Pulmonary Hypertension Clinical Trial
— KEPAHOfficial title:
Ketone Administration in Patients With Pulmonary Hypertension - Effects on Hemodynamics
Verified date | July 2020 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In the present study, patients with idiopathic pulmonary hypertension (IPAH) and chronic thromboembolic pulmonary hypertenion will be investigated in a randomized cross-over design with ketone infusions and placebo. Invasive and non-invasive hemodynamics will be evaluated
Status | Completed |
Enrollment | 20 |
Est. completion date | November 29, 2021 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Persistent pulmonary hypertension (defined as PVR > 3 WU, pulmonary capillary wedge pressure (PCWP) < 15 mmHG, mean pulmonary arterial pressure (mPAP) =25 mmHg) on the most resent right heart catheterization. - Preserved left ventricular ejection fraction (<50%) on most recent echocardiography - Able to give informed consent Exclusion Criteria: - Other Significant pulmonary, mitral or aortic valve disease - Other disease or treatment making subject unsuitable for study participation |
Country | Name | City | State |
---|---|---|---|
Denmark | Dept. of cardiology, Aarhus University hospital Skejby, | Aarhus | Region Midjylland |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Danish Heart Foundation |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac output (L/min | Measured by Swan-Ganz monitoring | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | mixed venous saturation (%) | Hemodynamics - Swan Ganz monitoring | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | systemic blood pressure (mmHg) | Hemodynamics - non-invasive blood pressure measurement | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | pulmonary capillary pressure (mmHg) | Hemodynamics - Swan Ganz monitoring | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | Pulmonary pressure (mmHg) | Hemodynamics - Swan Ganz monitoring | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | TAPSE (mm) | Echocardiography | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | RV strain (%) | Echocardiography | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | LV strain (%) | Echocardiography | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | systolic tricuspid plane velocity (cm/sec) | Echocardiography | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | Left ventricular ejection fraction (%) | Echocardiography | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | Changes in Prostaglandines (pmol/L) | Blood samples | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | pH | Blood samples | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | sodium (mM) | Blood samples | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | potassium (mM) | Blood samples | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion | |
Secondary | lactate (mM) | Blood samples | changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion |
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