Heart Failure PatientsCAST-HFNCT03859466
Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting
A study testing Shockwave Therapy in people with Heart Failure Patients and Cardiac Ischemia, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
This randomised, controlled clinical trial aims to evaluate the safety and efficacy of Cardiac Shockwave Therapy (CAST-HF) in patients with ischaemic heart failure requiring surgical revascularization. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Heart Failure Patients, Cardiac Ischemia
- What is being tested?
- Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteAustria
- Study dates
- 16 Nov 2018to 15 Mar 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between 21 and 90 years of age undergoing primary coronary artery bypass grafting
- Presentation with reduced left ventricular function, defined as LVEF ≤ 40% measured by cardiac MRI
- Presentation with regional left ventricular wall motion abnormalities
- Written informed consent from the patient for participation in the study
Who cannot join
- Significant concomitant aortic valve disease requiring surgical treatment (other than significant aortic valve disease not detected in preoperative cardiac ultrasound but detected during surgery)
- Serious radiographic contrast allergy
- Patient in cardiogenic shock or presenting with acute myocardial infarction (STEMI or NSTEMI)
- Patient with a contraindication for cardiac MRI
- History of significant ventricular arrhythmia, other than MI-associated arrhythmia
- Comorbidity reducing life expectancy to less than one year
Show all 9Show fewer
- Presence of a ventricular thrombus
- Presence of a cardiac tumour
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Innsbruck - Competence Center for Clinical Trials
Innsbruck, Tyrol, 6020
About this study
This randomised, controlled clinical trial aims to evaluate the safety and efficacy of Cardiac Shockwave Therapy (CAST-HF) in patients with ischaemic heart failure requiring surgical revascularization. The main questions to answer are:
- Does cardiac shockwave therapy, in addition to CABG surgery, improve left ventricular ejection fraction?
- Is cardiac shockwave therapy in addition to CAGB surgery safe?
Participants will be randomised into intervention (cardiac shockwave therapy) and control (sham treatment with an inactive applicator) groups.
Read the detailed description
This study investigates the safety and performance characteristics of the Direct Epicardial Shockwave Therapy System (DESWT) as applied with the Cardiac Shockwave Probe (CSP).
- Conditions
- Heart Failure Patients, Cardiac Ischemia
- Being tested
- Shockwave Therapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave TherapyDevice
The cardiac shockwave system consists of a table-top device (Nonvasiv Medical GmbH, Konstanz, Germany) and a sterile single-use applicator releasing electrohydraulic shockwaves (Heart Regeneration Technologies GmbH, Innsbruck, Austria). Prior to use, the applicator is inserted into a sterile cover containing ultrasound gel. In order to ensure acoustic coupling between the applicator and the myocardium, continuous saline rinsing is applied throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | In the intervention arm, 300 shockwave impulses per coronary supply territory, at an energy flux density of 0.38mJ/mm2 and a frequency 3Hz, are applied in direct contact with the ischaemic myocardium of the left ventricle. The intervention is performed during CABG surgery after bypasses are fully established while still on cardiopulmonary bypass. Receives: Device: Shockwave Therapy |
| Sham Control Arm | No intervention | In the sham control arm, the same manipulations are performed with an inactive shockwave applicator in direct contact with the ischaemic myocardium of the left ventricle as in the intervention arm. The sham treatment is performed during CABG surgery after bypasses are fully established while still on cardiopulmonary bypass. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 360 days.
The primary efficacy objective is to assess the efficacy of cardiac shock wave therapy in patients undergoing primary coronary artery bypass grafting and suffering from reduced left ventricular function ≤ 40%
Measured: 360 days
The primary safety endpoint is the occurrence of device-related complications (adverse device effects or serious adverse device effects) within 360 days.
The primary safety objective is to assess the safety profile of the cardiac shock wave therapy device.
Measured: 360 days
Secondary outcomes (2)
Secondary efficacy-related endpoints include patient-reported outcomes.
Change in:
- 6- Minute Walk Test Distance
- NYHA functional class
- Serum nt-proBNP levels
- Renal function (GFR)
- Seattle Angina Pectoris Questionnaire (SAQ)
- 36-item short-form survey (SF36)
- Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Measured: 360 days
Secondary safety-related endpoints include patient-reported outcomes.
- Occurance of ventricular arrhythmia during hospital stay
- Occurrence of device-related peri-operative myocardial damage detected by rise of cardiac biomarkers (CK-MB, TropT) Occurrence of signs of device-related infection (CRP, leucocytosis) during hospital stay
Measured: 6 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start16 Nov 2018
- Primary completion1 Jun 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure PatientsStudies 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
- Model description
- This study investigates the safety and performance characteristics of the Direct Epicardial Shockwave Therapy System (DESWT) as applied with the Cardiac Shockwave Probe (CSP) vs. Sham treatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Holfeld, MD, Principal investigator, University Hospital for Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859466
- Sponsor's protocol ID
- CIP-HEART-001
- Acronym
- CAST-HF
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2018
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nagele F, Polzl L, Graber M, Hirsch J, Mayr A, Pamminger M, Troger F, Theurl M, Schreinlechner M, Sappler N, Dorfmuller C, Mitrovic M, Ulmer H, Grimm M, Gollmann-Tepekoylu C, Holfeld J. Safety and efficacy of direct cardiac shockwave therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial-an update. Trials. 2022 Dec 9;23(1):988. doi: 10.1186/s13063-022-06931-4.
