A Study of Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure

Overview

About this study

The purpose of this study is to demonstrate acute effectiveness and safety of minimally-invasive pericardiotomy in patients with Heart Failure (HFpEF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 30 years old.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barry Borlaug, M.D.

Closed for enrollment

Contact information:

Laura Verbout-Kveene B.S.

(507)422-5241

Kveene.Laura@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20455324

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