Heart Failure, CongestivePhase 2NCT00285597
Ursodeoxycholic Acid in Chronic Heart Failure
A Phase 2 study testing Ursodeoxycholic Acid in people with Heart Failure, Congestive, run by National Heart and Lung Institute at 1 site in United Kingdom.
Trial summary
This is a double-blind, placebo-controlled, cross-over study evaluating the effects of UDCA on peripheral blood flow and immune function in patients with stable chronic heart failure (CHF). Sixteen patients with CHF will be recruited from the heart failure clinic at the Royal Brompton Hospital. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Ursodeoxycholic Acid
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2004to Jan 2006
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >21 years
- of either sex
- the patient is willing and capable of complying with the requirements of this protocol
- the patient has provided written informed consent
- the patient has clinical evidence of chronic heart failure:
- reduced ejection fraction (≤40%) or left ventricular impairment on echocardiography (LVEDD ≥60mm)
- stable clinical condition and medication for at least 1 month prior to the study (New York Heart Association class II-IV).
- the patient is receiving appropriate conventional medical therapy for heart failure (ACE inhibitor or angiotensin II blocker, diuretics, beta-blocker as indicated and tolerated).
Who cannot join
- congenital heart disease
- any life-threatening disease, other than heart failure
- active malignancy of any type, or history of a malignancy within previous 5 years. Patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years prior to study enrolment are acceptable.
- previous heart transplant
- severe neuro-muscular disease
- history of unstable angina, myocardial infarction or stroke within 3 months prior to the study
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- pregnancy or women of child-bearing age
- treatment with immunosuppressive therapy e.g. steroids for rheumatoid arthritis or obstructive lung disease
- significant renal dysfunction (serum creatinine >250mmol/l), severe liver disease (liver function tests > 3 times normal)
- unable to understand and comply with protocol or to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ursodeoxycholic Acid Therapy in Chronic Heart Failure: A Placebo-controlled Study Evaluating the Effects of Ursodeoxycholic Acid on Peripheral Blood Flow and Immune Function
This is a double-blind, placebo-controlled, cross-over study evaluating the effects of UDCA on peripheral blood flow and immune function in patients with stable chronic heart failure (CHF). Sixteen patients with CHF will be recruited from the heart failure clinic at the Royal Brompton Hospital. Following baseline evaluation, patients will be randomised to receive either placebo or UDCA at a dose of 1000 mg/day for a period of four weeks. They will then undergo repeat evaluation (peripheral blood flow and immune function). A four week washout period will then take place before the patients cross-over to receive the respective other therapy for a further four weeks (i.e. those first receiving placebo will go onto receive UDCA and vice versa). The study will be completed after a total of twelve weeks, with a final assessment (peripheral blood flow and immune function).
- Conditions
- Heart Failure, Congestive
- Being tested
- Ursodeoxycholic Acid
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic AcidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
peripheral blood flow as assessed by venous occlusion plethysmography
Secondary outcomes (4)
peak and resting arm and leg post-ischaemic blood flow as assessed by venous occlusion plethysmography
tumor Necrosis Factor-alpha (TNF), sCD14, soluble TNF-Receptor 1, Lipopolysaccharide levels
cellular immune function
endothelin-1, B type natriuretic peptide, E-selectin plasma levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startMay 2004
- Study completionJan 2006
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 Heart Failure, CongestiveStudies 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
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Heart and Lung Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Falk Pharma GmbH
- Investigators
- Philip A Poole-Wilson, MD, Principal investigator, National Heart and Lung Institute, Dovehouse Street, London SW3 6LY, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285597
- Sponsor's protocol ID
- 02-080
- Status last verified
- Oct 2009
- First submitted
- 31 Jan 2006
- Last updated
- 9 Oct 2009
- Results posted
- No
Publications
von Haehling S, Schefold JC, Jankowska EA, Springer J, Vazir A, Kalra PR, Sandek A, Fauler G, Stojakovic T, Trauner M, Ponikowski P, Volk HD, Doehner W, Coats AJ, Poole-Wilson PA, Anker SD. Ursodeoxycholic acid in patients with chronic heart failure: a double-blind, randomized, placebo-controlled, crossover trial. J Am Coll Cardiol. 2012 Feb 7;59(6):585-92. doi: 10.1016/j.jacc.2011.10.880.
PubMed 22300693
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ursodeoxycholic Acid Therapy in Chronic Heart Failure: A Placebo-controlled Study Evaluating the Effects of Ursodeoxycholic Acid on Peripheral Blood Flow and Immune Function
- ClinicalTrials.gov ID
- NCT00285597
- Acronym / sponsor ID
- 02-080
- Conditions
- Heart Failure, Congestive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- National Heart and Lung InstituteUniversity, hospital or other
- Collaborators
- Dr. Falk Pharma GmbH
- Study start
- May 2004
- Study completion
- Jan 2006
- First posted
- 2 Feb 2006 (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.
This is a double-blind, placebo-controlled, cross-over study evaluating the effects of UDCA on peripheral blood flow and immune function in patients with stable chronic heart failure (CHF). Sixteen patients with CHF will be recruited from the heart failure clinic at the Royal Brompton Hospital. Following baseline evaluation, patients will be randomised to receive either placebo or UDCA at a dose of 1000 mg/day for a period of four weeks. They will then undergo repeat evaluation (peripheral blood flow and immune function). A four week washout period will then take place before the patients cross-over to receive the respective other therapy for a further four weeks (i.e. those first receiving placebo will go onto receive UDCA and vice versa). The study will be completed after a total of twelve weeks, with a final assessment (peripheral blood flow and immune function).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age >21 years
- of either sex
- the patient is willing and capable of complying with the requirements of this protocol
- the patient has provided written informed consent
- the patient has clinical evidence of chronic heart failure:
Key exclusion criteria (10 listed)
- congenital heart disease
- any life-threatening disease, other than heart failure
- active malignancy of any type, or history of a malignancy within previous 5 years. Patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years prior to study enrolment are acceptable.
- previous heart transplant
- severe neuro-muscular disease
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 |
|---|---|---|
| Ursodeoxycholic Acid | Drug | – |
Primary outcome
peripheral blood flow as assessed by venous occlusion plethysmography
4 secondary outcomes
peak and resting arm and leg post-ischaemic blood flow as assessed by venous occlusion plethysmography
tumor Necrosis Factor-alpha (TNF), sCD14, soluble TNF-Receptor 1, Lipopolysaccharide levels
cellular immune function
endothelin-1, B type natriuretic peptide, E-selectin plasma levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2009.
- Derived from this study: PubMed 22300693von Haehling S, Schefold JC, Jankowska EA, Springer J, Vazir A, Kalra PR, Sandek A, Fauler G, Stojakovic T, Trauner M, Ponikowski P, Volk HD, Doehner W, Coats AJ, Poole-Wilson PA, Anker SD. Ursodeoxycholic acid in patients with chronic heart failure: a double-blind, randomized, placebo-controlled, crossover trial. J Am Coll Cardiol. 2012 Feb 7;59(6):585-92. doi: 10.1016/j.jacc.2011.10.880.
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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.
Philip A Poole-Wilson, MD principal investigator
National Heart and Lung Institute, Dovehouse Street, London SW3 6LY, UK
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 Ursodeoxycholic Acid in people with Heart Failure, Congestive, run by National Heart and Lung Institute 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 8 inclusion and 10 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 9 Oct 2009. 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. 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?
Results are not available in the source record.
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?
peripheral blood flow as assessed by venous occlusion plethysmography. 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 NCT00285597, 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 9 Oct 2009.