Heart Failure With Preserved Ejection FractionPhase 3PIE-INCT01411735
Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure
A Phase 3 study testing Enalapril in people with Heart Failure With Preserved Ejection Fraction and Heart Failure, Congestive, run by Wake Forest University.
Trial summary
BACKGROUND: Exercise intolerance is the primary symptom in older patients with heart failure and preserved ejection fraction (HFPEF), however little is known regarding its mechanisms and therapy. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Heart Failure, Congestive
- What is being tested?
- Enalapril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Jul 2008
- Phase
- Phase 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
- All participants will be 60 years of age or older.
Who cannot join
- systolic dysfunction
- patients with evidence of significant ischemic or valvular heart disease
- chronic pulmonary disease.
- Participants who appear preliminarily eligible are invited to a formal screening visiting with an investigator cardiology physician. They also undergoing a rest and exercise electrocardiogram and echocardiogram and pulmonary function testing as well as blood hematology and chemistry tests.
- Final eligibility will be based upon all information available at the conclusion of the screening visits test, including hospital and outpatient records, history, physical examination, echocardiogram and exercise test.
About this study
BACKGROUND: Exercise intolerance is the primary symptom in older patients with heart failure and preserved ejection fraction (HFPEF), however little is known regarding its mechanisms and therapy.
METHODS: 71 elderly stable, compensated HFPEF patients (age 70+1 years; 80% women) with controlled blood pressure were randomized into a 12 month follow-up (FU) double-blind trial of enalapril 20 mg per day (E) vs. placebo (P). Assessments included: peak exercise oxygen consumption (VO2); six-minute walk test; Minnesota Living with HF Questionnaire (MLHF); MRI; Doppler-echocardiography; and vascular ultrasound.
- Being tested
- Enalapril, placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnalaprilDrug
2.5mg titrated up to 10mg twice daily
placeboDrug
2.5mg titrated up to 10mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Enalapril | Active comparator | 2.5mg titrated up to 10mg- twice daily Receives: Drug: Enalapril |
| placebo | Placebo comparator | 2.5 mg titrate up to 10mg twice daily placebo comparator Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity and aortic distensibility
MRI and expired gas analysis
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startJul 2003
- Primary completionJun 2004
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dalane W Kitzman, MD, Principal investigator, Professor of Medicine-Cardiology Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411735
- Sponsor's protocol ID
- R01AG018915-01
- Acronym
- PIE-I
- Status last verified
- Aug 2011
- First submitted
- 5 Aug 2011
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure
- ClinicalTrials.gov ID
- NCT01411735
- Acronym / sponsor ID
- PIE-I / R01AG018915-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 8 Aug 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.
BACKGROUND: Exercise intolerance is the primary symptom in older patients with heart failure and preserved ejection fraction (HFPEF), however little is known regarding its mechanisms and therapy.
METHODS: 71 elderly stable, compensated HFPEF patients (age 70+1 years; 80% women) with controlled blood pressure were randomized into a 12 month follow-up (FU) double-blind trial of enalapril 20 mg per day (E) vs. placebo (P). Assessments included: peak exercise oxygen consumption (VO2); six-minute walk test; Minnesota Living with HF Questionnaire (MLHF); MRI; Doppler-echocardiography; and vascular ultrasound.
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 |
|---|---|---|
| Enalapril | Active comparator | Drug: Enalapril2.5mg titrated up to 10mg- twice daily |
| placebo | Placebo comparator | Drug: placebo2.5 mg titrate up to 10mg twice daily placebo comparator |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants will be 60 years of age or older.
Key exclusion criteria (5 listed)
- systolic dysfunction
- patients with evidence of significant ischemic or valvular heart disease
- chronic pulmonary disease.
- Participants who appear preliminarily eligible are invited to a formal screening visiting with an investigator cardiology physician. They also undergoing a rest and exercise electrocardiogram and echocardiogram and pulmonary function testing as well as blood hematology and chemistry tests.
- Final eligibility will be based upon all information available at the conclusion of the screening visits test, including hospital and outpatient records, history, physical examination, echocardiogram and exercise test.
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 |
|---|---|---|
| Enalapril2.5mg titrated up to 10mg twice daily | Drug | Enalapril |
| placebo2.5mg titrated up to 10mg twice daily. | Drug | placebo |
Primary outcome
exercise capacity and aortic distensibility
Time frame: 9 months
MRI and expired gas analysis
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 6 Nov 2017.
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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.
Dalane W Kitzman, MD principal investigator
Professor of Medicine-Cardiology Section
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enalapril in people with Heart Failure With Preserved Ejection Fraction and Heart Failure, Congestive, run by Wake Forest University.
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 1 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: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
exercise capacity and aortic distensibility (time frame: 9 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 6 Nov 2017.