Diastolic Heart FailureNCT00585611
Effects of Statin Therapy on Vascular Properties and Outcomes in Diastolic Heart Failure Patients
A study testing Atorvastatin in people with Diastolic Heart Failure, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The study is designed to define the underlying vascular abnormalities present in patients with diastolic heart failure and test the effect of a therapy aimed at vascular abnormalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastolic Heart Failure
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jun 2008
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent,
- Age > 18,
- Ejection fraction ≥ 50%,
- hospitalization for heart failure in the last 6 months and
- current NYHA Class II-IV symptoms, OR
- current NYHA Class III-IV symptoms and one of the following:
- ECG or echocardiographic evidence of moderate/severe left ventricular hypertrophy,
- chest x-ray evidence of pulmonary congestion
Who cannot join
- Probable alternative cause of symptoms (pulmonary disease, severe anemia, etc.)
- Prior documented LVEF < 40% or qualitative moderate or greater LV systolic dysfunction.
- Current indication for statin therapy
- Intolerance to statin therapy.
- Documented ischemic heart disease requiring lipid-lowering therapy (i.e. CAD, myocardial infarction, stroke)
- Evidence of significant myocardial ischemia on stress testing at screening visit.
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- Evidence of hepatic abnormality (defined as liver enzymes > 2 times the upper limit of normal values).
- Uncontrolled hypertension (BP > 150/100)
- Significant valvular disease.
- Atrial fibrillation
- Known familial hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy.
- Restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease (i.e. amyloidosis, sarcoidosis, hemochromatosis).
- Cor pulmonale or other cause of right heart failure not related to LV dysfunction.
- Clinically significant pulmonary disease.
- Pericardial constriction or hemodynamically significant pleural effusion.
- Uncontrolled arrhythmia.
- Any systemic condition other than heart failure that may limit survival to less than 2 years.
- Advance renal disease (serum creatinine > 3.0 mg/dl or on dialysis)
- Known intolerance or allergy to HMG CoA reductase inhibitors
- Uncontrolled hyper- or hypothyroidism.
- Any subject characteristic that may interfere with study compliance, such as baseline dementia, substance abuse, history of non-compliance with medications or appointments.
- Prisoners or other vulnerable populations.
- Any woman of child-bearing age with a documented positive pregnancy test.
- Subject is receiving therapy with other investigational therapy or is participating in any other clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
The study is designed to define the underlying vascular abnormalities present in patients with diastolic heart failure and test the effect of a therapy aimed at vascular abnormalities. This study is designed to investigate the effects of therapy with atorvastatin in subjects with diastolic heart failure to improve abnormalities of vascular and myocardial structure and function, with particular emphasis on arterial stiffness and endothelial dysfunction.
Read the detailed description
Forty subjects will be given either drug (atorvastatin 40 mg) or placebo in a randomized fashion once daily for six months. Using echocardiography, tonometry, and flow mediated dilation of conduit arteries and arterioles, baseline cardiovascular anatomy and physiology will be defined. Subjects that enroll in the study will be required to come in for 5 study visits. The initial visit is a screening visit; subject consent is obtained and an echocardiogram is performed as well as blood tests. At the randomization visit (4-14 days following screening), the subject will be provided with drug or placebo in a blinded fashion.Also at this visit, subjects will be asked to do a 6 minute walk, QOL questionnaire, and vascular function testing. There will be follow-up study visits at 1 and 3 months following randomization. At each follow-up visit a medical history, pill count and brief physical examination will be performed, a repeat QOL questionnaire administered, and blood tests to assess safety of the statin therapy. At 6 months, the final study visit will occur. At this visit a full history and detailed physical examination will be performed. Repeat echocardiogram, 6 minute walk test, QOL questionnaire, and vascular function examinations will be performed.
