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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04615754
Other study ID # 1-10-72-232-19
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 18, 2020
Est. completion date November 29, 2021

Study information

Verified date July 2020
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Pulmonary hypertension (PH) is a debilitating disease that affects both the pulmonary vasculature and the heart. It is associated with increased mortality and hospitalization and impairs daily life for the affected patients. Despite substantial advances in treatment within the past decade the prognosis remains poor with an 1-year mortality of more than 10%.1 The pathophysiology of PH is multifactorial and can be caused by left sided cardiac disease, pulmonary pathophysiological changes in the pulmonary vessels, respiratory diseases and pulmonary embolism.The treatment is targeted at the underlying cause. Hence, left sided heart disease is treated with anticongestive medications4 and respiratory disease by pulmonary medications. However, pulmonary vascular diseases such as chronic thromboembolic pulmonary hypertension (CTEPH) and idiopathic pulmonary arterial hypertension (IPAH) are treated with pulmonary endarterectomy and vasodilators targeting the pulmonary vasculature, respectively. However, not all patients have an optimal pulmonary hemodynamic response on treatment. If patients are left with persistent pulmonary hypertension the disease may progress further and cause right heart failure which worsens the prognosis. Data from a recent study conducted at the investigator's institution demonstrated 40% increase in cardiac output during infusion of the ketone body 3-hydroxybutyrate (3-OHB). Intriguingly, this was associated with an increase in RV function and a decrease in the pulmonary vascular resistance of approximately 20%. In the present study, 10 patients with IPAH and 10 patients with CETPH will be subjected to placebo and 3-OHB infusion in a randomized cross-over design. Each of the infusions will be given for 2.5 hours and cross-over will be carried out on the same day. Echocardiography and right sided heart catheterization will be applied and blood will be sampled.


Recruitment information / eligibility

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

Study Design


Intervention

Dietary Supplement:
Hyperketonemia - use of ketone (3-OHB) infusion
The effect of intravenous ketone supplement
Placebo - use of saline infusion
Saline is infused as an comparator

Locations

Country Name City State
Denmark Dept. of cardiology, Aarhus University hospital Skejby, Aarhus Region Midjylland

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Danish Heart Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

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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