Clinical trial NCT03923673: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure
Official title: TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 4
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria

* 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
  * 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)

Exclusion Criteria

* 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
* 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

Primary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events
timeFrame: 6 months
measure: Change in left ventricular filling pressures during volume loading
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: baseline, 6 months
measure: Change in exercise capacity
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barry A Borlaug, MD
role: PRINCIPAL_INVESTIGATOR
References: