Heart FailureNCT03923673
Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure
A study testing Pericardiotomy in people with Heart Failure, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are studying the safety and efficacy of a minimally invasive treatment called a pericardiotomy, which creates a small opening in the sac that surrounds the heart. Researchers will test the short and long term effects of this procedure by monitoring subjects heart function and symptoms. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pericardiotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 15 Oct 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 30 years
- Symptoms of severe dyspnea (III-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
- EF of > or = 50% determined on most recent imaging study within the preceding 5 years, with no change in clinical status suggesting potential for deterioration in systolic function
- One of the following:
- Previous hospitalization for HF with radiographic evidence (pulmonary venous hypertension, vascular congestion, interstitial edema, pleural effusion) of pulmonary congestion or
- Catheterization documented elevated filling pressures at rest (PCWP ≥15 or LVEDP ≥18) or with exercise (PCWP ≥25) or
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- Elevated NT-proBNP (>400 pg/ml) or BNP(>200 pg/ml) or
- Echo evidence of diastolic dysfunction/elevated filling pressures manifest by medial E/e' ratio≥15 and/or left atrial enlargement and chronic treatment with a diuretic for signs or symptoms of heart failure
- Heart failure is primary factor limiting activity as indicated by answering # 2 to the following question: My ability to be active is most limited by:
- Joint, foot, leg, hip or back pain
- Shortness of breath and/or fatigue and/or chest pain
- Unsteadiness or dizziness
- Lifestyle, weather, or I just don't like to be active
- Ambulatory (not wheelchair / scooter dependent)
Who cannot join
- Recent (< 1 month) hospitalization for heart failure
- Left or right ventricular dilatation noted on cardiac imaging study prior to enrollment (either echocardiography or MRI).
- Any hemoglobin (Hgb) < 8.0 g/dl within 30 days prior to randomization
- Any GFR < 20 ml/min/1.73 m2 within 30 days prior to randomization
- Significant alternative cause of dyspnea such as severe chronic obstructive pulmonary disease that is a primary contributor to symptoms in the opinion of the investigator
- Ischemia thought to contribute to dyspnea in the opinion of the investigator
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- Acute coronary syndrome within 3 months defined by electrocardiographic (ECG) changes and biomarkers of myocardial necrosis (e.g., troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent)
- PCI, coronary artery bypass grafting, or new biventricular pacing within past 3 months
- Obstructive hypertrophic cardiomyopathy
- Known infiltrative cardiomyopathy (amyloid)
- Pericardial disease (constriction, pericarditis, tamponade)
- Active myocarditis
- Complex congenital heart disease
- Active collagen vascular disease
- Significant valvular heart disease (greater than mild stenosis or greater than moderate regurgitant lesions)
- Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR > 1.7 in the absence of anticoagulation treatment
- Terminal illness (other than HF) with expected survival of less than 1 year
- Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months.
- Inability to comply with planned study procedures
- Pregnancy or breastfeeding mothers
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice)
Researchers are studying the safety and efficacy of a minimally invasive treatment called a pericardiotomy, which creates a small opening in the sac that surrounds the heart. Researchers will test the short and long term effects of this procedure by monitoring subjects heart function and symptoms.
- Conditions
- Heart Failure
- Being tested
- Pericardiotomy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PericardiotomyProcedure or surgery
The minimally invasive procedure that creates a small opening in the sac that surrounds the heart.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Heart Failure with Preserved Ejection Fraction | Experimental | Subjects with Heart Failure with Preserved Ejection Fraction (HFpEF) will receive a minimally invasive treatment called a pericardiotomy. Receives: Procedure: Pericardiotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac and Cerebrovascular Events
The number of major cardiac and cerebrovascular events reported.
Measured: 6 months
Change in left ventricular filling pressures during volume loading
The number of subjects to demonstrate an increase in pulmonary capillary wedge pressure in response to volume loading after pericardiotomy vs. prior to pericardiotomy.
Measured: baseline, 6 months
Secondary outcomes (2)
Change in Quality of Life
Measured using Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: baseline, 6 months
Change in exercise capacity
Measured by Cardiopulmonary Exercise Testing
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 May 2019
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry Borlaug, Mayo Clinic
- Investigators
- Barry A Borlaug, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923673
- Sponsor's protocol ID
- 18-010106
- Status last verified
- Aug 2022
- First submitted
- 16 Apr 2019
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice)
- ClinicalTrials.gov ID
- NCT03923673
- Acronym / sponsor ID
- 18-010106
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 22 Apr 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.
Researchers are studying the safety and efficacy of a minimally invasive treatment called a pericardiotomy, which creates a small opening in the sac that surrounds the heart. Researchers will test the short and long term effects of this procedure by monitoring subjects heart function and symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Heart Failure with Preserved Ejection Fraction | Experimental | Procedure: PericardiotomySubjects with Heart Failure with Preserved Ejection Fraction (HFpEF) will receive a minimally invasive treatment called a pericardiotomy. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 30 years
- Symptoms of severe dyspnea (III-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
- EF of > or = 50% determined on most recent imaging study within the preceding 5 years, with no change in clinical status suggesting potential for deterioration in systolic function
- One of the following:
- Heart failure is primary factor limiting activity as indicated by answering # 2 to the following question: My ability to be active is most limited by:
Key exclusion criteria (20 listed)
- Recent (< 1 month) hospitalization for heart failure
- Left or right ventricular dilatation noted on cardiac imaging study prior to enrollment (either echocardiography or MRI).
- Any hemoglobin (Hgb) < 8.0 g/dl within 30 days prior to randomization
- Any GFR < 20 ml/min/1.73 m2 within 30 days prior to randomization
- Significant alternative cause of dyspnea such as severe chronic obstructive pulmonary disease that is a primary contributor to symptoms in the opinion of the investigator
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 |
|---|---|---|
| PericardiotomyThe minimally invasive procedure that creates a small opening in the sac that surrounds the heart. | Procedure or surgery | Subjects with Heart Failure with Preserved Ejection Fraction |
Primary outcome
Major Adverse Cardiac and Cerebrovascular Events
Time frame: 6 months
The number of major cardiac and cerebrovascular events reported.
Change in left ventricular filling pressures during volume loading
Time frame: baseline, 6 months
The number of subjects to demonstrate an increase in pulmonary capillary wedge pressure in response to volume loading after pericardiotomy vs. prior to pericardiotomy.
2 secondary outcomes
Change in Quality of Life
Time frame: baseline, 6 months
Change in exercise capacity
Time frame: baseline, 6 months
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 2 Aug 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Barry A Borlaug, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericardiotomy in people with Heart Failure, run by Mayo Clinic at 1 site in United States.
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 14 inclusion and 20 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 2 Aug 2022. 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 United States. 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?
Major Adverse Cardiac and Cerebrovascular Events (time frame: 6 months). 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?
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 2 Aug 2022.