PubMed 36494706Polzl L, Nagele F, Graber M, Hirsch J, Lobenwein D, Mitrovic M, Mayr A, Theurl M, Schreinlechner M, Pamminger M, Dorfmuller C, Grimm M, Gollmann-Tepekoylu C, Holfeld J. Safety and efficacy of direct Cardiac Shockwave Therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial. Trials. 2020 May 30;21(1):447. doi: 10.1186/s13063-020-04369-0.
PubMed 32473644
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT03859466
- Acronym / sponsor ID
- CAST-HF / CIP-HEART-001
- Conditions
- Heart Failure Patients, Cardiac Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 1 Mar 2019 (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.
This randomised, controlled clinical trial aims to evaluate the safety and efficacy of Cardiac Shockwave Therapy (CAST-HF) in patients with ischaemic heart failure requiring surgical revascularization. The main questions to answer are:
- Does cardiac shockwave therapy, in addition to CABG surgery, improve left ventricular ejection fraction?
- Is cardiac shockwave therapy in addition to CAGB surgery safe?
Participants will be randomised into intervention (cardiac shockwave therapy) and control (sham treatment with an inactive applicator) groups.
Detailed description
This study investigates the safety and performance characteristics of the Direct Epicardial Shockwave Therapy System (DESWT) as applied with the Cardiac Shockwave Probe (CSP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study investigates the safety and performance characteristics of the Direct Epicardial Shockwave Therapy System (DESWT) as applied with the Cardiac Shockwave Probe (CSP) vs. Sham treatment
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Shockwave TherapyIn the intervention arm, 300 shockwave impulses per coronary supply territory, at an energy flux density of 0.38mJ/mm2 and a frequency 3Hz, are applied in direct contact with the ischaemic myocardium of the left ventricle. The intervention is performed during CABG surgery after bypasses are fully established while still on cardiopulmonary bypass. |
| Sham Control Arm | No intervention | –In the sham control arm, the same manipulations are performed with an inactive shockwave applicator in direct contact with the ischaemic myocardium of the left ventricle as in the intervention arm. The sham treatment is performed during CABG surgery after bypasses are fully established while still on cardiopulmonary bypass. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients between 21 and 90 years of age undergoing primary coronary artery bypass grafting
- Presentation with reduced left ventricular function, defined as LVEF ≤ 40% measured by cardiac MRI
- Presentation with regional left ventricular wall motion abnormalities
- Written informed consent from the patient for participation in the study
Key exclusion criteria (9 listed)
- Significant concomitant aortic valve disease requiring surgical treatment (other than significant aortic valve disease not detected in preoperative cardiac ultrasound but detected during surgery)
- Serious radiographic contrast allergy
- Patient in cardiogenic shock or presenting with acute myocardial infarction (STEMI or NSTEMI)
- Patient with a contraindication for cardiac MRI
- History of significant ventricular arrhythmia, other than MI-associated arrhythmia
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 |
|---|---|---|
| Shockwave TherapyThe cardiac shockwave system consists of a table-top device (Nonvasiv Medical GmbH, Konstanz, Germany) and a sterile single-use applicator releasing electrohydraulic shockwaves (Heart Regeneration Technologies GmbH, Innsbruck, Austria). Prior to use, the applicator is inserted into a sterile cover containing ultrasound gel. In order to ensure acoustic coupling between the applicator and the myocardium, continuous saline rinsing is applied throughout the procedure. | Device | Intervention Arm |
Primary outcome
The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 360 days.
Time frame: 360 days
The primary efficacy objective is to assess the efficacy of cardiac shock wave therapy in patients undergoing primary coronary artery bypass grafting and suffering from reduced left ventricular function ≤ 40%
The primary safety endpoint is the occurrence of device-related complications (adverse device effects or serious adverse device effects) within 360 days.
Time frame: 360 days
The primary safety objective is to assess the safety profile of the cardiac shock wave therapy device.
2 secondary outcomes
Secondary efficacy-related endpoints include patient-reported outcomes.
Time frame: 360 days
Secondary safety-related endpoints include patient-reported outcomes.
Time frame: 6 Days
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 19 Oct 2023.
- Derived from this study: PubMed 36494706Nagele F, Polzl L, Graber M, Hirsch J, Mayr A, Pamminger M, Troger F, Theurl M, Schreinlechner M, Sappler N, Dorfmuller C, Mitrovic M, Ulmer H, Grimm M, Gollmann-Tepekoylu C, Holfeld J. Safety and efficacy of direct cardiac shockwave therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial-an update. Trials. 2022 Dec 9;23(1):988. doi: 10.1186/s13063-022-06931-4.
- Derived from this study: PubMed 32473644Polzl L, Nagele F, Graber M, Hirsch J, Lobenwein D, Mitrovic M, Mayr A, Theurl M, Schreinlechner M, Pamminger M, Dorfmuller C, Grimm M, Gollmann-Tepekoylu C, Holfeld J. Safety and efficacy of direct Cardiac Shockwave Therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial. Trials. 2020 May 30;21(1):447. doi: 10.1186/s13063-020-04369-0.
- Cardiac Regeneration Research LabLink provided by the sponsor.
- Trial HomepageLink provided by the sponsor.
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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.
Johannes Holfeld, MD principal investigator
University Hospital for Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave Therapy in people with Heart Failure Patients and Cardiac Ischemia, run by Medical University Innsbruck at 1 site in Austria.
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 9 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 19 Oct 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 Austria. 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?
The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 360 days. (time frame: 360 days). The study lists 2 primary outcomes in all. 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 NCT03859466, which also lists 2 linked publications.
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 Oct 2023.