Cardiac RehabilitationNCT03178357
"Cardiac Rehabilitation in Patients With Hypertrophic Cardiomyopathy".
A study testing Cardiac rehabilitation + standard therapy and Standard therapy in people with Cardiac Rehabilitation, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
Hypertrophic cardiomyopathy (HCM) is the most common hereditary disease characterized by left ventricular hypertrophy and consequently left ventricular diastolic dysfunction. Its prevalence is estimated at around 0.2% in the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Cardiac rehabilitation + standard therapy and Standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jul 2017to Dec 2020
- 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
- Patient with hypertrophic cardiomyopathy (defined in accordance with the ESC guidelines for the diagnosis and management of cardiomyopathy and hypertrophy in 2014): thickness ≥ 15 mm of one or more segments of the left ventricular wall measured using any imaging technique [echocardiography, cardiac magnetic resonance or computed tomography] which can not be explained solely by the left ventricular loading conditions) without left ventricular outflow tract obstruction at rest: gradient <30 mmHg.
- Stable general condition (1 month period).
- NYHA Class II and III.
- Preserved LV systolic function (LVEF ≥ 50%).
- Condition after ICD implantation.
- Written informed consent of the patient to participate in the Program.
- Completed eighteen years of age.
Who cannot join
- Complex life-threatening ventricular arrhythmias that can not be treated.
- Uncontrolled hypertension.
- Advanced atrio-ventricular block.
- Myocarditis or pericarditis (up to 6 months).
- Symptomatic aortic stenosis.
- Acute systemic illness.
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- Intracardiac thrombosis.
- Significant ischaemia during low intensity exercise test (2 METS, 50W).
- Uncontrolled diabetes.
- Pulmonary embolism (up to 6 months).
- Thrombophlebitis.
- New episode of AF/Afl.
- Decrease in systolic blood pressure during exercise.
- Co-morbidities that limit exercise tolerance and prevent exercise.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, Masovian Voivodeship, 04-628
Krzysztof R Sadowski, MD, +483434408, ksadowski@ikard.pl
Krzysztof Sadowski, MD
About this study
Official title: "Efficacy and Safety of Cardiac Rehabilitation in Patients With Hypertrophic Cardiomyopathy Without Left Ventricular Outflow Tract Obstruction With Preserved Systolic Function - Pilot Study".
Hypertrophic cardiomyopathy (HCM) is the most common hereditary disease characterized by left ventricular hypertrophy and consequently left ventricular diastolic dysfunction. Its prevalence is estimated at around 0.2% in the general population. HCM is the most common cause of sudden cardiac death due to cardiovascular disease in young athletes, accounting for one third of deaths. HCM patients often have symptoms of heart failure. The ESC recommendations for heart failure (HF) from 2016 recommend exercise training regardless of ejection fraction to improve exercise capacity, quality of life, and reduction in hospitalizations due to HF. Meanwhile, for many years, HCM was equivalent to exercise training limitation. According to the 2014 ESC guidelines, it is recommended for patients with HCM to avoid sports practice. However the results of Edelmann et al. research, suggest that physical training leads to a significant clinical improvement in patients with diastolic dysfunction and thus may be beneficial in patients with HCM. In 2015 results of a first study were published (Klempfner et al.), which showed that the majority of HCM patients with moderate risk undergoing supervised physical training had improved physical performance and no significant adverse events were recorded. The study was limited by the small number of admitted patients (twenty), lack of control group and failure to perform cardio-pulmonary exercise test.
The main goal of the study will be to evaluate the effectiveness and safety of comprehensive cardiological rehabilitation and telerehabilitation in patients with hypertrophic cardiomyopathy without left ventricular outflow tract obstruction with preserved systolic function. The study is planned to include 30 patients with HCM subjected to physical training and 30 patients with HCM in the control group treated as standard according to current guidelines, not subjected to physical training.
Read the detailed description
The main goal of the study will be to evaluate the effectiveness and safety of comprehensive cardiological rehabilitation and telerehabilitation in patients with hypertrophic cardiomyopathy without left ventricular outflow tract obstruction with preserved systolic function. The study is planned to include 30 patients with HCM subjected to physical training and 30 patients with HCM in the control group treated as standard according to current guidelines, not subjected to physical training.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Cardiac rehabilitation + standard therapy, Standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitation + standard therapyOther
Also called Standard therapy
Patients with HCM subjected to cardiological rehabilitation
Standard therapyOther
Standard treatment according to current guidelines and outpatient visits with psychological and / or psychoeducational counseling
| Study group | Role | What they receive |
|---|---|---|
| HCM patients with CR | Other | 30 HCM patients treated as standard subjected to 4-week hospital cardiac rehabilitation (CR) including psychological care (counseling and / or psychoeducation) and physical training followed by 8 weeks of telerehabilitation in the patient's home (cardiac rehabilitation + standard therapy) Receives: Other: Cardiac rehabilitation + standard therapy |
| HCM patients without CR (control group) | Other | 30 HCM patients in control group - standard treatment according to current guidelines and outpatient visits with psychological and / or psychoeducational counseling (standard therapy) Receives: Other: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak VO2
Physical efficiency evaluated in the measurable parameter - peak VO2.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start10 Jul 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krzysztof Sadowski, Principal investigator, The Cardinal Stefan Wyszyński Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178357
- Sponsor's protocol ID
- 2.1/I/17
- Status last verified
- Mar 2019
- First submitted
- 5 Jun 2017
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- "Efficacy and Safety of Cardiac Rehabilitation in Patients With Hypertrophic Cardiomyopathy Without Left Ventricular Outflow Tract Obstruction With Preserved Systolic Function - Pilot Study".
