Status:
COMPLETED
Establishing Correlation Between Non-invasive Pulmonary Blood Pressure Readings and Swan-Ganz Results
Lead Sponsor:
Suremedix Ltd
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Pulmonary hypertension (PH) is prognostic indicator in heart failure patients for poor outcome, however, it is challenging for monitoring. The current study is designed to explore whether data generat...
Eligibility Criteria
Inclusion
- Heart Failure patient scheduled for right heart catheterization (Swan-Ganz)
- Age range: 18 - 80 years
- Pulmonary artery systolic pressure values ≤50 mmHg according to Swan - Ganz measurement
- Able and willing to sign informed consent
Exclusion
- History or current diagnosis of asthma or any other significant pulmonary disease
- Jugular access site
- Atrial fibrillation
- Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
- Requirement for any ventilator support (including CPAP or BPAP)
- Use of long-term oxygen therapy
- Known upper airway obstruction
- Known susceptibility to pneumothorax or pneumothorax in the medical history
- Chest surgery or pacemaker implantation in the prior 6 months
- Significant primary valvular disease
- Major cardiovascular event within the prior 3 months
- Current heavy smoker (more than one pack per day)
- Any diagnosed respiratory tract infection (including upper respiratory tract), airway or lung disease or COPD exacerbation in the prior 3 months
- Female patient pregnant or breast-feeding or planning to be pregnant in the next year
- Diagnosis of Obstructive Sleep Apnea
- Unexplained muscle weakness. Unable to comfortably lie down for 30 minutes
- Current hospitalization due to CHF deterioration
- Patients with a Body Mass Index (BMI) ≥ 40kg/m2
- Any condition that the PI believes could interfere with the intent of the study or would make participation not in the best interest of the patient
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04509089
Start Date
December 1 2020
End Date
March 1 2021
Last Update
August 4 2021
Active Locations (1)
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1
Rabin Medical Center
Petah Tikva, Israel, 49100