NCT03945643

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

Completed EARLY_PHASE1 Last updated 14 August 2023

What this trial tests

EARLY_PHASE1 trial testing Sildenafil in Patent Foramen Ovale in 82 participants. Completed in 31 July 2023.

Timeline

1 July 2019

Primary endpoint
31 January 2023

31 July 2023

Quick facts

Lead sponsor	University of Oregon
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	82
Start date	1 July 2019
Primary completion	31 January 2023
Estimated completion	31 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Sildenafil (sildenafil) — full drug profile →
• Placebo

Conditions studied

• Patent Foramen Ovale — all drugs for Patent Foramen Ovale →
• Intrapulmonary Arteriovenous Anastamosis — all drugs for Intrapulmonary Arteriovenous Anastamosis →

Sponsor

University of Oregon

Who can join

Adults 18 to 65, any sex, with Patent Foramen Ovale or Intrapulmonary Arteriovenous Anastamosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cardiac Effects of Phosphodiesterase-5 Inhibitors: Efficacy and Safety.
   Roy S, Kloner RA, Salloum FN, Jovin IS. · · 2023 · cited 17× · PMID 34652581 · DOI 10.1007/s10557-021-07275-y