Hypertrophic CardiomyopathyWEDGE-HCMNCT03537183
Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy?
A study testing Exercise training in people with Hypertrophic Cardiomyopathy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Aims and objectives: The primary objective of this study is to assess whether a structured exercise program improves cardiac relaxing properties in patients with hypertrophic cardiomyopathy (HCM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2018to 1 Apr 2023
- 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
- ≥18 years at the time of screening
- Documented phenotypic HCM (maximal wall thickness ≥15mm, or ≥13mm in a first degree relative with a definite or likely disease causing genetic mutation (appendix 1)
- Not exercising regularly (dedicated moderate or high-intensity exercise >1 hour weekly)
- NYHA class I-IV.
Who cannot join
- Phenocopies (i.e. syndromes, metabolic disorders (appendix 2))
- A history of exercise induced syncope within the last year, severe angina (CCS III-IV), hemodynamically severe valvular disorders
- Scheduled septal reduction therapy, less than 3 months after septal reduction therapy or known LVOT gradient above 30 mmHg at rest
- Severe hypertension (Systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg).
- Inability to exercise due to orthopedic or other non-cardiovascular limitations.
- Pregnancy
- Changes in medication that may affect exercise capacity and/or hemodynamics (i.e. beta blockers and calcium channel blockers)
- Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy? - A Randomized Clinical Trial
Aims and objectives: The primary objective of this study is to assess whether a structured exercise program improves cardiac relaxing properties in patients with hypertrophic cardiomyopathy (HCM).
Background: HCM is a hereditary disease in which the myocardium becomes thickened without an identifiable cause (other than genetic). It is the most common genetic cardiovascular disease with an estimated prevalence of 1/500 (i.e. 10.000 affected individuals in Denmark). The majority of patients with HCM suffers from shortness of breath and reduced exercise capacity due to increased left ventricular (LV) stiffness. Exercise training has been shown to improve exercise capacity and symptoms in patients with HCM, but the mechanisms responsible for this improvement are not known.
Read more
Methods and materials: The study is a randomized, single blinded, prospective, controlled clinical trial. Eighty patients are recruited from outpatient clinics in the Capital Region of Denmark. Patients are randomized in a 1:1 ratio to 12 week of moderate-intensity exercise training or usual activity level. Assessments will include right heart catheterization, echocardiography, cardiopulmonary exercise testing, blood-samples, quality of life, and, in a subgroup of patients, cardiac magnetic resonance imaging. The primary end-point is change in LV filling pressure assessed as pulmonary capillary wedge pressure at 25 W workload.
Expected outcome and perspectives: The investigators hypothesize that an exercise training program will reduce cardiac stiffness and improve symptoms in patients with HCM. Training of HCM patients has long been debated and the topic is poorly researched. The effects of exercise on hemodynamics in HCM patients are unknown and a better understanding of these mechanisms is pivotal for improving treatment.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Exercise training
- Keywords
- hypertrophic cardiomyopathy, exercise training, PCWP
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
12 weeks, 3 hours a week, moderate intensity exercise training
| Study group | Role | What they receive |
|---|---|---|
| Usual activity level | No intervention | 12 weeks of usual activity level |
| Exercise training | Active comparator | 12 weeks of moderate intensity exercise training, 3 hours a week Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to follow-up in PCWP at 25 W
Pulmonary capillary wedge pressure (mmHg)
Measured: 12 weeks
Secondary outcomes (13)
Pulmonary capillary wedge pressure
At rest, at 25% and 50% of the maximum workload and at maximum workload ( measured as mmHg)
Measured: 12 weeks
Workload adjusted Pulmonary capillary wedge pressure
At rest, at 25% and 50% of the maximum workload and at maximum workload, measured as mmHg/kg/W
Measured: 12 weeks
Systemic vascular resistance
Resting and exercise systemic vascular resistance at rest, 25 W, 25% and 50% of the maximum workload and at maximum workload ( measured as mmHg)
Measured: 12 weeks
Exercise capacity
Measured as watt at maximum workload
Measured: 12 weeks
Heart rate
At rest, during exercise and at maximum exercise capacity (beats/min)
Measured: 12 weeks
Blood pressure
At rest, at maximum workload, 6 minutes after cease of workload (mmHg)
Measured: 12 weeks
Cardiac index
At rest, 25W and at maximum workload (L/min/m2):
Measured: 12 weeks
Arterio-venous difference
At rest, 25W and at maximum workload (ml O2/L)and workload corrected (mlO2/L/W)
Measured: 12 weeks
VO2 max
Measered as ml O2/min/kg
Measured: 12 weeks
Quality of life questionnaire
Measured by Kansas City Cardiomyopathy score
Measured: 12 weeks
NT-Pro-BNP
(pmol/L)
Measured: 12 weeks
Troponin-T
(mmol/L)
Measured: 12 weeks
Echocardiographic parameters
At rest: E/e'-ratio, E/A-ratio, deceleration time, LVOT gradient (mmHg). During exercise from 25W to maximum workload: E/e'-ratio, E/A-ratio, deceleration time, LVOT gradient(mmHg).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start1 Sep 2018
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
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 Hypertrophic CardiomyopathyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Helga Gudmundsdottir, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537183
- Sponsor's protocol ID
- 63446
- Acronym
- WEDGE-HCM
- Status last verified
- Apr 2023
- First submitted
- 9 May 2018
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gudmundsdottir HL, Axelsson Raja A, Rossing K, Rasmusen H, Snoer M, Andersen LJ, Gottlieb R, Christensen AH, Bundgaard H, Gustafsson F, Thune JJ. Exercise Training in Patients With Hypertrophic Cardiomyopathy Without Left Ventricular Outflow Tract Obstruction: A Randomized Clinical Trial. Circulation. 2025 Jan 14;151(2):132-144. doi: 10.1161/CIRCULATIONAHA.124.070064. Epub 2024 Nov 8.
