Routine Magnesium Testing and Supplementation in Acute Heart Failure (MAG-HF) (MAG-HF)

November 4, 2026 updated by: University of Alberta

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: No Routine Magnesium Testing or Supplementation

A strategy in which no routine serum magnesium testing is performed and no routine intravenous magnesium supplementation is administered during the index hospitalization.
Experimental: Routine Magnesium Testing and Supplementation

Participants assigned to a strategy of routine magnesium testing with intravenous magnesium supplementation administered according to standard of care.
Other: Routine Magnesium Testing and Supplementation

A strategy in which serum magnesium is measured and intravenous magnesium supplementation is administered according to standard of care during the index hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of trial conduct
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Up to 24 months (recruitment period)

Number of participants enrolled per site per month.
Up to 24 months (recruitment period)
Consent Rate
Time Frame: Up to 30 days

Proportion of eligible patients who provide consent.
Up to 30 days
Intervention Fidelity
Time Frame: During index hospitalization

Adherence to assigned strategy and separation between randomized groups.
During index hospitalization
Completeness of Follow-up
Time Frame: Up to 30 days

Proportion of participants with complete follow-up and outcome ascertainment.
Up to 30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: Up to 30 days

All-cause death following randomization.
Up to 30 days
All-Cause Hospital Readmission
Time Frame: Up to 30 days

Hospital readmission for any cause following discharge from the index hospitalization.
Up to 30 days
Heart Failure Readmission
Time Frame: Up to 30 days

Hospital readmission due to heart failure following discharge from the index hospitalization.
Up to 30 days
Clinically Significant Arrhythmia
Time Frame: Up to 30 days

Incident new or worsened clinically significant supraventricular or ventricular arrhythmia during the index hospitalization.
Up to 30 days
Symptomatic Hypotension
Time Frame: During index hospitalization

Occurrence of symptomatic hypotension during the index hospitalization.
During index hospitalization
Serious Adverse Events (SAEs)
Time Frame: Up to 30 days

Serious adverse events occurring during the index hospitalization.
Up to 30 days
Intensive Care Unit (ICU) Admission
Time Frame: Up to 30 days

Admission to the intensive care unit during the index hospitalization.
Up to 30 days
Length of Hospital Stay
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Arnav Agarwal, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

October 24, 2026

First Posted (Actual)

October 30, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAG-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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