Routine Magnesium Testing and Supplementation in Acute Heart Failure (MAG-HF) (MAG-HF)
Routine Magnesium Testing and Supplementation in Acute Heart Failure (MAG-HF): a Pragmatic Randomized Controlled Trial
This study is an investigator-initiated, pragmatic, randomized controlled feasibility trial evaluating two strategies for magnesium management in adults hospitalized with acute heart failure (AHF). Participants will be randomized to either a strategy of no routine magnesium testing or intravenous (IV) supplementation, or a strategy of routine magnesium testing with IV supplementation according to standard of care.
The primary objective is to determine the feasibility of conducting a definitive, multi-centre trial by assessing recruitment, consent, intervention adherence, and completeness of follow-up over a 30-day period. We plan to recruit 260 participants across two centres over approximately 24 months.
In addition to feasibility outcomes, clinical event rates will be evaluated to inform the design of a future definitive trial. These include all-cause death, all-cause hospital readmission, and heart failure readmission within 30 days of randomization, capturing events both during the index hospitalization and after discharge. In-hospital outcomes will include arrhythmia, symptomatic hypotension, serious adverse events, intensive care unit admission, and length of stay. Health-related quality of life will be assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at protocol-defined timepoints.
This trial is conducted within the HEART platform, a master protocol designed to evaluate multiple interventions in heart failure using a shared infrastructure.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
Acute heart failure (AHF) is a common cause of hospitalization and is associated with high rates of morbidity and rehospitalization. Magnesium abnormalities are frequently observed in hospitalized patients, and intravenous magnesium supplementation is commonly used in clinical practice despite limited evidence supporting routine testing and replacement strategies in this population. Variation in practice patterns exists, and the clinical impact of routine magnesium testing and supplementation in AHF remains uncertain.
The MAG-HF trial is an investigator-initiated, pragmatic, randomized controlled feasibility trial designed to evaluate the feasibility of conducting a definitive multi-centre trial comparing two strategies for magnesium management in adults hospitalized with AHF. Participants will be randomized to either a strategy of no routine magnesium testing or intravenous (IV) supplementation, or to a strategy of routine magnesium testing with IV supplementation according to standard of care. The study is conducted within the HEART platform, which provides a shared infrastructure to evaluate multiple interventions in heart failure.
The primary objective is to assess feasibility, including recruitment rates, consent rates, intervention adherence, and completeness of follow-up over 30 days. The study will enroll 260 participants across two centres over approximately 24 months.
In addition to feasibility outcomes, the trial will evaluate clinical event rates to inform the design of a future definitive study. Clinical outcomes assessed within 30 days of randomization will include all-cause death, all-cause hospital readmission, and heart failure readmission, capturing events both during the index hospitalization and after discharge. In-hospital outcomes during the index admission will include clinically significant arrhythmias, symptomatic hypotension, serious adverse events, intensive care unit admission, and length of hospital stay. Health-related quality of life will be assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at protocol-defined timepoints.
This feasibility trial is not powered to assess treatment effectiveness. Instead, the results will be used to inform the design, sample size, and operational considerations of a future definitive randomized controlled trial evaluating magnesium management strategies in AHF.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Justin Ezekowitz, MD
- Telefonszám: 780-492-0712
- E-mail: jae2@ualberta.ca
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Arnav Agarwal, MD
- Telefonszám: 780-407-8822
- E-mail: arnav.agarwal@ualberta.ca
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Adults aged ≥ 18 years admitted to hospital with a clinical diagnosis of suspected or confirmed AHF and with an elevated serum natriuretic peptide level on presentation will be eligible.
- Elevated natriuretic peptide levels are defined as a B-type natriuretic peptide (BNP) level of 400 pg/ml or higher; or a N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of 1000 pg/mL or higher.
