Cardiogenic ShockDigital healthDevice
What this study is
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
What's being tested
- CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization
Intervention · DEVICE
Implantation of CardioMEMS Device in patients following admission for Cardiogenic shock, with regular ambulatory pulmonary artery pressure monitoring and medication optimization for the treatment of heart failure.
Study details
- Sponsor
- Inova Health Care Services
- Conditions
- Cardiogenic Shock · Heart Failure · Ambulatory Hemodynamic Monitoring
- Enrolling
- 40 people
- Starts
- 2020-12-31
- Est. completion
- 2028-12-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Subject or legal representative has signed Informed Consent Form (ICF) and the patient has the capacity to participate in the study and complete the study questionnaires, in the estimation of the study investigator.
- Age ≥ 18 years
- NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF).
- Survive to discharge during a current hospital admission with cardiogenic shock (CS) as defined by clinical criteria previously used in cardiogenic shock trials: systolic blood pressure < 90 mmHg for > 30 minutes or requiring infusion of catecholamines to maintain the systolic blood pressure above 90 mmHg, with evidence of end-organ dysfunction such as pulmonary edema or impaired end-organ perfusion including altered mentation, oliguria with urine output < 30 mL/h, or serum lactate > 2 mmol/L (5). Hemodynamic criteria include cardiac index ≤ 1.8 L/min/m2 without vasoactive pharmacologic agents, or cardiac index ≤ 2.2 L/min/m2 and pulmonary artery occlusion pressure ≥ 15 mmHg with vasoactive agents.
- Patients must have internet and phone access (to allow communication of the implanted device with the researchers).
You can't join if
- Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator.
- Treatment with ongoing mechanical circulatory support (MCS) such as a durable left ventricular assist device (LVAD) or recipient of a heart transplantation for the treatment of cardiogenic shock during the index hospitalization for CS.
- If of childbearing potential with a positive pregnancy test.
- Transition to hospice care.
- Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation.
- Presence of an active, uncontrolled infection.
- Any condition other than heart failure that could limit survival to less than 6 months
- Discharge to facility other than acute rehabilitation or to the ambulatory setting.
- No access to internet or phone.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openInova Fairfax Medical Campus
Falls Church, Virginia, United States
- Bhruga Shah, MS, BSN · Contact703-776-2828Bhruga.shah@inova.org
- Kedir Seid · Contact17037762524kedir.Seid@inova.org
- Shashank Sinha, MD MSc · Principal investigator
Recruiting
Study team
Sponsor
Inova Health Care Services
Study ID U19-05-3608
Principal investigator
Shashank Sinha, MD MSc
Inova Fairfax Medical Campus
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.