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Is Blood Flow Through IPAVA and PFO Related to Breath-hold and SCUBA Diving-induced Pulmonary Hypertension?

NCT03945643 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-08-14

No results posted yet for this study

Summary

In summary, the investigators propose to study elite Croatian breath-hold and SCUBA divers. The investigators will quantify breath-hold hypoxia- and SCUBA diving-induced pulmonary hypertension and right heart function to investigate the relationships between PFO and IPAVA blood flow. The investigators will use a placebo-controlled intervention (sildenafil) to reduce pulmonary arterial pressure in these subjects to examine the impact of the change in pressure (or absence of change) on the relationships determined above.

Conditions

  • Patent Foramen Ovale
  • Intrapulmonary Arteriovenous Anastamosis

Interventions

DRUG

Sildenafil

50mg administration of sildenafil, one time, one hour prior to measurements.

OTHER

Placebo

50mg administration in gel-encapsulated microcrystalline cellulose one time, one hour prior to measurements.

Sponsors & Collaborators

  • University of Oregon

    lead OTHER

Principal Investigators

  • Andrew Lovering, PhD · University of Oregon

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2023-01-31
Completion
2023-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03945643 on ClinicalTrials.gov