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

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Assessment without intervention at High altitude

Relocation to sea level for 2 days

About this trial

This is an interventional supportive care trial for Pulmonary Vascular Disease focused on measuring Pulmonary Hypertension, Hypoxia, sleep disordered breathing, Pulmonary arterial hypertension, Chronic Thromboembolic Pulmonary Hypertension, High altitude

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Respiratory sleep study at 2840m

Respiratory sleep study near sea level (0-30m)

Arm Description

Participants will have a respiratory sleep study by polygraphy near their resident altitude at 2840m

Participants will have a respiratory sleep study by polygraphy near sea level (0-30m)

Outcomes

Primary Outcome Measures

Mean nocturnal SpO2 at LA vs. HA

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

Secondary Outcome Measures

Mean nocturnal SpO2 at LA vs. HA

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

Time spent with SpO2<90% at LA vs. HA

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

AHI at LA vs. HA

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

ODI at LA vs. HA

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

Time spent with periodic breathing at LA vs. HA

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

Heart rate variability at LA vs. HA

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

ECG markers of repolarization at LA vs. HA

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

pulse transit time drops at LA vs. HA

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

Full Information

NCT ID

NCT06072417

First Posted

August 9, 2023

Last Updated

October 2, 2023

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT06072417

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 22, 2023 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Vascular Disease, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension

Keywords

Pulmonary Hypertension, Hypoxia, sleep disordered breathing, Pulmonary arterial hypertension, Chronic Thromboembolic Pulmonary Hypertension, High altitude

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Patients living permanently >2500m around Quito (Equador) will be assessed at 2840m and after relocation to sea level

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Respiratory sleep study at 2840m

Arm Type

Placebo Comparator

Arm Description

Participants will have a respiratory sleep study by polygraphy near their resident altitude at 2840m

Arm Title

Respiratory sleep study near sea level (0-30m)

Arm Type

Experimental

Arm Description

Participants will have a respiratory sleep study by polygraphy near sea level (0-30m)

Intervention Type

Other

Intervention Name(s)

Assessment without intervention at High altitude

Intervention Description

Assessments at High altitude corresponding to Baseline measures

Intervention Type

Other

Intervention Name(s)

Relocation to sea level for 2 days

Intervention Description

Participants will be relocated to sea level and intervention and have assessements there.

Primary Outcome Measure Information:

Title

Mean nocturnal SpO2 at LA vs. HA

Description

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

Time Frame

during the first night at low altitude (of intervention)

Secondary Outcome Measure Information:

Title

Mean nocturnal SpO2 at LA vs. HA

Description

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

Time Frame

during the second night at low altitude (of intervention)

Title

Time spent with SpO2<90% at LA vs. HA

Description

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

Time Frame