Heart Failure, DiastolicTREND-HFNCT02155842
Exercise Training in Treating Diastolic Heart Failure
A study testing High intensity endurance exercise and Moderate continuous endurance exercise in people with Heart Failure, Diastolic and Ventricular Dysfunction, Left, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether endurance exercise of either high or moderate intensity can reverse structural and functional changes of the heart in patients with diastolic heart failure, and to investigate which type of exercise is best in terms of aerobe capacity and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diastolic, Ventricular Dysfunction, Left
- What is being tested?
- High intensity endurance exercise and Moderate continuous endurance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2014to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedentary lifestyle
- Normal systolic function left ventricular ejection fraction (LVEF) < 50%
- New York Heart Association (NYHA) class II or III
- Diastolic dysfunction (E/é < 15 or E/é 8-15 and N-terminal proBNP > 220pg/ml)
- Medically stable the last 4 weeks
- Written informed consent
Who cannot join
- Other causes of dyspnea than diastolic heart failure
- Personal preferences or characteristics prohibiting the person from attending inpatient cardiac rehabilitation
- Not able to perform physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Versus Moderate Intensity Endurance Exercise Training in Treating Diastolic Heart Failure
The purpose of this study is to determine whether endurance exercise of either high or moderate intensity can reverse structural and functional changes of the heart in patients with diastolic heart failure, and to investigate which type of exercise is best in terms of aerobe capacity and quality of life.
The investigators expect that high intensity endurance exercise is superior to moderate intensity endurance exercise.
Read the detailed description
This study is a prospective randomized controlled intervention study comparing two active arms. Eligible patients are being sampled consecutively by cardiologists, and randomized to either high or moderate intensity endurance exercise. Endpoints are measured at baseline, 4 weeks and 7 months. The intervention is considered safe, and the study has been approved by the Regional Ethics Committee (REK-midt).
This project has been financially supported by the Norwegian ExtraFoundation for Health and Rehabilitation through EXTRA funds.
- Being tested
- High intensity endurance exercise, Moderate continuous endurance exercise
- Keywords
- exercise therapy
- Medical subject headings
- Heart Failure, Diastolic, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity endurance exerciseBehavioural
Moderate continuous endurance exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| High intensity endurance exercise | Experimental | Four weeks comprehensive cardiac rehabilitation with moderate volume high intensity endurance exercise, followed by 6 months non-supervised endurance exercise Receives: Behavioral: High intensity endurance exercise |
| Moderate continuous endurance exercise | Active comparator | Four weeks comprehensive cardiac rehabilitation with moderate volume moderate intensity endurance exercise, followed by 6 months non-supervised endurance exercise Receives: Behavioral: Moderate continuous endurance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aerobic capacity measured as oxygen consumption
Cardiopulmonary exercise test
Measured: Baseline and 7 months
Secondary outcomes (7)
Feasibility, measured as attrition rate and compliance with exercise
Measured: Baseline to 7 months
Blood-risk profile, measured as changes in cholesterol, hemoglobin, N terminal-proBNP
Measured: Baseline to 7 months
Cardiac function measured as volume, size, efficacy
Ultrasound
Measured: Baseline to 7 months
Arterial function measured as blood-vessel elasticity
Ultrasound
Measured: Baseline to 7 months
Quality of life
Self-reported questionnaires
Measured: Baseline to 7 months
Changes in everyday activity level
Self-reported questionnaire, diary, activity monitoring device
Measured: Baseline to 7 months
Change in diastolic filling pressure measured as E/é
Ultrasound
Measured: Baseline to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015 (estimated)
Why it stopped: Unforseen problems recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- LHL-Klinikkene, Røros, LHL-Klinikkene, Feiring
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisløff, phd prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155842
- Sponsor's protocol ID
- 2014.12327
- Other IDs
- 2014
- Acronym
- TREND-HF
- Status last verified
- Mar 2016
- First submitted
- 27 May 2014
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Versus Moderate Intensity Endurance Exercise Training in Treating Diastolic Heart Failure
- ClinicalTrials.gov ID
- NCT02155842
- Acronym / sponsor ID
- TREND-HF / 2014.12327
- Keywords
- exercise therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unforseen problems recruiting patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- LHL-Klinikkene, Røros, LHL-Klinikkene, Feiring
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 4 Jun 2014 (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 endurance exercise of either high or moderate intensity can reverse structural and functional changes of the heart in patients with diastolic heart failure, and to investigate which type of exercise is best in terms of aerobe capacity and quality of life.
The investigators expect that high intensity endurance exercise is superior to moderate intensity endurance exercise.
Detailed description
This study is a prospective randomized controlled intervention study comparing two active arms. Eligible patients are being sampled consecutively by cardiologists, and randomized to either high or moderate intensity endurance exercise. Endpoints are measured at baseline, 4 weeks and 7 months. The intervention is considered safe, and the study has been approved by the Regional Ethics Committee (REK-midt).
This project has been financially supported by the Norwegian ExtraFoundation for Health and Rehabilitation through EXTRA funds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity endurance exercise | Experimental | Behavioral: High intensity endurance exerciseFour weeks comprehensive cardiac rehabilitation with moderate volume high intensity endurance exercise, followed by 6 months non-supervised endurance exercise |
| Moderate continuous endurance exercise | Active comparator | Behavioral: Moderate continuous endurance exerciseFour weeks comprehensive cardiac rehabilitation with moderate volume moderate intensity endurance exercise, followed by 6 months non-supervised endurance exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sedentary lifestyle
- Normal systolic function left ventricular ejection fraction (LVEF) < 50%
- New York Heart Association (NYHA) class II or III
- Diastolic dysfunction (E/é < 15 or E/é 8-15 and N-terminal proBNP > 220pg/ml)
- Medically stable the last 4 weeks
Key exclusion criteria (3 listed)
- Other causes of dyspnea than diastolic heart failure
- Personal preferences or characteristics prohibiting the person from attending inpatient cardiac rehabilitation
- Not able to perform physical exercise
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 |
|---|---|---|
| High intensity endurance exercise | Behavioural | High intensity endurance exercise |
| Moderate continuous endurance exercise | Behavioural | Moderate continuous endurance exercise |
Primary outcome
Change in aerobic capacity measured as oxygen consumption
Time frame: Baseline and 7 months
Cardiopulmonary exercise test
7 secondary outcomes
Feasibility, measured as attrition rate and compliance with exercise
Time frame: Baseline to 7 months
Blood-risk profile, measured as changes in cholesterol, hemoglobin, N terminal-proBNP
Time frame: Baseline to 7 months
Cardiac function measured as volume, size, efficacy
Time frame: Baseline to 7 months
Arterial function measured as blood-vessel elasticity
Time frame: Baseline to 7 months
Quality of life
Time frame: Baseline to 7 months
Changes in everyday activity level
Time frame: Baseline to 7 months
Change in diastolic filling pressure measured as E/é
Time frame: Baseline to 7 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Ulrik Wisløff, phd prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity endurance exercise and Moderate continuous endurance exercise in people with Heart Failure, Diastolic and Ventricular Dysfunction, Left, run by Norwegian University of Science and Technology at 1 site in Norway.
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 6 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: withdrawn, as of the sponsor's last update on 30 Mar 2016. 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 Norway. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 aerobic capacity measured as oxygen consumption (time frame: Baseline and 7 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 30 Mar 2016.