- ClinicalTrials.gov ID
- NCT03178357
- Acronym / sponsor ID
- 2.1/I/17
- Conditions
- Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Jun 2017 (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.
Hypertrophic cardiomyopathy (HCM) is the most common hereditary disease characterized by left ventricular hypertrophy and consequently left ventricular diastolic dysfunction. Its prevalence is estimated at around 0.2% in the general population. HCM is the most common cause of sudden cardiac death due to cardiovascular disease in young athletes, accounting for one third of deaths. HCM patients often have symptoms of heart failure. The ESC recommendations for heart failure (HF) from 2016 recommend exercise training regardless of ejection fraction to improve exercise capacity, quality of life, and reduction in hospitalizations due to HF. Meanwhile, for many years, HCM was equivalent to exercise training limitation. According to the 2014 ESC guidelines, it is recommended for patients with HCM to avoid sports practice. However the results of Edelmann et al. research, suggest that physical training leads to a significant clinical improvement in patients with diastolic dysfunction and thus may be beneficial in patients with HCM. In 2015 results of a first study were published (Klempfner et al.), which showed that the majority of HCM patients with moderate risk undergoing supervised physical training had improved physical performance and no significant adverse events were recorded. The study was limited by the small number of admitted patients (twenty), lack of control group and failure to perform cardio-pulmonary exercise test.
The main goal of the study will be to evaluate the effectiveness and safety of comprehensive cardiological rehabilitation and telerehabilitation in patients with hypertrophic cardiomyopathy without left ventricular outflow tract obstruction with preserved systolic function. The study is planned to include 30 patients with HCM subjected to physical training and 30 patients with HCM in the control group treated as standard according to current guidelines, not subjected to physical training.
Detailed description
The main goal of the study will be to evaluate the effectiveness and safety of comprehensive cardiological rehabilitation and telerehabilitation in patients with hypertrophic cardiomyopathy without left ventricular outflow tract obstruction with preserved systolic function. The study is planned to include 30 patients with HCM subjected to physical training and 30 patients with HCM in the control group treated as standard according to current guidelines, not subjected to physical training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCM patients with CR | Other | Other: Cardiac rehabilitation + standard therapy30 HCM patients treated as standard subjected to 4-week hospital cardiac rehabilitation (CR) including psychological care (counseling and / or psychoeducation) and physical training followed by 8 weeks of telerehabilitation in the patient's home (cardiac rehabilitation + standard therapy) |
| HCM patients without CR (control group) | Other | Other: Standard therapy30 HCM patients in control group - standard treatment according to current guidelines and outpatient visits with psychological and / or psychoeducational counseling (standard therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with hypertrophic cardiomyopathy (defined in accordance with the ESC guidelines for the diagnosis and management of cardiomyopathy and hypertrophy in 2014): thickness ≥ 15 mm of one or more segments of the left ventricular wall measured using any imaging technique [echocardiography, cardiac magnetic resonance or computed tomography] which can not be explained solely by the left ventricular loading conditions) without left ventricular outflow tract obstruction at rest: gradient <30 mmHg.
- Stable general condition (1 month period).
- NYHA Class II and III.
- Preserved LV systolic function (LVEF ≥ 50%).
- Condition after ICD implantation.
Key exclusion criteria (14 listed)
- Complex life-threatening ventricular arrhythmias that can not be treated.
- Uncontrolled hypertension.
- Advanced atrio-ventricular block.
- Myocarditis or pericarditis (up to 6 months).
- Symptomatic aortic stenosis.
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 |
|---|---|---|
| Cardiac rehabilitation + standard therapyAlso: Standard therapyPatients with HCM subjected to cardiological rehabilitation | Other | HCM patients with CR |
| Standard therapyStandard treatment according to current guidelines and outpatient visits with psychological and / or psychoeducational counseling | Other | HCM patients without CR (control group) |
Primary outcome
Peak VO2
Time frame: 36 months
Physical efficiency evaluated in the measurable parameter - peak VO2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- 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.
Krzysztof Sadowski principal investigator
The Cardinal Stefan Wyszyński Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation + standard therapy and Standard therapy in people with Cardiac Rehabilitation, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 7 inclusion and 14 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 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 Poland. 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 Krzysztof R Sadowski, MD (+48223434408, ksadowski@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak VO2 (time frame: 36 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 26 Mar 2019.