Heart FailurePhase 2/3ECSPLOIT -DNCT01477801
Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels
A Phase 2/3 study testing CHOLECALCIFEROL in people with Heart Failure and Vitamin D Deficiency, run by Azienda Unita' Sanitaria Locale Di Modena at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether cholecalciferol supplementation in patients with chronic heart failure and low vitamin D levels improves: 1. performance at six minutes walking test 2. echocardiographic parameters 3. neurohormonal imbalance Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure, Vitamin D Deficiency
- What is being tested?
- CHOLECALCIFEROL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to Sep 2012
- Phase
- Phase 2/3
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure diagnosis according to European Society of Cardiology Guideline criteria
- Age > 60 years old
- 25(OH) Vitamin D level < 30 ng/ml
- Clinical and therapeutic stability for one month (NYHA class II or III)
Who cannot join
- Chronic use of anticonvulsants or barbiturates, steroids, thiazides, aluminium or magnesium, colestipol or cholestyramine
- Glomerular filtration rate lower than 30 ml/min/1.73 m2 according to MDRD equation
- Nephrolitiasis, Sarcoidosis or hypercalcemia
- Recent (three months) acute coronary syndrome or stroke or major vascular surgery
- Reduced life expectancy due to other diseases (active neoplasms, liver cirrhosis...)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Medicina Cardiovascolare - NOCSAE - Azienda USL
Modena, (mo), 41100
Fabrizio Turrini, MD, 0039593961100, f.turrini@ausl.mo.it
Stefania Scarlini
About this study
Official title: Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels. A Phase 2 Randomized Double Blind Study
The purpose of this study is to determine whether cholecalciferol supplementation in patients with chronic heart failure and low vitamin D levels improves:
- performance at six minutes walking test
- echocardiographic parameters
- neurohormonal imbalance
- Conditions
- Heart Failure, Vitamin D Deficiency
- Being tested
- CHOLECALCIFEROL, PLACEBO
- Medical subject headings
- Heart Failure, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOLECALCIFEROLDrug
Also called DIBASE (ABIOGEN PHARMA)
Standard guideline based therapy plus cholecalciferol:
Loading dose 300.000 U then 50.000 U every month for six months
PLACEBODrug
Standard guideline based therapy plus placebo
| Study group | Role | What they receive |
|---|---|---|
| CHOLECALCIFEROL | Experimental | Not described Receives: Drug: CHOLECALCIFEROL |
| PLACEBO | Placebo comparator | Not described Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIX MINUTE WALKING TEST DISTANCE
Measured: six months
Secondary outcomes (2)
ECHOCARDIOGRAPHIC PARAMETERS
Measured: six months
NEUROHORMONAL CHANGES
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Unita' Sanitaria Locale Di Modena
- Sponsor type
- University, hospital or other
- Collaborators
- Abiogen Pharma
- Responsible party
- Principal investigator, TURRINI FABRIZIO, Azienda Unita' Sanitaria Locale Di Modena
- Investigators
- Fabrizio Turrini, MD, Principal investigator, Azienda USL di ModenaMarco Bondi, MD, Study director, Azienda USL di ModenaPaola Loria, MD, Study chair, Università di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477801
- Sponsor's protocol ID
- MCV-MO-11-001
- Other IDs
- 2011-001726-14
- Acronym
- ECSPLOIT -D
- Status last verified
- Nov 2011
- First submitted
- 18 Nov 2011
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels. A Phase 2 Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT01477801
- Acronym / sponsor ID
- ECSPLOIT -D / MCV-MO-11-001
- Conditions
- Heart Failure, Vitamin D Deficiency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Azienda Unita' Sanitaria Locale Di ModenaUniversity, hospital or other
- Collaborators
- Abiogen Pharma
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 23 Nov 2011 (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.
The purpose of this study is to determine whether cholecalciferol supplementation in patients with chronic heart failure and low vitamin D levels improves:
- performance at six minutes walking test
- echocardiographic parameters
- neurohormonal imbalance
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 |
|---|---|---|
| CHOLECALCIFEROL | Experimental | Drug: CHOLECALCIFEROL |
| PLACEBO | Placebo comparator | Drug: PLACEBO |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Heart failure diagnosis according to European Society of Cardiology Guideline criteria
- Age > 60 years old
- 25(OH) Vitamin D level < 30 ng/ml
- Clinical and therapeutic stability for one month (NYHA class II or III)
Key exclusion criteria (5 listed)
- Chronic use of anticonvulsants or barbiturates, steroids, thiazides, aluminium or magnesium, colestipol or cholestyramine
- Glomerular filtration rate lower than 30 ml/min/1.73 m2 according to MDRD equation
- Nephrolitiasis, Sarcoidosis or hypercalcemia
- Recent (three months) acute coronary syndrome or stroke or major vascular surgery
- Reduced life expectancy due to other diseases (active neoplasms, liver cirrhosis...)
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 |
|---|---|---|
| CHOLECALCIFEROLAlso: DIBASE (ABIOGEN PHARMA)Standard guideline based therapy plus cholecalciferol: Loading dose 300.000 U then 50.000 U every month for six months | Drug | CHOLECALCIFEROL |
| PLACEBOStandard guideline based therapy plus placebo | Drug | PLACEBO |
Primary outcome
SIX MINUTE WALKING TEST DISTANCE
Time frame: six months
2 secondary outcomes
ECHOCARDIOGRAPHIC PARAMETERS
Time frame: six months
NEUROHORMONAL CHANGES
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
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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.
Fabrizio Turrini, MD principal investigator
Azienda USL di Modena
Marco Bondi, MD study director
Azienda USL di Modena
Paola Loria, MD study chair
Università di Modena
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 CHOLECALCIFEROL in people with Heart Failure and Vitamin D Deficiency, run by Azienda Unita' Sanitaria Locale Di Modena at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 23 Nov 2011. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio Turrini, MD (0039593961100, f.turrini@ausl.mo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIX MINUTE WALKING TEST DISTANCE (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2011.