Chronic Heart FailurePhase 2VINDICATENCT01619891
VitamIN D Treating patIents With Chronic heArT failurE
A Phase 2 study testing Vitamin D in people with Chronic Heart Failure, run by University of Leeds at 1 site in United Kingdom.
Trial summary
Despite recent advances and even when receiving optimal therapy, patients with chronic heart failure (CHF) suffer poor quality of life, with recurrent hospitalisations and persistent symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Jan 2016
- Phase
- Phase 2
- 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
Who may be able to join
- Class II or III CHF
- Stable symptoms (on otherwise optimally tolerated medical therapy)
- Able to give written informed consent
Who cannot join
- Currently taking vitamin D supplementation
- Untreated valvular heart disease
- Existing class I indication for vitamin D therapy
- History of primary hyperparathyroidism, tuberculosis, sarcoidosis, malignancy or hypercalcaemia
- Heart failure due to anaemia or thyrotoxicosis
- Renal failure (GFR <30l/min)
Trial locations and contacts
1 site in 1 country.
About this study
Despite recent advances and even when receiving optimal therapy, patients with chronic heart failure (CHF) suffer poor quality of life, with recurrent hospitalisations and persistent symptoms. The investigators have shown that patients attending the Leeds Integrated Heart Failure Service are also frequently deficient in vitamin D and that the severity of the deficiency relates to the levels of symptoms, exercise capacity, diuretic requirements and response to optimal medical therapy. Vitamin D contributes to cardiac and skeletal muscle contractile function, immune function, pancreatic insulin release, and neuro-hormonal homeostasis. A randomised, placebo-controlled proof of concept study in 60 CHF patients has demonstrated improvements in submaximal exercise capacity and symptoms. VINDICATE will be a randomised, placebo-controlled developmental clinical study in 250 patients with CHF and vitamin D deficiency. The present study is designed to detect whether vitamin D has pathophysiologically important effects, as well as providing preliminary evidence of efficacy and safety by examining cardiac function (using cardiac magnetic resonance imaging) and submaximal exercise capacity (by 6-minute walk test). This will provide pertinent data to inform a larger multi-centre efficacy and effectiveness study.
Read the detailed description
This is a randomized placebo-controlled trial of vitamin D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.
- Conditions
- Chronic Heart Failure
- Being tested
- Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
100mcg per day
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Vitamin D 100mcg per day Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Standard optimal therapy Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk distance
Measured: After one year
Secondary outcomes (3)
Left ventricular function by Cardiac Magnetic Resonance
Measured: At one year
Peak exercise capacity
Measured: At one year
Biochemical changes
Measured: At one year (but also throughout)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KK Witte, University of Leeds
- Investigators
- Klaus K Witte, MD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619891
- Sponsor's protocol ID
- MR/J00281X/1
- Acronym
- VINDICATE
- Status last verified
- Oct 2016
- First submitted
- 12 Jun 2012
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Witte KK, Byrom R, Gierula J, Paton MF, Jamil HA, Lowry JE, Gillott RG, Barnes SA, Chumun H, Kearney LC, Greenwood JP, Plein S, Law GR, Pavitt S, Barth JH, Cubbon RM, Kearney MT. Effects of Vitamin D on Cardiac Function in Patients With Chronic HF: The VINDICATE Study. J Am Coll Cardiol. 2016 Jun 7;67(22):2593-603. doi: 10.1016/j.jacc.2016.03.508. Epub 2016 Apr 4.
PubMed 27058906
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VitamIN D Treating patIents With Chronic heArT failurE
- ClinicalTrials.gov ID
- NCT01619891
- Acronym / sponsor ID
- VINDICATE / MR/J00281X/1
- Conditions
- Chronic Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite recent advances and even when receiving optimal therapy, patients with chronic heart failure (CHF) suffer poor quality of life, with recurrent hospitalisations and persistent symptoms. The investigators have shown that patients attending the Leeds Integrated Heart Failure Service are also frequently deficient in vitamin D and that the severity of the deficiency relates to the levels of symptoms, exercise capacity, diuretic requirements and response to optimal medical therapy. Vitamin D contributes to cardiac and skeletal muscle contractile function, immune function, pancreatic insulin release, and neuro-hormonal homeostasis. A randomised, placebo-controlled proof of concept study in 60 CHF patients has demonstrated improvements in submaximal exercise capacity and symptoms. VINDICATE will be a randomised, placebo-controlled developmental clinical study in 250 patients with CHF and vitamin D deficiency. The present study is designed to detect whether vitamin D has pathophysiologically important effects, as well as providing preliminary evidence of efficacy and safety by examining cardiac function (using cardiac magnetic resonance imaging) and submaximal exercise capacity (by 6-minute walk test). This will provide pertinent data to inform a larger multi-centre efficacy and effectiveness study.
Detailed description
This is a randomized placebo-controlled trial of vitamin D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Dietary Supplement: Vitamin DVitamin D 100mcg per day |
| Placebo | Placebo comparator | Dietary Supplement: Vitamin DStandard optimal therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Class II or III CHF
- Stable symptoms (on otherwise optimally tolerated medical therapy)
- Able to give written informed consent
Key exclusion criteria (6 listed)
- Currently taking vitamin D supplementation
- Untreated valvular heart disease
- Existing class I indication for vitamin D therapy
- History of primary hyperparathyroidism, tuberculosis, sarcoidosis, malignancy or hypercalcaemia
- Heart failure due to anaemia or thyrotoxicosis
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 |
|---|---|---|
| Vitamin D100mcg per day | Dietary supplement | Placebo, Vitamin D |
Primary outcome
6 minute walk distance
Time frame: After one year
3 secondary outcomes
Left ventricular function by Cardiac Magnetic Resonance
Time frame: At one year
Peak exercise capacity
Time frame: At one year
Biochemical changes
Time frame: At one year (but also throughout)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 27058906Witte KK, Byrom R, Gierula J, Paton MF, Jamil HA, Lowry JE, Gillott RG, Barnes SA, Chumun H, Kearney LC, Greenwood JP, Plein S, Law GR, Pavitt S, Barth JH, Cubbon RM, Kearney MT. Effects of Vitamin D on Cardiac Function in Patients With Chronic HF: The VINDICATE Study. J Am Coll Cardiol. 2016 Jun 7;67(22):2593-603. doi: 10.1016/j.jacc.2016.03.508. Epub 2016 Apr 4.
- Individual participant dataSharing planned: Yes
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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.
Klaus K Witte, MD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D in people with Chronic Heart Failure, run by University of Leeds 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 3 inclusion and 6 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 26 Oct 2016. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
6 minute walk distance (time frame: After one year). 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 NCT01619891, 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 26 Oct 2016.