahj.2004.03.004.

    PubMed 15215791

  • Ibrahim NE, Januzzi JL Jr. Beyond Natriuretic Peptides for Diagnosis and Management of Heart Failure. Clin Chem. 2017 Jan;63(1):211-222. doi: 10.1373/clinchem.2016.259564. Epub 2016 Oct 10.

    PubMed 28062619

  • Kumric M, Kurir TT, Bozic J, Glavas D, Saric T, Marcelius B, D'Amario D, Borovac JA. Carbohydrate Antigen 125: A Biomarker at the Crossroads of Congestion and Inflammation in Heart Failure. Card Fail Rev. 2021 Jun 12;7:e19. doi: 10.15420/cfr.2021.22. eCollection 2021 Mar.

    PubMed 34950509

  • D'Aloia A, Faggiano P, Aurigemma G, Bontempi L, Ruggeri G, Metra M, Nodari S, Dei Cas L. Serum levels of carbohydrate antigen 125 in patients with chronic heart failure: relation to clinical severity, hemodynamic and Doppler echocardiographic abnormalities, and short-term prognosis. J Am Coll Cardiol. 2003 May 21;41(10):1805-11. doi: 10.1016/s0735-1097(03)00311-5.

    PubMed 12767668

  • Nunez J, Llacer P, Bertomeu-Gonzalez V, Bosch MJ, Merlos P, Garcia-Blas S, Montagud V, Bodi V, Bertomeu-Martinez V, Pedrosa V, Mendizabal A, Cordero A, Gallego J, Palau P, Minana G, Santas E, Morell S, Llacer A, Chorro FJ, Sanchis J, Facila L; CHANCE-HF Investigators. Carbohydrate Antigen-125-Guided Therapy in Acute Heart Failure: CHANCE-HF: A Randomized Study. JACC Heart Fail. 2016 Nov;4(11):833-843. doi: 10.1016/j.jchf.2016.06.007. Epub 2016 Aug 10.

    PubMed 27522630

  • Nunez J, Minana G, Gonzalez M, Garcia-Ramon R, Sanchis J, Bodi V, Nunez E, Chorro FJ, Llacer A, Miguel A. Antigen carbohydrate 125 in heart failure: not just a surrogate for serosal effusions? Int J Cardiol. 2011 Feb 3;146(3):473-4. doi: 10.1016/j.ijcard.2010.12.027. Epub 2010 Dec 28. No abstract available.

    PubMed 21193243

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Congestion, run by University of Chile at 1 site in Chile.

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 4 inclusion and 14 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 11 May 2026. 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 Chile. 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?

Rehospitalization (time frame: One year from discharge). 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?

On the ClinicalTrials.gov record for NCT06244693, which also lists 23 linked publications.

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 11 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.

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