Heart FailurePhase 2/3MINT-HFNCT01005303
Micronutrient Supplementation in Patients With Heart Failure
A Phase 2/3 study testing Forceval plus 50 micrograms Vitamin D3 in people with Heart Failure, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
There is some evidence to suggest that patients with heart failure may have a reduced dietary intake of vitamins and essential minerals (micronutrients) and that this may worsen the function of the heart. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Forceval plus 50 micrograms Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Jul 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New York Heart Association Class II and III
- Already on or tried on best known medical treatment (ACE inhibitor and beta-blocker)
- Stable for a period of at least 6 weeks
- Left ventricular ejection fraction less than or equal to 45%
Who cannot join
- History of significant alcohol ingestion (more than 40 units per week)
- Severe renal dysfunction (GFR less than 30ml/min)
- Severe hepatic dysfunction (known liver disease or transaminases greater than 3 times the upper limit of normal)
- Atrial fibrillation (in the absence of a pacemaker)
- Frequent ventricular ectopics
- On waiting list for cardiac transplantation
Show all 13Show fewer
- Uncontrolled diabetes mellitus
- Inability to give informed consent
- Estimated life span less than 12 months
- Already taking a multivitamin/mineral supplement
- Already taking a vitamin-D containing fish oil
- Woman of child-bearing potential
- History of renal stones, hypercalcaemia, sarcoidosis, haemochromatosis or lactose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial of Micronutrient Supplementation in Patients With Heart Failure
There is some evidence to suggest that patients with heart failure may have a reduced dietary intake of vitamins and essential minerals (micronutrients) and that this may worsen the function of the heart. This study is designed to investigate if supplementation with micronutrients (including high-dose vitamin D) will improve the function of the heart in patients with heart failure.
- Conditions
- Heart Failure
- Being tested
- Placebo, Forceval plus 50 micrograms Vitamin D3
- Keywords
- Heart Failure, Micronutrients, Vitamin D, Inflammation, Oxidative Stress, Quality of Life, Physical Functioning
- Medical subject headings
- Heart Failure, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
1 Tablet Daily
Forceval plus 50 micrograms Vitamin D3Drug
Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Micronutrient | Active comparator | Not described Receives: Drug: Forceval plus 50 micrograms Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction
Measured: Baseline, and 12 months
Secondary outcomes (8)
Quality of Life Questionnaire Score
Minnesota Living With Heart Failure Questionnaire. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses (score range 0-105). Higher scores indicate worse quality of life.
Measured: Baseline, and 12 months
Six Minute Walk Test Distance
Measured: Baseline, and 12 months
Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration
Measured: Baseline, and 12 months
Serum C-reactive Protein (CRP) Concentration
Measured: Baseline, and 12 months
Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration
Measured: Baseline, and 12 months
Serum Interleukin-6 (IL-6) Concentration
Measured: Baseline, and 12 months
Serum Interleukin-10 (IL-10) Concentration
Measured: Baseline, and 12 months
Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration
Measured: Baseline, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal McKeown, Belfast Health and Social Care Trust
- Investigators
- Pascal McKeown, MD, Principal investigator, Belfast Health and Social Care TrustMark Harbinson, MD, Study director, Belfast Health and Socail Care TrustMichelle McKinley, PhD, Study director, The Queen's Univeristy of Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005303
- Sponsor's protocol ID
- RGHT000395
- Acronym
- MINT-HF
- Status last verified
- Feb 2023
- First submitted
- 29 Oct 2009
- Last updated
- 1 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McKeag NA, McKinley MC, Harbinson MT, Noad RL, Dixon LH, McGinty A, Neville CE, Woodside JV, McKeown PP. The effect of multiple micronutrient supplementation on left ventricular ejection fraction in patients with chronic stable heart failure: a randomized, placebo-controlled trial. JACC Heart Fail. 2014 Jun;2(3):308-17. doi: 10.1016/j.jchf.2013.12.008.
PubMed 24952700
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Micronutrient Supplementation in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01005303
- Acronym / sponsor ID
- MINT-HF / RGHT000395
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Micronutrients, Vitamin D, Inflammation, Oxidative Stress, Quality of Life, Physical Functioning
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Posted 1 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is some evidence to suggest that patients with heart failure may have a reduced dietary intake of vitamins and essential minerals (micronutrients) and that this may worsen the function of the heart. This study is designed to investigate if supplementation with micronutrients (including high-dose vitamin D) will improve the function of the heart in patients with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Micronutrient | Active comparator | Drug: Forceval plus 50 micrograms Vitamin D3 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- New York Heart Association Class II and III
- Already on or tried on best known medical treatment (ACE inhibitor and beta-blocker)
- Stable for a period of at least 6 weeks
- Left ventricular ejection fraction less than or equal to 45%
Key exclusion criteria (13 listed)
- History of significant alcohol ingestion (more than 40 units per week)
- Severe renal dysfunction (GFR less than 30ml/min)
- Severe hepatic dysfunction (known liver disease or transaminases greater than 3 times the upper limit of normal)
- Atrial fibrillation (in the absence of a pacemaker)
- Frequent ventricular ectopics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo1 Tablet Daily | Drug | Placebo |
| Forceval plus 50 micrograms Vitamin D3Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily | Drug | Micronutrient |
Primary outcome
Left Ventricular Ejection Fraction
Time frame: Baseline, and 12 months
8 secondary outcomes
Quality of Life Questionnaire Score
Time frame: Baseline, and 12 months
Six Minute Walk Test Distance
Time frame: Baseline, and 12 months
Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration
Time frame: Baseline, and 12 months
Serum C-reactive Protein (CRP) Concentration
Time frame: Baseline, and 12 months
Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration
Time frame: Baseline, and 12 months
Serum Interleukin-6 (IL-6) Concentration
Time frame: Baseline, and 12 months
Serum Interleukin-10 (IL-10) Concentration
Time frame: Baseline, and 12 months
Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration
Time frame: Baseline, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24952700McKeag NA, McKinley MC, Harbinson MT, Noad RL, Dixon LH, McGinty A, Neville CE, Woodside JV, McKeown PP. The effect of multiple micronutrient supplementation on left ventricular ejection fraction in patients with chronic stable heart failure: a randomized, placebo-controlled trial. JACC Heart Fail. 2014 Jun;2(3):308-17. doi: 10.1016/j.jchf.2013.12.008.
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
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Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
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Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
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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.
Pascal McKeown, MD principal investigator
Belfast Health and Social Care Trust
Mark Harbinson, MD study director
Belfast Health and Socail Care Trust
Michelle McKinley, PhD study director
The Queen's Univeristy of Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Forceval plus 50 micrograms Vitamin D3 in people with Heart Failure, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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 13 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 1 Dec 2023. 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 United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Left Ventricular Ejection Fraction (time frame: Baseline, and 12 months). 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 NCT01005303, which also lists 1 linked publication.
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 1 Dec 2023.