HA Residents With PVD, SDB Assessed at HA (2840m) vs LA (Sea Level)

• Sponsor: University of Zurich (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06072417
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.3
• Patients Per Site Per Month: 7.3

Study Details

Study Description

Brief Summary

To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on sleep disordered breathing

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Vascular Disease; Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension	Other: Assessment without intervention at High altitude; Other: Relocation to sea level for 2 days	N/A

Detailed Description

This research in patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA

2500 (PVDHA) will have nocturnal respiratory sleep studies near their living altitude in Quito at 2840m and at sea level in Pedernales during the first and the second night after relocation.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Patients living permanently >2500m around Quito (Equador) will be assessed at 2840m and after relocation to sea levelPatients living permanently >2500m around Quito (Equador) will be assessed at 2840m and after relocation to sea level
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparative Study of Sleep Disordered Breathing (SDB) in Patients With Pulmonary Vascular Diseases Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 2840m vs. at Low Altitude (LA) Sea Level
• Actual Study Start Date: Sep 22, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Respiratory sleep study at 2840m Participants will have a respiratory sleep study by polygraphy near their resident altitude at 2840m	Other: Assessment without intervention at High altitude; Assessments at High altitude corresponding to Baseline measures
Experimental: Respiratory sleep study near sea level (0-30m) Participants will have a respiratory sleep study by polygraphy near sea level (0-30m)	Other: Relocation to sea level for 2 days; Participants will be relocated to sea level and intervention and have assessements there.

Outcome Measures

Primary Outcome Measures

1. Mean nocturnal SpO2 at LA vs. HA [during the first night at low altitude (of intervention)]

   Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m)

Secondary Outcome Measures

1. Mean nocturnal SpO2 at LA vs. HA [during the second night at low altitude (of intervention)]

   Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m)

2. Time spent with SpO2<90% at LA vs. HA [during the first and second night at low altitude (of intervention)]

   Change in time spent with SpO2<90% between LA (sea level) vs HA (2840 m)

3. AHI at LA vs. HA [during the first and second night at low altitude (of intervention)]

   Change in apnea-hypopnea index (AHI) between LA (sea level) vs HA (2840 m)

4. ODI at LA vs. HA [during the first and second night at low altitude (of intervention)]

   Change in oxygen desaturation index (ODI) between LA (sea level) vs HA (2840 m)

5. Time spent with periodic breathing at LA vs. HA [during the first and second night at low altitude (of intervention)]

   Change in time spent with periodic breathingbetween LA (sea level) vs HA (2840 m)

6. Heart rate variability at LA vs. HA [during the first and second night at low altitude (of intervention)]

   Change in heart rate variability between LA (sea level) vs HA (2840 m)

7. ECG markers of repolarization at LA vs. HA [during the first and second night at low altitude]

   Change in electrocardiogram (ECG) markers of repolarization (QT time) between LA (sea level) vs HA (2840 m)

8. pulse transit time drops at LA vs. HA [during the first and second night at low altitude]

   Change in pulse transit time drops between LA (sea level) vs HA (2840 m)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients 18-80 years old of both genders,

• Residence > 2500m of altitude

• diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) >20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 WU (wood units) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines

• Patients stable on therapy

• NYHA (new york heart association) functional class I-III

• Provided written informed consent to participate in the study.

Exclusion Criteria:

• Age <18 years or >80 years

• unstable condition

• Patients who cannot follow the study investigations, patient permanently living < 2500m.

• Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)

• Severely hypoxemic patients at Quito permanently have persistent SpO2 (oxygen saturation by pulseoximetry) <80% on ambient air.

• Patients with chronic mountain sickness (Hemoglobin > 19 g/dl in women, >21 g/dl in men)

• Patient with a non-corrected ventricular septum defect

• Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin<11 g/dl)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich	Zurich		Switzerland	8091

Sponsors and Collaborators

• University of Zurich

Investigators

• Principal Investigator: Silvia Ulrich, Prof. Dr., University Hospital Zurich, Departement of Pulmonology
• Principal Investigator: Rodrigo Hoyos, Dr., Carlos Adrade Marin Hospital of Quito, Equador

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT06072417
• Other Study ID Numbers: PVD_HAvsLA_SDB
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Zurich: Pulmonary Hypertension; Hypoxia; sleep disordered breathing; Pulmonary arterial hypertension; Chronic Thromboembolic Pulmonary Hypertension; High altitude
• Additional relevant MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension; Vascular Diseases

Study Results

No Results Posted as of Oct 10, 2023