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NCT Number: NCT01005303

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Placebo

Drug

1 Tablet Daily

Forceval plus 50 micrograms Vitamin D3

Drug

Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily

Primary outcomes

  1. Left Ventricular Ejection Fraction

    Time frame: Baseline, and 12 months

Secondary outcomes

  1. Quality of Life Questionnaire Score

    Time frame: Baseline, and 12 months

    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.

  2. Six Minute Walk Test Distance

    Time frame: Baseline, and 12 months

  3. Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration

    Time frame: Baseline, and 12 months

  4. Serum C-reactive Protein (CRP) Concentration

    Time frame: Baseline, and 12 months

  5. Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration

    Time frame: Baseline, and 12 months

  6. Serum Interleukin-6 (IL-6) Concentration

    Time frame: Baseline, and 12 months

  7. Serum Interleukin-10 (IL-10) Concentration

    Time frame: Baseline, and 12 months

  8. Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration

    Time frame: Baseline, and 12 months

Sponsors and collaborators

Lead sponsor

Belfast Health and Social Care Trust

Other

Registry information

Official study title

A Trial of Micronutrient Supplementation in Patients With Heart Failure

Acronym: MINT-HF

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
Oct 30, 2009
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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