Exclusion Criteria:
- Adults with an admission diagnosis other than AHF, presence of a pre-specified indication for magnesium supplementation on presentation (specified below), or having other medical conditions which, in the investigator's judgement, would make participation unsafe will be ineligible.
- Torsades de pointes
- Severe (< 3.0) or recurrent hypokalemia (< 3.5 x 2+ readings)
- Pre-eclampsia or eclampsia
- Severe asthma exacerbations
- Hypomagnesemia (< 0.70 mmol/L) within seven days of randomization. (Clarification Magnesium testing is not required to confirm hypomagnesemia).
- Concurrent enrolment will not automatically exclude a participant. Co-enrolment will be permitted only where allowed by both domain protocols and where the interventions and operational requirements are judged compatible. No washout is required after completion of a non-conflicting domain intervention.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egyéb
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Szekvenciális hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: No Routine Magnesium Testing or Supplementation
Participants assigned to a strategy of no routine magnesium testing and no routine intravenous magnesium supplementation during the index hospitalization |
A strategy in which no routine serum magnesium testing is performed and no routine intravenous magnesium supplementation is administered during the index hospitalization. |
|
Kísérleti: Routine Magnesium Testing and Supplementation
Participants assigned to a strategy of routine magnesium testing with intravenous magnesium supplementation administered according to standard of care. |
A strategy in which serum magnesium is measured and intravenous magnesium supplementation is administered according to standard of care during the index hospitalization. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Feasibility of trial conduct
Időkeret: Up to 30 days
|
Feasibility will be assessed by recruitment rate, consent rate, intervention fidelity, and completeness of follow-up and outcome ascertainment at 30 days. |
Up to 30 days
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Recruitment Rate
Időkeret: Up to 24 months (recruitment period)
|
Number of participants enrolled per site per month. |
Up to 24 months (recruitment period)
|
|
Consent Rate
Időkeret: Up to 30 days
|
Proportion of eligible patients who provide consent. |
Up to 30 days
|
|
Intervention Fidelity
Időkeret: During index hospitalization
|
Adherence to assigned strategy and separation between randomized groups. |
During index hospitalization
|
|
Completeness of Follow-up
Időkeret: Up to 30 days
|
Proportion of participants with complete follow-up and outcome ascertainment. |
Up to 30 days
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
All-Cause Mortality
Időkeret: Up to 30 days
|
All-cause death following randomization. |
Up to 30 days
|
|
All-Cause Hospital Readmission
Időkeret: Up to 30 days
|
Hospital readmission for any cause following discharge from the index hospitalization. |
Up to 30 days
|
|
Heart Failure Readmission
Időkeret: Up to 30 days
|
Hospital readmission due to heart failure following discharge from the index hospitalization. |
Up to 30 days
|
|
Clinically Significant Arrhythmia
Időkeret: Up to 30 days
|
Incident new or worsened clinically significant supraventricular or ventricular arrhythmia during the index hospitalization. |
Up to 30 days
|
|
Symptomatic Hypotension
Időkeret: During index hospitalization
|
Occurrence of symptomatic hypotension during the index hospitalization. |
During index hospitalization
|
|
Serious Adverse Events (SAEs)
Időkeret: Up to 30 days
|
Serious adverse events occurring during the index hospitalization. |
Up to 30 days
|
|
Intensive Care Unit (ICU) Admission
Időkeret: Up to 30 days
|
Admission to the intensive care unit during the index hospitalization. |
Up to 30 days
|
|
Length of Hospital Stay
Időkeret: Up to 30 days
|
Duration of the index hospitalization in days. |
Up to 30 days
|
|
Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)
Időkeret: Up to 30 days
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score from baseline to Day 5 comparing treatment groups. The Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) ranges from 0 to 100, where higher scores indicate fewer heart failure symptoms and better health status, and lower scores indicate more severe symptoms and worse health status. |
Up to 30 days
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Arnav Agarwal, MD, University of Alberta
Publikációk és hasznos linkek
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- MAG-01
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