PubMed 39513255
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy? - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03537183
- Acronym / sponsor ID
- WEDGE-HCM / 63446
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- hypertrophic cardiomyopathy, exercise training, PCWP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 25 May 2018 (actual)
- 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.
Aims and objectives: The primary objective of this study is to assess whether a structured exercise program improves cardiac relaxing properties in patients with hypertrophic cardiomyopathy (HCM).
Background: HCM is a hereditary disease in which the myocardium becomes thickened without an identifiable cause (other than genetic). It is the most common genetic cardiovascular disease with an estimated prevalence of 1/500 (i.e. 10.000 affected individuals in Denmark). The majority of patients with HCM suffers from shortness of breath and reduced exercise capacity due to increased left ventricular (LV) stiffness. Exercise training has been shown to improve exercise capacity and symptoms in patients with HCM, but the mechanisms responsible for this improvement are not known.
Methods and materials: The study is a randomized, single blinded, prospective, controlled clinical trial. Eighty patients are recruited from outpatient clinics in the Capital Region of Denmark. Patients are randomized in a 1:1 ratio to 12 week of moderate-intensity exercise training or usual activity level. Assessments will include right heart catheterization, echocardiography, cardiopulmonary exercise testing, blood-samples, quality of life, and, in a subgroup of patients, cardiac magnetic resonance imaging. The primary end-point is change in LV filling pressure assessed as pulmonary capillary wedge pressure at 25 W workload.
Expected outcome and perspectives: The investigators hypothesize that an exercise training program will reduce cardiac stiffness and improve symptoms in patients with HCM. Training of HCM patients has long been debated and the topic is poorly researched. The effects of exercise on hemodynamics in HCM patients are unknown and a better understanding of these mechanisms is pivotal for improving treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual activity level | No intervention | –12 weeks of usual activity level |
| Exercise training | Active comparator | Other: Exercise training12 weeks of moderate intensity exercise training, 3 hours a week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years at the time of screening
- Documented phenotypic HCM (maximal wall thickness ≥15mm, or ≥13mm in a first degree relative with a definite or likely disease causing genetic mutation (appendix 1)
- Not exercising regularly (dedicated moderate or high-intensity exercise >1 hour weekly)
- NYHA class I-IV.
Key exclusion criteria (8 listed)
- Phenocopies (i.e. syndromes, metabolic disorders (appendix 2))
- A history of exercise induced syncope within the last year, severe angina (CCS III-IV), hemodynamically severe valvular disorders
- Scheduled septal reduction therapy, less than 3 months after septal reduction therapy or known LVOT gradient above 30 mmHg at rest
- Severe hypertension (Systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg).
- Inability to exercise due to orthopedic or other non-cardiovascular limitations.
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 training12 weeks, 3 hours a week, moderate intensity exercise training | Other | Exercise training |
Primary outcome
Change from baseline to follow-up in PCWP at 25 W
Time frame: 12 weeks
Pulmonary capillary wedge pressure (mmHg)
13 secondary outcomes
Pulmonary capillary wedge pressure
Time frame: 12 weeks
Workload adjusted Pulmonary capillary wedge pressure
Time frame: 12 weeks
Systemic vascular resistance
Time frame: 12 weeks
Exercise capacity
Time frame: 12 weeks
Heart rate
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Cardiac index
Time frame: 12 weeks
Arterio-venous difference
Time frame: 12 weeks
VO2 max
Time frame: 12 weeks
Quality of life questionnaire
Time frame: 12 weeks
NT-Pro-BNP
Time frame: 12 weeks
Troponin-T
Time frame: 12 weeks
Echocardiographic parameters
Time frame: 12 weeks
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 1 May 2023.
- Derived from this study: PubMed 39513255Gudmundsdottir HL, Axelsson Raja A, Rossing K, Rasmusen H, Snoer M, Andersen LJ, Gottlieb R, Christensen AH, Bundgaard H, Gustafsson F, Thune JJ. Exercise Training in Patients With Hypertrophic Cardiomyopathy Without Left Ventricular Outflow Tract Obstruction: A Randomized Clinical Trial. Circulation. 2025 Jan 14;151(2):132-144. doi: 10.1161/CIRCULATIONAHA.124.070064. Epub 2024 Nov 8.
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A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
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Human Experimental Models of Pain (HEMP)
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A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertrophic Cardiomyopathy, run by Bispebjerg Hospital at 1 site in Denmark.
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 8 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 1 May 2023. 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 Denmark. 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 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?
Change from baseline to follow-up in PCWP at 25 W (time frame: 12 weeks). 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 NCT03537183, 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 1 May 2023.