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

07302018.031

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.

2019-07-01

2023-01-31

2023-07-31

Completed

Early phase I

82

Inclusion Criteria: * Reside in geographic location near Split, Croatia * Elite breath hold divers * Experienced SCUBA divers Exclusion Criteria: * Previous history of coronary artery disease * Currently taking medication or herbal supplement for any heart or respiratory disease that cannot be ceased for 48 hours prior to testing * Women who are pregnant or trying to become pregnant * Previous history of any condition that would prevent the subject from performing a breath hold * Taking sildenafil or products similar to sildenafil * Taking Nitrates or other nitric oxide donors * Control breath hold divers can't have previous breath hold diving experience

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Breath hold divers will be administered sildenafil and placebo. Age-matched controls will be administered sildenafil and placebo.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Utilization of placebo to mask drug administration.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 82, 'type': 'ACTUAL'}}

2023-08-14