Heart Failure With Preserved Ejection FractionNCT01288365
The Impact of Exercise Training on Functional Capacity in Heart Failure
A study testing Exercise training in people with Heart Failure With Preserved Ejection Fraction, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether exercise training will improve functional capacity in patients with heart failure and preserved ejection fraction. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Jun 2013
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical heart failure
- Preserved ejection fraction (>50%)
- Stable clinically
- New York Heart Association Class II-III
Who cannot join
- Unable to exercise
- Other debilitating or unstable disease limiting length of life
- Implanted pacemaker
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah University Hospital
Jerusalem, IL-91120
Meirav Miara, MA, 972-2-6776564, JRmeiravM@clalit.org.il
Israel Gotsman, MD
About this study
Official title: Impact of Exercise Training on Functional Capacity in Heart Failure Patients With Preserved Ejection Fraction.
The purpose of this study is to determine whether exercise training will improve functional capacity in patients with heart failure and preserved ejection fraction.
- Being tested
- Exercise training
- Keywords
- heart failure, preserved ejection fraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Exercise training program for 3 months (two times a week).
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Protocol of 3 month exercise training program. Receives: Behavioral: Exercise training |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of peak oxygen uptake on graded exercise.
Changes in physical fitness after 3 month exercise training. This will be measured by a cardiopulmonary exercise test with recording of maximal oxygen uptake during incremental exercise.
Measured: After 3 month exercise training
Secondary outcomes (2)
Change from baseline of six minute walk
Change in the distance covered during a 6 minute walk after 3 month exercise training.
Measured: After 3 month exercise training
Change from baseline of NYHA class
Change in subjective assessment of function capacity based on the New York Heart Association Class classification after 3 month exercise training.
Measured: After 3 month exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services, Hadassah Medical Organization
- Responsible party
- Sponsor
- Investigators
- Israel Gotsman, MD, Principal investigator, Hadassah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288365
- Sponsor's protocol ID
- MeirMc K015/2011
- Status last verified
- Mar 2012
- First submitted
- 26 Jan 2011
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise Training on Functional Capacity in Heart Failure Patients With Preserved Ejection Fraction.
- ClinicalTrials.gov ID
- NCT01288365
- Acronym / sponsor ID
- MeirMc K015/2011
- Keywords
- heart failure, preserved ejection fraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Clalit Health Services, Hadassah Medical Organization
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 2 Feb 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 exercise training will improve functional capacity in patients with heart failure and preserved ejection fraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: Exercise trainingProtocol of 3 month exercise training program. |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical heart failure
- Preserved ejection fraction (>50%)
- Stable clinically
- New York Heart Association Class II-III
Key exclusion criteria (3 listed)
- Unable to exercise
- Other debilitating or unstable disease limiting length of life
- Implanted pacemaker
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 |
|---|---|---|
| Exercise trainingExercise training program for 3 months (two times a week). | Behavioural | Exercise training |
Primary outcome
Change from baseline of peak oxygen uptake on graded exercise.
Time frame: After 3 month exercise training
Changes in physical fitness after 3 month exercise training. This will be measured by a cardiopulmonary exercise test with recording of maximal oxygen uptake during incremental exercise.
2 secondary outcomes
Change from baseline of six minute walk
Time frame: After 3 month exercise training
Change from baseline of NYHA class
Time frame: After 3 month exercise training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
Related trials for Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
ELEVATE-HFpEF Clinical Study
Heart Failure With Preserved Ejection Fraction (HFpEF)
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.
Israel Gotsman, MD principal investigator
Hadassah University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Heart Failure With Preserved Ejection Fraction, run by Meir Medical Center at 1 site in Israel.
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 3 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 19 Mar 2012. 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 Israel. 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.
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 Meirav Miara, MA (972-2-6776564, JRmeiravM@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of peak oxygen uptake on graded exercise. (time frame: After 3 month exercise training). 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 19 Mar 2012.