- Conditions
- Diastolic Heart Failure
- Being tested
- Atorvastatin, placebo
- Keywords
- Heart Failure, Congestive
- Medical subject headings
- Heart Failure, Diastolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin - 40 mg orally daily for 6 months
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Heart failure patients assigned to atorvastatin Receives: Drug: Atorvastatin |
| 2 | Placebo comparator | Not described Receives: Drug: Atorvastatin; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Carotid-femoral Pulse Wave Velocity (CFPWV) in the Statin Treated vs. Control Group
Measured: 6 months after initiation of intervention
Secondary outcomes (2)
Composite Cardiovascular Endpoint Incorporating Quality of Life (QOL) Assessment + Hospitalizations for Cardiovascular Disease and Mortality
Measured: 6 months after initiation of intervention
Changes in Submaximal Exercise Capacity Measured by 6-minute Walk Test
Measured: 6 months after initiation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startDec 2005
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Unable to recruit into the study
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.
- Other trials for Diastolic Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy K Sweitzer, MD PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585611
- Sponsor's protocol ID
- H-2005-0430
- Status last verified
- Mar 2019
- First submitted
- 26 Dec 2007
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Statin Therapy on Vascular Properties and Outcomes in Diastolic Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00585611
- Acronym / sponsor ID
- H-2005-0430
- Conditions
- Diastolic Heart Failure
- Keywords
- Heart Failure, Congestive
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit into the study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Jan 2008 (estimated)
- Results
- Posted 26 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to define the underlying vascular abnormalities present in patients with diastolic heart failure and test the effect of a therapy aimed at vascular abnormalities. This study is designed to investigate the effects of therapy with atorvastatin in subjects with diastolic heart failure to improve abnormalities of vascular and myocardial structure and function, with particular emphasis on arterial stiffness and endothelial dysfunction.
Detailed description
Forty subjects will be given either drug (atorvastatin 40 mg) or placebo in a randomized fashion once daily for six months. Using echocardiography, tonometry, and flow mediated dilation of conduit arteries and arterioles, baseline cardiovascular anatomy and physiology will be defined. Subjects that enroll in the study will be required to come in for 5 study visits. The initial visit is a screening visit; subject consent is obtained and an echocardiogram is performed as well as blood tests. At the randomization visit (4-14 days following screening), the subject will be provided with drug or placebo in a blinded fashion.Also at this visit, subjects will be asked to do a 6 minute walk, QOL questionnaire, and vascular function testing. There will be follow-up study visits at 1 and 3 months following randomization. At each follow-up visit a medical history, pill count and brief physical examination will be performed, a repeat QOL questionnaire administered, and blood tests to assess safety of the statin therapy. At 6 months, the final study visit will occur. At this visit a full history and detailed physical examination will be performed. Repeat echocardiogram, 6 minute walk test, QOL questionnaire, and vascular function examinations will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: AtorvastatinHeart failure patients assigned to atorvastatin |
| 2 | Placebo comparator | Drug: Atorvastatin, Other: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent,
- Age > 18,
- Ejection fraction ≥ 50%,
- hospitalization for heart failure in the last 6 months and
- current NYHA Class II-IV symptoms, OR
Key exclusion criteria (24 listed)
- Probable alternative cause of symptoms (pulmonary disease, severe anemia, etc.)
- Prior documented LVEF < 40% or qualitative moderate or greater LV systolic dysfunction.
- Current indication for statin therapy
- Intolerance to statin therapy.
- Documented ischemic heart disease requiring lipid-lowering therapy (i.e. CAD, myocardial infarction, stroke)
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 |
|---|---|---|
| AtorvastatinAtorvastatin - 40 mg orally daily for 6 months | Drug | 2, Atorvastatin |
| placeboplacebo | Other | 2 |
Primary outcome
Change in Carotid-femoral Pulse Wave Velocity (CFPWV) in the Statin Treated vs. Control Group
Time frame: 6 months after initiation of intervention
2 secondary outcomes
Composite Cardiovascular Endpoint Incorporating Quality of Life (QOL) Assessment + Hospitalizations for Cardiovascular Disease and Mortality
Time frame: 6 months after initiation of intervention
Changes in Submaximal Exercise Capacity Measured by 6-minute Walk Test
Time frame: 6 months after initiation of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nancy K Sweitzer, MD PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin in people with Diastolic Heart Failure, run by University of Wisconsin, Madison at 1 site in United States.
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 24 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: stopped early, as of the sponsor's last update on 26 Mar 2019. 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 States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2019). 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?
Change in Carotid-femoral Pulse Wave Velocity (CFPWV) in the Statin Treated vs. Control Group (time frame: 6 months after initiation of intervention). 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 26 Mar 2019.