Ketones for Pulmonary Hypertension - Effects on Hemodynamics

NCT04615754 | Completed Phase 2 DMC

• 1 other identifier: 1-10-72-232-19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pulmonary Hypertension; Ketonemia

Keywords

Right sided heart catheterization; Echocardiography; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• mixed venous saturation (%)

  changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion

• systemic blood pressure (mmHg)

  changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion

• pulmonary capillary pressure (mmHg)

  changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion

• Pulmonary pressure (mmHg)

  changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion

• TAPSE (mm)

  changes during the infusion for 2.5 hours compared to 2.5 hours of Saline infusion

Study Arms (2)

3-OHB vs Saline

EXPERIMENTAL

3-OHB will be infused for 2.5 hours in IPAH (n=5) and CETPH (n=5) patients- 6 in each group is recruited for taking drop-out into account

Dietary Supplement: Hyperketonemia - use of ketone (3-OHB) infusion; Dietary Supplement: Placebo - use of saline infusion

Saline vs 3-OHB

EXPERIMENTAL

Saline will be infused for 2.5 hours in IPAH (n=5) and CETPH (n=5) patients- 6 in each group is recruited for taking drop-out into account

Dietary Supplement: Hyperketonemia - use of ketone (3-OHB) infusion; Dietary Supplement: Placebo - use of saline infusion

Interventions

Hyperketonemia - use of ketone (3-OHB) infusion DIETARY_SUPPLEMENT

The effect of intravenous ketone supplement

3-OHB vs Saline; Saline vs 3-OHB

Placebo - use of saline infusion DIETARY_SUPPLEMENT

Saline is infused as an comparator

3-OHB vs Saline; Saline vs 3-OHB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other Significant pulmonary, mitral or aortic valve disease
• Other disease or treatment making subject unsuitable for study participation

Sponsors & Collaborators

• University of Aarhus: lead
• Danish Heart Foundation: collaborator

Study Sites (1)

Dept. of cardiology, Aarhus University hospital Skejby,

Aarhus, Region Midjylland, 8200, Denmark

Location

Related Publications (1)

• Nielsen R, Christensen KH, Gopalasingam N, Berg-Hansen K, Seefeldt J, Homilius C, Boedtkjer E, Andersen MJ, Wiggers H, Moller N, Botker HE, Mellemkjaer S. Hemodynamic Effects of Ketone Bodies in Patients With Pulmonary Hypertension. J Am Heart Assoc. 2023 May 16;12(10):e028232. doi: 10.1161/JAHA.122.028232. Epub 2023 May 15.

  PMID: 37183871 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Ketosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Roni R Nielsen, MD PhD

  Dept. of Cardiology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and the endpoint-assessor will be masked to intevention
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized cross-over I.e. Ketone infusion is compared to saline infusion in a randomised cross-ove design. (Ketones are considered dietary supplement as glucose or lipids)

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: November 4, 2020
• Study Start: August 18, 2020
• Primary Completion: May 1, 2021
• Study Completion: November 29, 2021
• Last Updated: December 2, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)